Surgisis® Biodesign™ Data Guide

Transcription

Surgisis® Biodesign™
CO O K M E D I CA L I N CO R P O R AT E D
P.O. Box 4195, Bloomington, IN 47402-4195 U.S.A.
Phone: 812.339.2235, Toll Free: 800.457.4500, Toll Free Fax: 800.554.8335
CO O K ( CA N A DA ) I N C .
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Phone: 905.640.7110, Toll Free: 800.668.0300
A D VA N C E D T I S S U E R E PA I R P R O D U C T S
W I L L I A M A . CO O K AU ST R A L I A P TY. LT D.
Brisbane Technology Park, 12 Electronics Street, Eight Mile Plains
Brisbane, QLD 4113 AUSTRALIA, Phone: +61 7 38 41 11 88
CO O K I R E L A N D LT D.
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Phone: 353 613 34440
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Data Guide
© COOK INCORPORATED 2007
SBDG0407
PEYRONIE’S REPAIR
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DURAL REPAIR
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Signals the Body
M arrow-derived cells populate scaffolds composed of xenogeneic extracellular matrix. 1.
Badylak SF, Park K, Peppas N, et al.
2. Small intestinal submucosa does not promote
Paiii tumor growth in Lobund–Wistar rats.
Hodde JP, Suckow MA, Wolter WR.
3. An investigation of the long-term bioactivity of
endogenous growth factor in oasis Wound Matrix. Hodde JP, Ernst DMJ, Hiles MC.
Randomized clinical trial comparing oasis Wound Matrix to Regranex Gel for diabetic ulcers.
4.
Niezgoda JA, Van Gils CC, Frykberg RG.
5. Effectiveness of an extracellular matrix graft (oasis Wound Matrix) in the treatment of chronic leg ulcers: a randomized clinical trial.
Mostow EN, Haraway GD, Dalsing M; OASIS Venus Ulcer Study Group.
Resistant to Infection
1. Preliminary experience with new bioactive prosthetic
material for repair of hernia in infected fields. Franklin ME Jr, Gonzalez JJ Jr, Michaelson RP, et al.
Use of porcine small intestinal submucosa as a prosthetic device for laparoscopic repair of hernias in contaminated fields: 2-year follow-up. 2.
Franklin ME Jr, Gonzalez JJ Jr, Glass JL.
Short-term outcomes with small intestinal submucosa for ventral abdominal hernia. 3.
Helton WS, Fisichella PM, Berger R, et al.
4. Comparison of small-intestinal submucosa and expanded
polytetrafluoroethylene as a vascular conduit in the presence of gram-positive contamination. Shell DH IV, Croce MA, Cagiannos C, et al.
5. Efficacy of anal fistula plug in closure of cryptoglandular fistulas: long-term follow-up.
Champagne BJ, O’Connor LM, Ferguson M, et al.
Complete Remodeling
1. Small intestinal submucosa for pubourethral sling suspension for the treatment of stress incontinence: first histopathological results in humans.
Wiedemann A, Otto M.
2. Treatment with bioscaffold enhances the fibril morphology and the collagen composition of healing medial collateral ligament in rabbits.
Woo SL, Takakura Y, Liang R, et al.
3. Histologic results 1 year after bioprosthetic repair of paraesophageal hernia in a canine model.
Desai KM, Diaz S, Dorward IG, et al.
Bilogical prothesis reduces recurrence after laparoscopic paraesophageal hernia repair: a multicenter, prospective, randomized trial.
4.
Oelschlager BK, Pellegrini CA, Hunter J, et al.
5. Use of a biodegradable patch for reconstruction of large thoracic cage defects in growing children.
Smith MD, Campbell RM.
Long-Term Strength
1. Strength over time of a resorbable bioscaffold for body wall repair in a dog model.
Badylak S, Kokini K, Tullius B, Whitson B.
2. Processed porcine small intestine submucosa as a graft
material for pubovaginal slings: durability and results.
Rutner AB, Levine SR, Schmaelzle JF.
3. Laparoscopic repair of inguinal hernia using Surgisis mesh and fibrin sealant.
Fine AP.
4.
Bioactive prosthetic material for treatment of hernias.
Edelman DS, Hodde JP.
5. Laparoscopic sacral colpopexy: comparison of nonresorbable prosthetic tape (Mersuture) and a sis collagen matrix (Surgisis es).
Grynberg M, Dedecker F, Staerman F.
Remodels into vascularized tissue, allowing
the body’s own defense mechanisms to reach
and respond to infection.
Complete Remodeling
Is undetectable once the healing process
is complete—providing a permanent repair
without a permanent material.
Long-term Strength
Over time, remodels to become as strong
as the patient’s own tissue.
SIGNALS THE BODY
RESISTANT TO INFECTION
COMPLETE REMODELING
Communicates with the body, signaling
surrounding tissue to grow across the
scaffold, allowing the body to restore itself.
LONG-TERM STRENGTH
Signals the Body
LONG-TERM STRENGTH
Signals
the Body
COMPLETE REMODELING
SIGNALS THE BODY
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A scientific review of:
Marrow-derived cells populate scaffolds composed of
xenogeneic extracellular matrix.
Badylak SF, Park K, Peppas N, et al.
Department of Biomedical Engineering, Purdue University, 1296 Potter Building, West Lafayette, IN 47907-1296, USA.
Exp Hematol. 2001;29:1310-18.
Abstract
Talking Points
INTRODUCTION: The source of cells that participate in wound repair
• Materials implanted in the body
directly affects outcome. The extracellular matrix (ECM) and other
acellular biomaterials have been used as therapeutic scaffolds for cell
attachment and proliferation and as templates for tissue repair. The
ECM consists of structural and functional proteins that influence cell
attachment, gene expression patterns, and the differentiation of cells.
OBJECTIVE: The objective of this study was to determine if the
can be inert or active, and the
types of cells that come to the
implant vary widely in source
and function.
• Bone marrow cells are known
composition of acellular matrix scaffolds affects the recruitment of bone
to be some of the most potent,
marrow-derived cellular elements that populate the scaffolds in vivo.
regenerative cells in the body,
METHODS: Scaffolds composed of porcine tissue ECM, purified
Type I collagen, poly(L)lactic coglycolic acid (PLGA), or a mixture of
and this study proves that SIS
attracts these cells to the site of
porcine ECM and PLGA were implanted into subcutaneous pouches
tissue repair better than other
on the dorsum of mice. The origin of cells that populated the matrices
resorbable materials.
was determined by first performing bone marrow transplantation to
convert the marrow of glucose phosphate isomerase 1b (Gpi-1(b))
mice to cells expressing glucose phosphate isomerase 1a (Gpi-1(a)).
RESULTS: A significant increase in Gpi-1(a) expressing cells was
present in sites implanted with the porcine ECM compared to sites
• Collagen is a necessary
structural component of
SIS, but the non-collagen
components of SIS are
implanted with either Type I collagen or PLGA. Use of recipient mice
responsible for the recruitment
transplanted with marrow cells that expressed beta-galactosidase
of specialized cells.
confirmed that the majority of cells that populated and remodeled the
naturally occurring porcine ECM were marrow derived. Addition of
porcine ECM to the PLGA scaffold caused a significant increase in the
number of marrow-derived cells that became part of the remodeled
implant site.
CONCLUSION: The composition of bioscaffolds affects the cellular
recruitment pattern during tissue repair. ECM scaffolds facilitate the
recruitment of marrow-derived cells into sites of remodeling.
Keywords: tissue engineering, interactive biomaterials, remodeling materials, stem cells.
Point #1: Materials implanted in the body can be inert or active, and the types of cells that come to the implant vary
widely in source and function.
Why is this important?
Scientists are just beginning to uncover the source of the cells that repopulate tissues undergoing the healing process.
For many years it has been assumed that the cells simply come from adjacent tissues in a migratory and localized fashion.
This assumption has been challenged by many studies, including this one, which show that blood-borne and marrowderived cells can and do translocate to the implant site. Further, the number and longevity of these cells in the repair site
can be modulated by the nature of the implant itself. All the materials tested showed that a high percentage of the early
arriving cells were bone marrow derived, but after the initial inflammation was gone, the number of marrow-originating
cells dropped off significantly for the non-bioactive (resorbable only) materials.
Point #2: Bone marrow cells are known to be some of the most potent regenerative cells in the body, and this study
proves that SIS attracts these cells to the site of tissue repair better than other resorbable materials.
Stem cells in the body are often characterized by their potency or their ability to adapt to specific conditions and turn into
functional cells of various types. To recapitulate a functional tissue after a surgical repair, recruiting the most adaptable
cells to the site would provide the most benefit. Because Surgisis is eventually resorbed by the host, many surgeons
compare it to other resorbable materials, such as Vicryl mesh. But resorption is only part of the smart-remodeling
process of Surgisis. This paper demonstrates that bone marrow cells recruited to the site by the SIS biomaterial persist
and differentiate into fibroblastic, endothelial, and even muscular phenotypes. This does not happen with resorbable
materials that do not remodel, yet this property can be conferred to them by the addition of intact ECMs like SIS.
Point #3: Collagen is a necessary structural component of SIS, but the non-collagen components of SIS are
responsible for the recruitment of specialized cells.
Collagen type I is the main structural protein in the animal kingdom. Extracellular matrix that is chemically stripped of its
bioactive components is essentially only type I collagen in a matrix form. In this study, type I collagen was also compared for
its ability to recruit bone marrow cells. Its response was virtually identical to the synthetic, resorbable PLGA material in that
the recruited marrow-derived cells were part of the early, transient inflammation and not part of the long-term response.
In a follow-up study, Zantop et al.1 showed in a tendon gap model that even a stripped, yet structurally intact collagen
matrix from the same animal did not recruit marrow cells long-term as observed in the SIS biomaterial. Both of these studies
implicate the non-collagen components of SIS as the reason that marrow-derived, highly-potent cells are recruited to and
persistent in the implant site.
1. J Orthop Res. 2006 Jun;24(6):1299-309
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Small intestinal submucosa does not promote Paiii tumor
growth in Lobund–Wistar rats.
Hodde JP, Suckow MA, Wolter WR, et al.
Cook Biotech Incorporated, 1425 Innovation Place, West Lafayette, Indiana, USA; and †Lobund Institute, University of Notre Dame, Notre Dame, Indiana
J Surg Res. 2004;120:189-94.
Abstract
Talking Points
Background: Site-specific remodeling and angiogenesis are two
• Tissue loss due to tumor
observations associated with the use of small intestinal submucosa
(SIS) as a tissue repair graft. Its angiogenic capacity has raised
questions concerning its effect on tumor growth and metastasis
in clinical tumor resection cases. The effect of SIS on the ability of
neoplastic (prostate adenocarcinoma) cells to establish, grow and
metastasize was examined in Lobund–Wistar (L-W) rats.
resection often creates a defect
that needs augmentation.
• Tissue repair biomaterials are
likely candidates for repairing
surgical defects but clinicians
Materials and methods: In one study, SIS, expanded
are concerned about what
polytetrafluoroethylene (ePTFE), or human cadaveric dermis was
effect these materials may
placed in a subcutaneous pocket on the flank of L-W rats and
immediately inoculated with PA-III cell suspension. Tumors were
allowed to establish and metastasize for 5 weeks prior to sacrifice. Rate
have on tumor growth and
metastasis.
of tumor growth, tumor weight, and frequency of lung metastases were
assessed. In a second study, SIS was placed in a resected tumor bed
• This study demonstrated that
and tumors were allowed to recur. Rate of tumor growth, tumor weight,
SIS and cadaveric dermis
and of lung metastases were assessed after 3 weeks.
did not enhance tumor
Results: ePTFE hastened the rate of formation of palpable tumors
compared to controls and other materials; cadaveric dermis and SIS
did not. No differences between materials were noted in final tumor
weight nor in the frequency of metastasis to the lungs. Following
surgical tumor resection, residual tumor cells led to recurrence of
same-site tumors in all animals, but in the defects augmented with SIS,
the tumors were significantly smaller than those which regrew in the
resected, unaugmented group.
Conclusions: This study demonstrates that SIS does not enhance
tumor establishment, growth, or metastasis in de novo tumors.
Furthermore, SIS appears to reduce the rate of tumor growth, but not
metastasis, when applied in direct contact with a residual tumor bed in
a rat model of prostate-related tumors.
Keywords: metastasis, prostate cancer, graft, angiogenesis, biomaterial.
growth or metastasis while
polytetrafluorethylene
(ePTFE) did.
Point #1: Tissue loss due to tumor resection often creates a defect that needs augmentation.
Removal of a solid tumor often leaves a void or a pocket that may result in the formation of a cyst or seroma.
Point #2: Tissue repair biomaterials are likely candidates for repairing surgical defects but clinicians are concerned
about what effect these materials may have on tumor growth and metastasis.
Repair of soft tissue defects with a biomaterial that would promote healthy tissue growth while not inducing regrowth
of tumor cells would be ideal. However, since some biomaterials retain their natural bioactive compounds such as
transforming growth factor-beta (TGF-_), and basic fibroblast growth factor (FGF-2), there has been concern that the use of
these materials in an area where residual tumor cells may exist would promote regrowth or metastasis of the tumor.
Point #3: This study demonstrated that SIS and cadaveric dermis did not enhance tumor growth or metastasis while
polytetrafluorethylene (ePTFE) did.
In this study the prostate adenocarcinoma cell line PAIII was utilized in a highly predictable animal model to determine
whether or not SIS would promote tumor recurrence and metastasis in comparison to ePTFE and cadaveric dermis.
Strikingly, in the group where SIS was implanted at the site of the tumor resection the tumors that recurred were remarkably
smaller than the control groups (sham operation or resection only) suggesting that SIS may contain factors that inhibit
the rate of tumor cell growth. Interestingly, ePTFE significantly increased the rate of primary tumor establishment when
compared to both SIS and cadaveric dermis.
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An investigation of the long-term bioactivity of
endogenous growth factor in oasis Wound Matrix.
Hodde JP, Ernst DMJ, Hiles MC.
Cook Biotech Incorporated, West Lafayette, Indiana, USA. [email protected]
J Wound Care. 2005;14(1):23-25.
Abstract
Talking Points
OBJECTIVE: To examine the retention and bioactivity of endogenous
• FGF-2 is retained in all six lots
FGF-2 after prolonged storage within a complex matrix. FGF-2 is
a growth factor found in Oasis® Wound Matrix, a purified collagen
wound-care product containing other endogenous components of the
extracellular matrix.
of SIS that was tested.
• SIS contains FGF-2 that is
maintained in its bioactive form.
METHOD: FGF-2 content was measured by ELISA. FGF-2 activity
was measured using an in vitro bioassay in rat pheochromocytoma
(PC12) cells.
RESULTS: FGF-2 content ranged from 15.3 ng/g to 84.3 ng/g. The
bioassay showed that the FGF-2 retained in the matrix was present in a
bioactive form able to cause differentiation of cells in culture.
CONCLUSION: The results demonstrate that wound-care products
can be developed to retain their bioactivity over time and that
inherently unstable purified growth factors are preserved if stored as
bound factors within their natural extracellular matrix. The results also
suggest that use of acellular matrices containing active growth factors
would have advantages in terms of simplicity and cost over purified
recombinant growth factor therapies.
Keywords: extracellular matrix, FGF-2, growth factor, bioactivity.
• The SIS process preserves
growth factors, likely through
binding to other components
of SIS.
Point #1: FGF-2 is retained in all six lots of SIS that was tested.
SIS is processed in such a way as to preserve many of the non-collagen components. In particular, growth factors are of
specific interest due to their role in the wound healing process. The authors of this study found that the endogenous FGF-2
previously reported in Oasis Wound Matrix is maintained in material that is stored for at least 24 months at room temperature. Specifically, the levels that were present in all six lots met the standard that is established through the USP monograph
for SIS Wound Matrix.1 These findings are important as the non-collagen components of SIS help attract cells and blood
vessel growth to repair the site.
1. U.S. Pharmacopeia. USP29-NF24. 2268-2270.
Point #2: SIS contains FGF-2 that is maintained in its bioactive form.
A bioactivity assay using rat pheochromochytoma (PC12) cell line shows that the FGF-2 present in all lots of Oasis Wound
Matrix tested is maintained in its bioactive form, even after at least 24 months of storage. This was illustrated by neurite
formation from the PC12 cells after stimulation with Oasis condition cell culture media. The neurite formation indicates
differentiation of the PC12 cells. These results suggest that the porcine FGF-2 contained in SIS products can help to coordinate the healing response noted after use even across species.
Point #3: The SIS process preserves growth factors, likely through binding to other components of SIS.
The process utilized to produce medical grade SIS was designed to retain as many of the non-collagen components of
SIS as possible, while providing the safety requirements that naturally derived materials require. In living tissues, growth
factors bind to extracellular matrix components to stabilize them and provide storage for the growth factors to be released
when needed.2,3 As the SIS process aims to maintain these extracellular matrix components, much of the inherent growth
factors have also been retained in bioactive forms. These bioactive growth factors likely help coordinate the remodeling
noted with the use of SIS for wound care or surgical procedures. The binding factors within SIS likely also help stabilize
growth factors released by the host cells after implantation of SIS, further helping guide and coordinate the healing and
remodeling process.
2. Middleton J, et al. Transcytosis and surface presentation of IL-8 by venular endothelial cells. Cell. 1997;91:385-395.
3. Zhou FY, et al. Heparin-dependent fibroblast growth factor activities: effects of defined heparin oligosaccharides. Eur J Cell Biol. 1997;73:71-80.
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Randomized clinical trial comparing oasis Wound Matrix
to Regranex Gel for diabetic ulcers.
Niezgoda JA, Van Gils CC, Frykberg RG.
Adv Skin Wound Care. 2005;18:258-266.
Abstract
Talking Points
OBJECTIVE: To compare healing rates at 12 weeks for full-thickness
diabetic foot ulcers treated with
Oasis®
Wound Matrix, an acellular
wound care product, versus Regranex® Gel.
DESIGN: Randomized, prospective, controlled multicenter trial at 9
outpatient wound care clinics.
SUBJECTS: A total of 73 patients with at least 1 diabetic foot ulcer were
entered into the trial and completed the protocol.
INTERVENTION: Patients were randomized to receive either Oasis
Wound Matrix (n = 37) or Regranex Gel (n = 36) and a secondary
dressing. Wounds were cleansed and debrided, if needed, at a
weekly clinic visit. Dressings were changed as needed. The maximum
treatment period for each patient was 12 weeks.
PRIMARY OUTCOME MEASURE: Incidence of healing in each group
at 12 weeks.
RESULTS: After 12 weeks of treatment, 18 (49%) Oasis-treated patients
had complete wound closure compared with 10 (28%) Regranextreated patients.
CONCLUSION: Although the sample size was not large enough to
demonstrate that the incidence of healing in the Oasis group was
statistically superior (P = .055), the study results showed that treatment
• This study shows that Oasis
Wound Matrix is as effective
as Regranex Gel in this patient
population. Regranex Gel
is a very expensive growth
factor (recombinant human
platelet-derived growth factor)
approved by the FDA to treat
chronic diabetic ulcers.
• At 12 weeks follow-up, 18
(49%) Oasis-treated patients
had complete wound closure
compared with 10 (28%)
Regranex-treated patients.
The associated p-value for
significance is P = 0.055.
• Type-2 diabetics represent
a patient population with
impaired wound-healing
characteristics, yet Oasis use
was able to help drive these
wounds toward closure.
with Oasis is as effective as Regranex in healing full-thickness diabetic
foot ulcers by 12 weeks.
• Oasis only needs to be applied
on a weekly basis to achieve
this level of wound closure,
whereas the Regranex Gel
needs to be applied daily. This
makes patient compliance more
likely. This suggests that Oasis
is able to provide sustained
release of signals needed to
restore epithelialization and
skin integrity.
Point #1: This study shows that Oasis Wound Matrix is as effective as Regranex Gel in this patient population.
Regranex Gel is a very expensive growth factor (recombinant human platelet-derived growth factor) approved by
the FDA to treat chronic diabetic ulcers.
SIS technology supplies the signals and the 3-dimensional matrix structure needed to effectively direct tissue remodeling.
This study shows that it is as effective as expensive pharmacologic treatments and purified growth factors (a common
signal). In surgery, where signals and structure are important to achieving the best outcome, Surgisis® provides both.
Point #2: At 12 weeks follow-up, 18 (49%) Oasis-treated patients had complete wound closure compared with 10
(28%) Regranex-treated patients. The associated p-value for significance is P = 0.055.
Even though this was a small patient population, wound closure rates in the Regranex arm were typical as compared to
other published literature.1,2 It is important to realize that this study was not powered to show the superiority of Oasis over
Regranex; it was only designed to show equivalence. This was easily shown in this patient population.
1. Wieman TJ, et al. Diabetes Care. 1998;21:822-827.
2. Marston WA, et al. Diabetes Care. 2003;26:1701-1705.
Point #3: Type-2 diabetics represent a patient population with impaired wound-healing characteristics, yet Oasis
use was able to help drive these wounds toward closure.
Type-2 diabetics account for most of the diabetic population in the United States. These patients often have other serious
health problems, such as nicotine addiction or obesity, which make their wounds, whether surgical or topical, very difficult
to treat effectively. Because Oasis is effective in this patient population, this study suggests that it can be effectively used in
patients who have many serious health problems. The results of this study can be used to illustrate that SIS Technology can
be effective in patients with diabetes and other health complications.
Point #4: Oasis only needs to be applied on a weekly basis to achieve this level of wound closure, whereas the
Regranex Gel needs to be applied daily.
That Oasis is as effective as Regranex with once-weekly application suggests that Oasis is able to provide sustained
release of signals needed to restore epithelialization and skin integrity, while Regranex cannot. Sustained release of
signals allows the matrix to help direct all stages of tissue repair following topical use, or in the case of Surgisis, following
surgical implantation.
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Effectiveness of an extracellular matrix graft (Oasis Wound Matrix)
in the treatment of chronic leg ulcers: a randomized clinical trial.
Mostow EN, Haraway GD, Dalsing M; OASIS Venus Ulcer Study Group.
J Vasc Surg. 2005;41:837-843.
Abstract
Talking Points
Background: Venous leg ulcers are a major cause of morbidity,
• Wound healing has four distinct
phases, and chronic wounds
get stalled in the process. This
study shows that Oasis ® Wound
Matrix (and the SIS Technology)
can help coordinate the body’s
healing process and move
difficult wounds beyond this
stalled state and to complete
closure.
economic loss, and decreased quality of life in affected patients.
Recently, biomaterials derived from natural tissue sources have been
used to stimulate wound closure. One such biomaterial obtained from
porcine small-intestine submucosa (SIS) has shown promise as an
effective treatment to manage full-thickness wounds. Our objective was
to compare the effectiveness of SIS wound matrix with compression vs
compression alone in healing chronic leg ulcers within 12 weeks.
Methods: This was a prospective, randomized, controlled multicenter
trial. Patients were 120 patients with at least 1 chronic leg ulcer. Patients
were randomly assigned to receive either weekly topical treatment of
SIS plus compression therapy (n = 62) or compression therapy alone
(n = 58). Ulcer size was determined at enrollment and weekly
throughout the treatment. Healing was assessed weekly for up to 12
weeks. Recurrence after 6 months was recorded. The primary outcome
measure was the proportion of ulcers healed in each group at 12 weeks.
Results: After 12 weeks of treatment, 55% of the wounds in the SIS
group were healed, as compared with 34% in the standard-care group
(P = .0196). None of the healed patients treated with SIS wound matrix
and seen for the 6-month follow-up experienced ulcer recurrence.
Conclusions: The SIS wound matrix, as an adjunct therapy,
significantly improves healing of chronic leg ulcers over compression
therapy alone.
• At 12 weeks follow-up, 34
(55%) Oasis-treated patients
had complete wound closure
compared with 20 (34%)
compression therapy alone
patients. The associated
p-value for significance is
P = 0.0196.
•Patients who had baseline
debridement followed by Oasis
treatment were four times more
likely to epithelialize than with
standard of care compression
therapy alone.
• Oasis only needs to be applied
on a weekly basis to achieve
this level of wound closure,
suggesting that Oasis is able
to provide a sustained benefit
to help restore epithelialization
and skin integrity.
Point #1: Wound healing has four distinct phases, and chronic wounds get stalled in the process. This study shows
that Oasis Wound Matrix (and the SIS Technology) can help coordinate the body’s healing process and move difficult
wounds beyond this stalled state and to complete closure.
Wounds (including surgical wounds) need proper nutrients and signals to heal. Chronic wounds get stuck in the
inflammatory stage and cannot progress to tissue remodeling.1 This study illustrates that the signals contained within the
SIS matrix stimulate wound closure as compared to compression dressings alone, and dramatically shows the effectiveness
that bioactive materials, such as Surgisis, can have in stimulating tissue repair and regeneration.
1. Waldrop J, Doughty D. Wound-healing physiology. In: Bryant R, ed. Acute and Chronic Wounds: Nursing Management. Minneapolis, MN: Mosby, Int.; 2000:17-39.
Point #2: At 12 weeks follow-up, 34 (55%) Oasis-treated patients had complete wound closure compared with 20
(34%) compression therapy alone patients. The associated p-value for significance is P = 0.0196.
Although a small patient population, wound closure rates in the standard of care arm were typical as compared to other
published literature. Closure rates in the Oasis arm were statistically significantly higher. Oasis Wound Matrix offers
significant improvement over standard of care alone in the treatment of venous ulcers.
Point #3: Patients who had baseline debridement followed by Oasis treatment were four times more likely to heal
than with standard of care compression therapy alone.
Baseline debridement allows the Oasis Wound Matrix to more effectively bond with the wound bed and achieves a healthy
blood flow in the area. This allows the signals and three-dimensional structure of the matrix the ability to more effectively
integrate with the wound bed, leading to closure. Intimate surface contact and a good blood supply are important factors
in achieving best outcomes when using any of the products based on the SIS technology.
Point #4: Oasis only needs to be applied on a weekly basis to achieve this level of wound closure, suggesting that
Oasis is able to provide a sustained benefit to help restore epithelialization and skin integrity.
Ease-of-application, low cost and the need for only once-weekly office visits make Oasis an effective time-saving and costsaving addition to standard-of-care. Slow degradation allows the matrix to influence all stages of tissue repair following
topical use, or in the case of Surgisis®, following surgical implantation.
Complete Remodeling
Long-term Strength
SIGNALS THE BODY
COMPLETE REMODELING
LONG-TERM STRENGTH
Signals the Body
LONG-TERM STRENGTH
Resistant to
Infection
COMPLETE REMODELING
SIGNALS THE BODY
HERNIA REPAIR
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Preliminary experience with new bioactive prosthetic
material for repair of hernia in infected fields.
Franklin ME Jr, Gonzalez JJ Jr, Michaelson RP, et al.
Texas Endosurgery Institute, 4242 E. Southcross, Suite 1, San Antonio, TX 78222, USA
Hernia. 2002;6(4):171-174.
Abstract
Talking Points
Surgisis® (Cook Surgical, Bloomington, Ind., USA) is a new four-ply
• During hernia repair,
bioactive, prosthetic mesh for hernia repair derived from porcine smallintestinal submucosa. It is a naturally occurring extracellular matrix
which is easily absorbed, supports early and abundant new vessel
growth, and serves as a template for the constructive remodeling of
prosthetic devices of various
compositions are commonly
used to reinforce weak
many tissues. As such, we believe that Surgisis mesh is ideal for use
musculature and decrease the
in contaminated or potentially contaminated fields in which ventral,
likelihood of recurrence.
incisional, or inguinal hernia repairs are required. From November
2000 through May 2002, 25 patients (11 male, 14 female) underwent
• The use of mesh (prosthetic
placement of Surgisis mesh for a variety of different hernia repairs. A
material) in contaminated
total of 25 hernia repairs were performed in our patient population.
Fourteen procedures (56%) were performed in a potentially
contaminated setting (i.e. with incarcerated/strangulated bowel
fields is often contraindicated;
however, because of its
within the hernia or coincident with a laparoscopic cholecystectomy/
greater resistance to infection
colectomy). Eleven repairs (44%) were performed in a grossly
in comparison to synthetic
contaminated field, including one in which an infected polypropylene
mesh, Surgisis may prove
mesh from a previous inguinal hernia repair was replaced with Surgisis
advantageous.
and one in which necrotic bowel was discovered within the hernial
sac. Median follow-up was 15 months with a range of 1-20 months. Of
the 25 total repairs, there was one wound infection complicated by
enterocutaneous fistula in a patient originally operated on for ischemic
• Surgisis embodies the benefits
of both nonabsorbable and
bowel. The fistula was in a location independent of the Surgisis mesh.
absorbable synthetic materials
There were no mesh-related complications or recurrent hernias in
– strength and decreased
our early postoperative follow-up period. Surgisis mesh appears to
infection, respectively.
be a promising new prosthetic material for hernia repair, especially in
contaminated or potentially contaminated fields. Obviously, long-term
follow-up is still required.
Keywords: herniorrhaphy, laparoscopic hernia repair, mesh repair,
Surgisis mesh, contaminated field.
Point #1: During hernia repair, prosthetic devices of various compositions are commonly used to reinforce weak
musculature and decrease the likelihood of recurrence.
A hernia occurs with the protrusion or rupture of a structure through the tissues surrounding it as a result of a soft tissue
defect (e.g., muscle weakness). Various types of prosthetic mesh materials are marketed for use in hernia repair procedures
as means of reinforcement. These primarily include absorbable and nonabsorbable synthetic mesh and naturally derived
biomaterials (such as Surgisis). All have their own risks and benefits. Synthetic mesh is traditionally categorized by pore
size and most are nonabsorbable. For some permanent (i.e., nonabsorbable) synthetics, the long-term strength declines
(resulting in recurrence) and infection may require removal. On the other hand, absorbable mesh, composed of polyglactin
or polyglycolic acid, are completely absorbed by the body with no incorporation or remodeling. While they pose a minimal
risk of infection, the lack of long-term strength typically results in hernia recurrence necessitating subsequent repair,
especially in high-stress areas such as the abdominal wall. Unlike synthetic mesh, SIS is a natural extracellular matrix that
facilitates tissue remodeling while being slowly incorporated into the body. As such, SIS provides not only mechanical
strength, but acts as a scaffold to guide tissue incorporation, creating a long-term, permanent repair comprised entirely of
host tissue.
Point #2: The use of mesh (prosthetic material) in contaminated fields is often contraindicated; however, because of
its greater resistance to infection in comparison to synthetic mesh, Surgisis may prove advantageous.
Because the infection and recurrence rate is low, SIS is becoming increasingly utilized in procedures, especially hernia,
in which the field may be potentially contaminated (e.g., incarcerated hernia) or grossly contaminated (e.g., presence of
infection or feces). This is significant as the more traditional methods of hernia repair are significantly more likely to result
in infection (permanent synthetic materials)1,2 or recurrence (absorbable synthetic materials).3 As SIS contains proteins and
regulatory factors that stimulate the body’s natural healing processes4,5, SIS acts as a scaffold for guided tissue growth.6
SIS becomes infiltrated with host cells, tissues, and blood vessels, in addition to becoming accessible to the host immune
system. At the same time that SIS is guiding the tissue remodeling, it is being incorporated into the host system such that no
device material permanently remains—reducing the likelihood of tissue erosion, late-term infection, and/or encapsulation.
When Surgisis is used subsequent surgical repairs may be conducted with minimal difficulty as only host tissue remains
following SIS incorporation. Here, Surgisis was successfully used within grossly contaminated and potentially contaminated
fields to correct ventral and inguinal hernias.
1. White TJ, et al. Am Surgeon 1998;64:276-280.
2. Leber GE, et al. Arch Surg 1998;133:378-382.
3. Dayton MT, et al. Arch Surg 1986;121:954-960.
4. Hodde JP. Endothelium 2001;8:11-24.
5. Hodde JP, Hiles MC. Biochemistry of Wound Healing 2001;13:195-201.
6. Hodde JP. Tissue Eng 2002;8:295-308.
Point #3: Surgisis embodies the benefits of both nonabsorbable and absorbable synthetic materials – strength and
decreased infection, respectively.
Previous studies have shown that the remodeled host tissue that replaces SIS attains or surpasses the strength of the native
tissue and retains that strength over time.10,11 This is important for hernia repair as the likelihood of hernia recurrence is thus
significantly lowered and remains lowered. This is unlike some synthetics which may provide for weak in-growth or initial
strength which dissipates over time. Similarly, though infection is inevitable to a degree with all devices and procedures, a
device which decreases that risk would be superior in comparison to others, especially in areas where infection is already
present.
10. Badylak SF, et al. J Surg Res 2001;99:282-287.
11. Clark KM, et al. J Surg Res 1996;60:107-114.
HERNIA REPAIR
FISTULA REPAIR
PEYRONIE’S REPAIR
DURAL REPAIR
PELVIC FLOOR REPAIR
Use of porcine small intestinal submucosa as a prosthetic
device for laparoscopic repair of hernias in contaminated
fields: 2-year follow-up.
Franklin ME Jr, Gonzalez JJ Jr, Glass JL.
Texas Endosurgery Institute, 4242 E. Southcross, Suite 1, San Antonio, TX 78222, USA
Hernia. 2002;6:171-174.
Abstract
Talking Points
BACKGROUND: Surgisis® is a new four- or eight-ply bioactive,
• Surgisis use prevents hernia
prosthetic mesh for hernia repair derived from porcine small intestinal
submucosa (SIS). It is a naturally occurring extracellular matrix, which is
easily absorbed, supports early and abundant new vessel growth, and
serves as a template for the constructive remodeling of many tissues.
recurrence in contaminated
fields.
As such, we believe that Surgisis mesh is ideal for use in contaminated
• Longer-term follow-up
or potentially contaminated fields in which ventral, incisional or
confirms that Surgisis
inguinal hernia repairs are required.
tolerates contaminated
environments well.
METHODS: From November 2000-May 2003, 53 patients (23 male,
30 female) underwent placement of Surgisis mesh for a variety of
different hernia repairs. A total of 58 hernia repairs were performed
in our patient population. Twenty procedures (34%) were performed
• Surgisis facilitates the
remodeling of host tissue to
in a potentially contaminated setting (i.e., with incarcerated/
provide a long-term repair
strangulated bowel within the hernia or coincident with a laparoscopic
without the use of a
cholecystectomy/colectomy). Thirteen repairs (22%) were performed
in a grossly contaminated field, including one in which an infected
polypropylene mesh from a previous inguinal hernia repair was
replaced with Surgisis mesh and one in which dead bowel was
discovered within the hernia sac. Median follow-up is 19 months
with a range of 1-30 months.
RESULTS: Of the 58 total repairs, there was one wound infection
complicated by enterocutaneous fistula in a patient originally operated
on for ischemic bowel. The fistula was in a location independent of
the Surgisis mesh. There have been no mesh-related complications or
recurrent hernias in our early postoperative follow-up period.
CONCLUSIONS: Surgisis mesh appears to be a promising new
prosthetic material for hernia repair and appears to function well,
especially in contaminated or potentially contaminated fields.
Obviously, long-term follow-up is still required.
Keywords: herniorrhaphy, laparoscopic hernia repair, mesh repair,
Surgisis mesh, contaminated field.
permanent material.
Point #1: Surgisis use prevents hernia recurrence in contaminated fields.
In this study, no mesh-related complications or hernia recurrences were reported during the 19-month follow-up period.
This is significant as some permanent (nonabsorbable) synthetic mesh displays initial strength which then declines over
time, placing the patient at increased risk for recurrence. Recurrence rates ranging from 0-24% have been reported in the
clinical literature,1,2 and rates as high as 71% are seen with contaminated fields in the pre-clinical literature.3 Additionally,
bacterial contamination (common with permanent synthetic meshes4,5) may require mesh removal6—again leaving the
patient vulnerable to recurrence which often necessitates further surgical intervention. On the other hand, absorbable
mesh, while completely absorbed by the body with no incorporation or remodeling, poses a minimal risk of infection
because of the lack of long-term device presence. However, this lack of long-term strength almost always results in hernia
recurrence7 necessitating subsequent repair, especially in high-stress areas such as the abdominal wall. Unlike the synthetic
mesh, SIS is a natural extracellular matrix that facilitates tissue remodeling while being slowly incorporated into the body. As
such, SIS provides not only mechanical strength, but acts as a scaffold to guide tissue incorporation, creating a long-term,
permanent repair. If the Surgisis does fail, resulting in hernia recurrence, subsequent surgical repairs may be conducted
with minimal difficulty as only host tissue remains. With permanent materials, however, tissue encapsulation may occur at
the site of repair, making removal difficult.
1. Ahmed M, et al. J Coll Physicians Surg Pak 2003;13:440-442.
2. Luijendijk RW, et al. N Engl J Med 2000;343:392-398.
3. Bleichrodt RP, et al. Surg Gynecol Obst 1993;176:18-24.
4. White TJ, et al. Am Surgeon 1998;64:276-280.
5. Leber GE, et al. Arch Surg 1998;133:378-382.
6. Robinson TN, et al. Surgical Endoscopy 2005;19:1556-1560.
7. Dayton MT, et al. Arch Surg 1986;121:954-960.
Point #2: Longer-term follow-up confirms that Surgisis tolerates contaminated environments well.
As stated above, because some synthetic mesh is more vulnerable to infection in fields with bacterial contamination and
require subsequent removal, Surgisis is becoming increasingly utilized in procedures, particularly hernia repair, in which the
field is potentially or grossly contaminated. Because Surgisis becomes infiltrated with host cells, tissues and blood vessels,
and thus is accessible to the host immune system, the risks of infection are minimized. Multiple reports have addressed
the ability of SIS to resist infection.8,9 In one,8 infrarenal aortic grafts composed of either SIS or ePTFE were challenged with
Staphylococcus aureus prior to implantation in dogs. After 30 days, all of the ePTFE grafts were infected as evidenced by
histology and/or bacterial culture, but none of the SIS grafts displayed infection. Here, Surgisis was successfully used within
contaminated and potentially contaminated fields to correct ventral and incisional hernias. This success was maintained
over the course of the study (avg. 19 months).
8. Badylak SF, et al. J Vasc Surg 1994;19:465-472.
9. Sarikaya A, et al. Tissue Eng 2002;8:63-71.
Point #3: Surgisis facilitates the remodeling of host tissue to provide a long-term repair without the use
of a permanent material.
If a device is to permanently repair damaged tissue, it must be able to support and sustain cell growth and proliferation.
What makes SIS material unique and advantageous over other more traditional, synthetic mesh is its ability to not only supply
mechanical support, but also to actively facilitate the remodeling of host tissue at the injury site. In this long-term follow-up
study, no reports of infection (related to the Surgisis implant site), mesh-related complications, or hernia recurrences were
reported. Four patients required subsequent laparoscopic procedures for unrelated reasons. During the procedure, the
initial repair site was inspected with minimal benign adhesions, complete incorporation of the mesh, and well-organized
in-growth of collagen found. Thus, SIS, on the whole embodies the characteristics to make it an ideal biomaterial for hernia
repair—acellular, non-permanent, provides mechanical integrity, and facilitates the growth of healthy, properly functioning
host tissue for a long-term repair.
HERNIA REPAIR
FISTULA REPAIR
PEYRONIE’S REPAIR
DURAL REPAIR
PELVIC FLOOR REPAIR
Short-term outcomes with small intestinal submucosa
for ventral abdominal hernia.
Helton WS, Fisichella PM, Berger R, et al.
Department of Surgery, University of Illinois at Chicago, Chicago, Illinois.
Arch Surg. 2005 Jun;140(6):549-60.
Abstract
Talking Points
HYPOTHESIS: A bioabsorbable tissue scaffold of porcine submucosal
• Surgisis is safe to use in clean
small intestine extracellular matrix (Surgisis® Gold™ [SIS]; Cook
Biotech Inc, West Lafayette, Ind) mesh is safe and effective for
ventral hernia repair.
DESIGN: Retrospective case series at a university teaching hospital.
and clean-contaminated hernia
repairs.
• Unlike many grafts, Surgisis
can be used in dirty wounds in
PATIENTS: Fifty-three consecutive patients having 8-ply SIS mesh
critically ill patients, but with
repair of ventral abdominal hernias.
increased complication rates.
MAIN OUTCOME MEASURES: Early complications, reoperation, hernia
recurrence, mesh or wound infection, or reaction. Outcomes reported
and compared on an intention-to-treat basis.
• Dirty wounds carry a risk of
significant complications for all
biologically derived grafts.
RESULTS: Patients were stratified by wound class: clean, cleancontaminated and contaminated, or dirty. Median follow-up
• Resorbable synthetics always
was 14 months (range, 2-29 months) during which there were
require additional surgeries,
22 complications (41%), 17 early reoperations (32%), 13 partial
while Surgisis may not.
dehiscences (21%), 6 mesh reactions (11%), and 9 recurrent hernias
(17%). Seven recurrent hernias (78%) in critically ill, patients with dirty
wounds had the SIS mesh removed owing to infection or reoperation.
In patients without SIS mesh removal or debridement, 1 (2.2%) of 44
developed a recurrent hernia at 6 months. Patients with dirty wounds
were more likely to need early reoperation (P<.001), develop a
complication (P<.01), partial wound dehiscence (P<.05), or recurrent
hernia (P<.01) compared with patients with clean wounds. Critically
ill patients were more likely to have hernia recurrence (P<.05), early
reoperation (P<.001), and postoperative complications (P<.05).
CONCLUSIONS: Eight-ply SIS mesh is safe in clean and cleancontaminated hernia repair with satisfactory short-term outcomes.
However, delayed wound infection, repeated operation, and mesh
debridement warrant cautious use of SIS mesh in critically ill patients
and those with dirty wounds.
Point #1: Surgisis is safe to use in clean and clean-contaminated hernia repairs.
Surgisis was used to repair clean or clean contaminated hernias in 35 total patients. Of those patients, only 2 had recurrent
hernia, one in a clean hernia in a patient with liver cancer and the other in a contaminated hernia that was included in the
clean contaminated data. These results illustrate that Surgisis works well for non-infected or minimally infected hernias.
Point #2: Unlike many grafts, Surgisis can be used in dirty wounds in critically ill patients, but with increased
complication rates.
Dirty wounds in critically ill patients are notoriously hard to treat. These hernias cannot be repaired with non-resorbable
synthetics due to the high potential of persistent infection which can lead to significant morbidity and usually results in need
for mesh removal. The use of resorbable synthetics, on the other hand, does not result in persistent infection, however once
the graft resorbs, the hernia recurs thus necessitating a repeat surgery.1 Surgisis was used in a total of 18 of these patients
and successfully repaired the hernia in 11 of these cases. While these results are by no means perfect, they are a significant
improvement over the use of synthetics.
1. Dayton MT, et al. Archiv of Surg. 1986;121:954-960.
Point #3: Dirty wounds carry a risk of significant complications for all biologically derived grafts.
In the presence of a high microbial contamination, synthetic grafts are not desirable for reasons stated in point 2. However,
in these very difficult to treat wounds, all biologically derived grafts can also run into problems. The authors of this paper
commented that they have used alternative biologically derived grafts as well. In their experience, these graft also suffered
from premature degradation in grossly contaminated hernias. The exact bacterial contaminants are likely very important
to overall graft survival, but little is known about which bacteria pose the greatest risk. In general, the authors recommend
leaving contaminated hernias open, potentially under use of a wound vac, to reduce the risk of a closed space infection
which is thought to accelerate biologically derived graft degradation.
Point #4: Resorbable synthetics always require additional surgeries, while Surgisis may not.
As non-resorbable synthetic grafts are contraindicated for use in contaminated fields, resorbable synthetics (such as Dexon
or Vicryl) have arisen as a temporary measure to repair the hernia while treating the infection.1 The authors comment that
the use of resorbable synthetics for hernia repair always requires a second operation once the graft has resorbed. This
is due to the fact that these grafts do not incorporate into functional host tissue.2 Surgisis has been shown to remodel
into host tissue creating a long-term functional repair without persistence.2 In this study, Surgisis was used to successfully
repair 11 out of 18 dirty wound hernias without requiring additional surgeries. Even in situations were repeat surgeries are
necessary, the operation does not require graft removal as Surgisis is replaced by host tissue. Thus, Surgisis is a very good
alternative to resorbable synthetics for grossly contaminated hernias.
2. Badylak SF, et al. Surg Res. 2001;99:282-287.
HERNIA REPAIR
FISTULA REPAIR
PEYRONIE’S REPAIR
DURAL REPAIR
PELVIC FLOOR REPAIR
Comparison of small-intestinal submucosa and expanded
polytetrafluoroethylene as a vascular conduit in the presence
of gram-positive contamination.
Shell DH IV, Croce MA, Cagiannos C, et al.
Department of Surgery, University of Tennessee Health Science Center, Memphis, Tennessee.
Ann Surg. 2005;241(6):995-1004.
Abstract
Talking Points
OBJECTIVE: As a vascular conduit, expanded polytetrafluoroethylene
• Infection at a graft site can
(ePTFE) is susceptible to graft infection with Gram-positive organisms.
result in inadequate repair.
Biomaterials, such as porcine small-intestinal submucosa (SIS), have
been successfully used clinically as tissue substitutes outside the
vascular arena.
SUMMARY BACKGROUND DATA: In the present study, we compared
a small-diameter conduit of SIS to ePTFE in the presence of Grampositive contamination to evaluate infection resistance, incorporation
and remodeling, morphometry, graft patency, and neointimal
hyperplasia (NH) development.
METHODS: Adult male mongrel pigs were randomized to receive
either SIS or ePTFE (3-cm length, 6-mm diameter) and further
randomized to 1 of 3 groups: Control (no graft inoculation),
Staphylococcus aureus, or mucin-producing S epidermidis (each
graft inoculation with 10 colonies/mL). Pressure measurements
were obtained proximal and distal to the graft to create the iliac/
aorta pressure ratio. Morphometric analysis of the neointima and
histopathologic examinations was performed. Other outcomes
included weekly WBC counts, graft incorporation, and quantitative
culture of explanted grafts.
RESULTS: Eighteen animals were randomized. All grafts were patent
throughout the 6-week study period. Infected SIS grafts had less NH
and little change in their iliac/aorta indices compared with infected
ePTFE grafts. Quantitative cultures at euthanasia demonstrated no
growth in either SIS group compared with 1.7 x 10(4) colonies for
ePTFE S aureus and 6 x 10(2) for ePTFE S epi (each P < 0.001). All SIS
grafts were incorporated. Histology demonstrated remodeling into
host artery with smooth muscle and capillary ingrowth in all SIS groups.
Scanning electron micrography illustrated smooth and complete
endothelialization of all SIS grafts.
CONCLUSIONS: Compared with ePTFE, SIS induces host tissue
remodeling, exhibits a decreased neointimal response to infection,
and is resistant to bacterial colonization. SIS may provide a superior
alternative to ePTFE as a vascular conduit for peripheral vascular
surgery.
• SIS grafts performed superior
to ePTFE in the presence of
infection.
Point #1: Infection at a graft site can result in inadequate repair.
Potential infection is a serious concern in all surgeries. This concern is exacerbated with the presence of a synthetic graft.
Synthetic grafts can provide safe-havens for bacterial growth resulting in persistent infections that can necessitate the
removal of the graft material. In this study, expanded polytetrafluoroethylene (ePTFE) grafts performed worse in situations
of deliberate infection, evidenced by elevated white blood cell counts, lower aorta-iliac pressure ratios, and more intimal
hyperplasia (scar formation) on the interior surface. These findings, while for the vasculature, have corollaries in any graft
repair.
Point #2: SIS grafts performed superior to ePTFE in the presence of infection.
The authors found that SIS performed equally in controls and in the presence of infection, whereas ePTFE grafts performed
worse in the presence of infection. This speaks to the utility of SIS in potentially contaminated fields. The authors found that
ePTFE grafts had biofilm formation that resulted in elevated white blood cell counts, delayed or no tissue attachment to
the exterior of the graft, and a decrease in graft functionality. In contrast, SIS grafts had robust remodeling characteristics
for controls and deliberate infection, including functional tissue ingrowth with the presence of capillaries and smooth
muscle cells. By allowing for host tissue ingrowth, the SIS is able to provide the necessary graft functions while the natural
host defenses can resolve the infection, which they did in this study. As SIS is eventually remodeled into host tissue, there
is no concern for long-term complications due to persistent infection. Thus, SIS can perform superiorly to synthetics in the
presence of infection.
HERNIA REPAIR
FISTULA REPAIR
PEYRONIE’S REPAIR
DURAL REPAIR
PELVIC FLOOR REPAIR
Efficacy of anal fistula plug in closure of cryptoglandular
fistulas: long-term follow-up.
Champagne BJ, O’Connor LM, Ferguson M, et al.
Dis Colon Rectum. 2006;49(12):1817-21.
Abstract
Talking Points
Hypothesis: The long-term efficacy of Surgisis® Anal Fistula Plug in
• A total of 46 patients with 55
closure of cryptoglandular anorectal fistulas was studied.
Methods: Patients with high cryptoglandular anorectal fistulas were
prospectively studied. Additional variables recorded were: number of
individual fistula tracts were
included in this series, and 85%
of the tracts were successfully
fistula tracts, and presence of setons. Under general anesthesia and
closed using Surgisis Anal
in prone jackknife position, patients underwent irrigation of the fistula
Fistula Plug.
tract by using a Surgisis Anal Fistula Plug, which was securely sutured
in place at the primary opening and tacked to the periphery of the
secondary opening.
Results: Forty-six patients were prospectively enrolled during a
two-year period. Follow-up was six months to two years (median,
12 months). At final follow-up, all fistula tracts had been successfully
• The reported results concern
longer term follow-up, at an
average of 18 months.
• There was no evidence of plug
closed in 38 patients, for an overall success rate of 83 percent. Seven
infection even though the plug
patients had multiple tracts, for a total of 55 fistula tracts in the
was placed in contaminated
series. Of the 55 individual tracts, 47 (85 percent) were closed at final
fields.
follow-up. Patients with one primary opening were most likely to have
successful closure by using the anal fistula plug, although this was not
significant. Successful closure was not correlated with the
presence of setons.
Conclusions: Long-term closure of cryptoglandular anorectal
fistula tracts using Surgisis Anal Fistula Plug is safe and successful
in 83 percent of patients and 85 percent of tracts.
Keywords: fistula-in-ano, fistulotomy, fibrin glue, Surgisis Anal
Fistula Plug.
Point #1: A total of 46 patients with 55 individual fistula tracts were included in this series, and 85% of the tracts
were successfully closed using Surgisis Anal Fistula Plug.
This study shows that the Surgisis Anal Fistula Plug can be successfully used to repair cryptoglandular anorectal fistulas
and is a promising new technology. Furthermore, a previous report using Surgisis Anal Fistula Plug secured with 2-0 vicryl
suture reported an 87% success rate compared to a 40% success rate using fibrin glue.1 The high closure rates are a result
of the ability of the Surgisis to remodel into host tissue, effectively closing the tract. An additional benefit for the use of
Surgisis Anal Fistula Plug was the ability to suture this material into the primary opening. This is not possible with fibrin glue,
as it tends to run out of the fistula tracts.
1. Johnson E., Gaw JU, Armstrong DN. Efficacy of anal fistula plug vs. fibrin glue in closure of anorectal fistula. Dis Colon Rectum. 2006;49:371-376.
Point #2: The reported results concern longer-term follow-up, at an average of 18 months.
Longer-term follow-up is necessary to assess the efficacy of the repair. The authors report on their success with using Surgisis
Anal Fistula Plug for an average of 18 months follow-up. In the literature, anorectal fistulas have a reported recurrence rate
of 54% and an incontinence rate of 35%.2 Thirty-six of the 46 patients (83%) involved in this study had successful closures,
47 of the 55 individual tracts (85%) closed at the final follow-up, and 8 of the 55 persisted. The most common failure
was early plug extrusion likely due to excessive patient activity or inadequate suturing. A closure of the common primary
opening resulted in the closure of the secondary, distal openings. The authors conclude that the Surgisis Anal Fistula Plug
would be optimal for use in deeper, complex fistulas rather than in shorter, simpler fistulas.
2. Garcia-Aguilar J., Davey CS, Le CT, Lowry AC, Rothenberger DA. Patient satisfaction after surgical treatment for fistula-in-ano. Dis Colon Rectum. 2000;43:1206-1212.
Point #3: There was no evidence of plug infection even though the plug was placed in contaminated fields.
Surgisis can be used in the presence of infection, or in known infected fields. Surgisis has been shown previously to be
resistant to clinical infections in contaminated abdominal hernia repair.3 The resistance to infection is contributed to the
ingrowth of host capillaries and immune competent cells within Surgisis during the initial and long-term remodeling
process. Surgisis is eventually completely replaced by the host tissue, thereby avoiding the risk of chronic infection that
can occur with synthetic material implantations. As the interior of the rectum or colon is a contaminated field, this infection
resistance makes Surgisis an ideal material for use in this area.
3. Franklin Jr. ME, Gonzalez Jr. JJ, Glass JL. Use of porcine small intestinal submucosa as a prosthetic device for laparoscopic repair of hernias in contaminated fields: 2-year follow-up. Hernia. 2004;8:186-189.
Complete Remodeling
Long-term Strength
SIGNALS THE BODY
COMPLETE REMODELING
LONG-TERM STRENGTH
Signals the Body
LONG-TERM STRENGTH
Complete
Remodeling
COMPLETE REMODELING
SIGNALS THE BODY
HERNIA REPAIR
FISTULA REPAIR
PEYRONIE’S REPAIR
DURAL REPAIR
PELVIC FLOOR REPAIR
Small intestinal submucosa for pubourethral sling suspension
for the treatment of stress incontinence: first histopathological
results in humans.
Wiedemann A, Otto M.
Department of Urology, Marienhospital Gelsenkirchen (AW), Gelsenkirchen and Institute of Pathology, Reference Center for Implant & Biomaterials Pathology (MO), Trier, Germany
J. Urol. 2004;172(1):215-8.
Abstract
Talking Points
Purpose: Small intestinal submucosa (SIS), a biomatrix of porcine
• The authors show histology
origin, is used in pubourethral sling operations for female urinary
stress incontinence, among other urological and surgical indications.
To our knowledge we report the first histopathological examination of
this biomatrix in human subjects.
that demonstrates that with
a mean follow-up of over
a year, there is no specific
tissue reaction associated
Materials and Methods: In a series of 15 patients with
with the implant, there is no
pubourethral sling procedures using SIS, 3 reoperations were
evidence of a foreign body
necessary because of recurrent urinary stress incontinence at a mean
reaction to the implant, there
of 12.7 months. Biopsies were taken from the implantation site of the
is no immunological response
SIS band under the vaginal mucosa. Several immunohistochemical
reactions were used to identify any inflammatory reaction.
Results: The biopsies under investigation showed nothing more than
to the implant, and there is
no evidence of any chronic
inflammation.
focal residues of the SIS implant without any evidence of a specific
tissue reaction. There were no changes that might point to a foreign
• After a mean of 12+ months,
body reaction. There was likewise no evidence of any significant
12/15 (80%) of the patients
immunological reaction and in particular no evidence of any chronic
remained continent.
inflammatory reaction.
Conclusions: The morphological findings point to outstandingly
good biocompatibility of SIS. During healing the material is
• The authors specifically
point to the “outstandingly
incorporated into the body without any foreign body or inflammatory
good biocompatibility
reaction. The results of the first histological investigation of SIS in
of SIS” and point out the
human subjects emphasize the special status of SIS among implant
“morphologically outstanding
materials.
biointegration without any
Keywords: urethra, urinary incontinence, stress, prostheses and
implants, intestine, small, swine
reaction of the implant or
peri-implant material”.
Point #1: The authors show histology that demonstrates that with a mean follow-up of over a year, there is no
specific tissue reaction associated with the implant, there is no evidence of a foreign body reaction to the implant,
there is no immunological response to the implant, and there is no evidence of any chronic inflammation.
What these biopsies show is what Cook has demonstrated in pre-clinical animal studies for several years—the nature of SIS
to undergo tissue remodeling and provide a means for site-specific tissue repair. Chronic inflammation of the implant area
and the graft material do not occur, there is no walling-off of the implant, no evidence of a foreign body response, and no
adverse immunological events. Of significant importance is the lack of an observable immune response, a finding that is
reassuring that the material does not cause a significant adverse tissue reaction leading to graft failure. The SIS material
effectively undergoes remodeling such that it appears like normal tissue over time. The paper shows that in this location
the graft site becomes populated with tissue fibroblasts and gradually results in the restoration of a highly organized
connective tissue structure that resembles healthy and strong connective tissue.
Point #2: After a mean of 12+ months, 12/15 (80%) of the patients remained continent.
Many surgeons are skeptical that biologic materials offer the permanence that synthetics do. The results of this study show
that significant success out to a year can be achieved with non-synthetic grafts, and lends additional support to other
studies showing that these results can be retained for at least 2 years following placement.1 These rates are very similar
to the rates of success reported with synthetic materials. The biopsies were obtained from the three failed slings, and the
authors emphasize that they believe the failures were due to a premature degradation of the suture material that was used
to hold the sling in place, a problem that is avoided with “tension-free” placement techniques.
1. Rutner AB, Levine SR, Schmaelzle JF. Processed porcine small intestine submucosa as a graft material for pubovaginal slings: Durability and results. Urol. 2003;62:805-809.
Point #3: The authors specifically point to the “outstandingly good biocompatibility of SIS” and point out the
“morphologically outstanding biointegration without any reaction of the implant or peri-implant material”.
Very few tissue biopsies of post-implant SIS have been published, so any data that can demonstrate the histology of SISremodeled tissue (especially in humans) is important. Biocompatibility is important because it demonstrates that chronic
inflammation and foreign body response are not seen surrounding the implant and that integration of the graft with the
body occurs in a process that does not set up chronic inflammation (in contrast to synthetic materials) or other adverse
responses.
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Treatment with bioscaffold enhances the fibril morphology
and the collagen composition of healing medial collateral
ligament in rabbits.
Woo SL, Takakura Y, Liang R, et al.
Musculoskeletal Research Center, Department of Bioengineering, University of Pittsburgh, Pittsburgh, Pennsylvania
Tissue Eng. 2006;12(1):159-166.
Abstract
Talking Points
Porcine small intestinal submucosa (SIS) was shown to be an effective
• Functional remodeling depends
bioscaffold in enhancing the mechanical properties of healing medial
largely on collagen fibril size.
collateral ligaments (MCL). The purpose of this study was to investigate
whether there are corresponding improvements in morphology and
tissue compositions.
Fourteen rabbits were equally divided into two groups. In the SIS-
• SIS augmentation resulted in
remodeled functional tissue
formation.
treated group, a 6 mm gap was surgically created in the right MCL and
a layer of SIS was sutured covering the gap. For the nontreated group,
• Materials that are bioactive
the gap-injured MCLs remained untreated. All the left MCLs were sham
will help the patient’s own
operated and used as controls.
At 12 weeks, the status of collagen types I and V was evaluated
repair mechanisms create a
functional repair.
with immunofluorescent staining. The collagen type V/I ratios were
obtained using SDS-PAGE. Collagen fibril diameters were calculated
from the transmission electron micrographs.
• By initiating functional tissue
regeneration, SIS can help
create a long-term repair even
The results revealed that in the SIS-treated group, the collagen fibers
were more regularly aligned as were the cell nuclei. The collagen fibril
diameters were 22.2% larger and the ratio of collagen type V/I was
28.4% lower than those for the nontreated group (p < 0.05).
These improvements in the morphological characteristics and
biochemical constituents of healing MCLs following SIS treatment are
the likely reasons for improved mechanical properties.
without long-term persistence.
Point #1: Functional remodeling depends largely on collagen fibril size.
Fibrillar collagen is the primary mechanical strength component for most tissues. For tissues where the main function is
mechanical strength, such as ligaments, tendons, and fascia, the status of the fibrillar collagen is of the upmost importance.
Larger collagen fibrils provide more mechanical strength. Scar tissue has smaller collagen fibrils that make it much weaker
than native or remodeled tissue. In this study, using SIS to augment a ligament defect resulted in larger fibril diameters at
12 weeks, resulting in stronger tissue formation than the non-augmented group.
Point #2: SIS augmentation resulted in remodeled functional tissue formation.
Functionally remodeled tissues that more closely resemble the native tissues will provide more strength than scar
tissue. In this study, the authors found that SIS augmentation resulted in larger collagen fibrils and a lower collagen
type V/I ratio, both strong indicators of functional tissue remodeling. This indicates that SIS can help the host repair
the site with functionally remodeled tissue, not simply scar tissue.
Point #3: Materials that are bioactive will help the patient’s own repair mechanisms create a functional repair.
SIS is a bioactive material that can be used for soft-tissue reinforcement and repair. While SIS does not include cells, it
does include collagen, for immediate strength and scaffolding, as well as bioactive non-collagen components including
glycoproteins, proteoglycans, glycosaminoglycans and growth factors. The components of SIS help to recruit the appropriate
host cells to the place of injury and remodel the SIS.1,2 As a scaffold, SIS gives the cells a place to migrate while providing
the necessary short-term mechanical strength. But SIS is more than just a scaffold, it also contains the signals necessary to
jump start the repair and remodeling processes. The authors of this study found that SIS was able to direct the appropriate
host cells to the site and initiate the replacement of the SIS with remodeled, functional tissue.
1. J Cell Biochem. 1997;67:478-491.
2. J Biomater Sci Polymer Edn. 2001;12:1267-1279.
Point #4: By initiating functional tissue regeneration, SIS can help create a long-term repair even without long-term
persistence.
With any surgery, long-term positive outcome is the goal. As SIS is resorbed by the host, the long-term repair must come
from the remodeled host tissue. The authors for this study found that after twelve weeks, the SIS augmented ligaments
had a more functional repair than non-augmented ligaments. At this time point, the SIS had been fully resorbed, indicating
that the repair was host tissue. The same authors followed this twelve week study with a 26 week study, where they found
that the SIS augmented group had significantly higher strength and larger fibrils even out to this longer time point.3 These
results indicate that a long-term functional repair can be created with the use of SIS even after the SIS has been resorbed.
3. J Orthop Res. 2006 Apr;24:811-819.
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Histologic results 1 year after bioprosthetic repair of
paraesophageal hernia in a canine model.
Desai KM, Diaz S, Dorward IG, et al.
Department of Surgery and Institute for Minimally Invasive Surgery, Washington University School of Medicine, St. Louis, MO, USA and Department of Surgery,
Northwestern University, Chicago, IL, USA
Surg Endosc. 2006;20(11):1693-7.
Abstract
Talking Points
Background: The use of prosthetic materials for the repair of
• The use of synthetic prosthetic
paraesophageal hiatal hernia (PEH) may lead to esophageal stricture
and perforation. High recurrence rates after primary repair have led
surgeons to explore other options, including various bioprostheses.
However, the long-term effects of these newer materials when placed
mesh materials to repair
paraesophageal hiatal hernias
has been shown to be effective
at the esophageal hiatus are unknown. This study assessed the
in preventing recurrence of
anatomic and histologic characteristics 1 year after PEH repair using
hernias but sometimes leads
a U-shaped configuration of commercially available small intestinal
to esophageal stricture,
submucosa (SIS) mesh in a canine model.
perforation and erosion of the
Methods: Six dogs underwent laparoscopic PEH repair with SIS
mesh 4 weeks after thoracoscopic creation of PEH. When the six dogs
were sacrificed 12 months later, endoscopy and barium X-ray were
performed, and biopsies of the esophagus and crura were obtained.
mesh into the esophagus.
• The use of a bioscaffold such
as small intestinal submucosa
(SIS) mesh has been reported,
Results: The mean weight of the dogs 1 year after surgery was
but the long-term outcome had
identical to their entry weight. No dog had gross dysphagia, evidence
not previously been assessed.
of esophageal stricture, or reherniation. At sacrifice, the biomaterial
was not identifiable grossly. Biopsies of the hiatal region showed
fibrosis as well as muscle fiber proliferation and regeneration. No dog
had erosion of the mesh into the esophagus.
• This long-term study assessed
the anatomic and histologic
characteristics 1 year after PEH
Conclusions: This reproducible canine model of PEH formation
repair with SIS mesh, which is
and repair did not result in erosion of SIS mesh into the esophagus
conservatively equivalent to
or in stricture formation. Native muscle ingrowth was noted 1 year
more than 5 years in humans.
after placement of the biomaterial. According to the findings, SIS may
provide a scaffold for ingrowth of crural muscle and a durable repair of
PEH over the long term.
Keywords: laparoscopy, paraesophageal hernia, small intestinal submucosa
Point #1: The use of synthetic prosthetic mesh materials to repair paraesophageal hiatal hernias has been shown
to be effective in preventing recurrence of hernias but sometimes leads to esophageal stricture, perforation and
erosion of the mesh into the esophagus.
When large hiatal hernias are repaired with simple primary crural closures, the failure rate exceeds 40% requiring repeat
surgery and risk to the patient.1 Therefore, doctors have used synthetic mesh such as polypropylene or PTFE to prevent
recurrence. However, many physicians don’t use this material because of its propensity to erode over time and migrate to
surrounding tissue.2
1. Hashemi M, et al. Laparoscopic repair of large type III hiatal hernia: objective follow-up reveals high recurrence rats. J Am Coll Surg. 2000;190:553-560.
2. Schneider R, et al. Marlex mesh in repair of a diaphragmatic defect later eroding into the distal esophagus and stomach. Am Surg. 1999:45:337-339.
Point #2: The use of a bioscaffold such as small intestinal submucosa (SIS) mesh has been reported, but the longterm outcome had not previously been assessed.
Several clinical studies3-5 and this pre-clinical study have shown that SIS reinforces the hiatal closure, reduces the recurrence
rates, and promotes the regrowth of skeletal muscle without the erosion and migration that is reported with the use of
synthetics.
3. Oelshlager BK, et al. The use of small intestine submucosa in the repair of paraesophageal hernias: initial observations of a new technique. Am J Surg. 2003;186:4-8.
4. Holcomb III GW, et al. Laparoscopic patch repair of diaphragmatic hernias with Surgisis. J Ped Surg. 2005;40:E1-E5.
5. Grethel EJ, et al. Prosthetic patches for congenital diaphragmatic hernia repair: Surgisis vs. Gore-Tex. J Ped Surg. 2006;41:29-33.
Point #3: This long-term study assessed the anatomic and histologic characteristics 1 year after PEH repair with SIS
mesh, which is conservatively equivalent to more than 5 years in humans.
This study found the SIS functioned well as a buttress for hiatal hernia repair, provided a scaffold for native ingrowth of
connective tissue and skeletal muscle without creating stricture or reherniation. Moreover, after one year gross histological
examination revealed no biomaterial but the presence of mature fibrovascular tissue and significant muscle fiber proliferation
leading the authors to conclude that SIS is a safe alternative to synthetic mesh for repair of paraesophageal hernia.
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Biological prothesis reduces recurrence after laparoscopic
paraesophageal hernia repair: a multicenter, prospective,
randomized trial.
Oelschlager BK, Pellegrini CA, Hunter J, et al.
Ann Surg. 2006;244:481–490.
Abstract
Talking Points
Objective: Laparoscopic paraesophageal hernia repair (LPEHR) is
• LPEHR is associated with a high
associated with a high recurrence rate. Repair with synthetic mesh
lowers recurrence but can cause dysphagia and visceral erosions. This
trial was designed to study the value of a biologic prosthesis, small
intestinal submucosa (SIS), in LPEHR.
rate of recurrence. This study
showed that a Surgisis ® ES™
buttress used to reinforce the
crura significantly reduced the
Methods: Patients undergoing LPEHR (n = 108) at 4 institutions
incidence of hernia recurrence
were randomized to primary repair - 1° (n = 57) or primary repair
6 months after operation.
buttressed with SIS (n = 51) using a standardized technique. The
primary outcome measure was evidence of recurrent hernia (≥ 2 cm)
on UGI, read by a study radiologist blinded to the randomization
status, 6 months after operation.
• At 6 months follow-up, 4 (9%)
Surgisis-treated patients had
recurrence of a hernia compared
Results: At 6 months, 99 (93%) patients completed clinical
with 12 (24%) of patients that
symptomatic follow-up and 95 (90%) patients had an UGI. The groups
did not have reinforcement.
had similar clinical presentations (symptom profile, quality of life,
The associated p-value for
type and size of hernia, esophageal length, and BMI). Operative times
significance is P = 0.04.
(SIS 202 minutes vs. 1° 183 minutes, P = 0.15) and perioperative
complications did not differ. There were no operations for recurrent
hernia nor mesh-related complications. At 6 months, 4 patients (9%)
developed a recurrent hernia ≥ 2 cm in the SIS group and 12 patients
• The placement of Surgisis was
not associated with increase
(24%) in the 1° group (P = 0.04). Both groups experienced a significant
in heartburn, regurgitation,
reduction in all measured symptoms (heartburn, regurgitation,
dysphagia, chest pain, early
dysphagia, chest pain, early satiety, and postprandial pain) and
satiety, or postprandial pain
improved QOL (SF-36) after operation. There was no difference
as compared to the non-
between groups in either pre-or postoperative symptom severity.
reinforced group.
Patients with a recurrent hernia had more chest pain (2.7 vs. 1.0,
P = 0.03) and early satiety (2.8 vs. 1.3, P = 0.02) and worse physical
functioning (63 vs. 72, P = 0.03 per SF-36).
• Procedure time was not
different between groups. On
Conclusions: Adding a biologic prosthesis during LPEHR reduces
follow-up, patients without
the likelihood of recurrence at 6 months, without mesh-related
recurrence had less chest pain
complications or side effects.
and better physical functioning
than those patients who
experienced hernia recurrence.
Point #1: LPEHR is associated with a high rate of recurrence. This study showed that a Surgisis ES buttress used to
reinforce the crura significantly reduced the incidence of hernia recurrence 6 months after operation.
Any procedure that reduces the possibility of a second surgical procedure holds advantages for both the health care
system (in terms of reduced resources and associated costs), for the patient (in terms of less morbidity), and for society (in
terms of less time off work).
Point #2: At 6 months follow-up, 4 (9%) Surgisis-treated patients had recurrence of a hernia compared with 12
(24%) of patients that did not have reinforcement. The associated p-value for significance is P = 0.04.
Buttressing the crura with Surgisis ES significantly reduced the rate of hernia recurrence. It is well-established that the
traditional procedure is associated with high rates of recurrent problems. A Surgisis buttress is able to reduce recurrence
significantly in short-term follow-up, without erosion or increased complications.
Point #3: The placement of Surgisis was not associated with increase in heartburn, regurgitation, dysphagia, chest
pain, early satiety or postprandial pain as compared to the nonreinforced group.
An improved quality of life following surgery is important for any patient and makes the patient a better-functioning person
in society. Important for this study is that the less recurrence in the Surgisis group means that fewer patients treated with
Surgisis experienced declining quality of life.
Point #4: Procedure time was not different between groups. On follow-up, patients without recurrence had less
chest pain and better physical functioning than those patients who experienced hernia recurrence.
While some may argue about the added cost of the procedure, time in the operating room is not increased when
Surgisis is placed. More importantly, this study showed that patients who did not have a recurrence of hernia in the post
operative period were in better physical health and had less chest pain than patients who had recurrence. The benefit of
reducing the rate of recurrent hernia leads to a better quality of life.
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Use of a biodegradable patch for reconstruction of large
thoracic cage defects in growing children.
Smith MD, Campbell RM.
Department of Orthopedics, University of Texas Health Science Center and Christus Santa Rosa Children’s Hospital, San Antonio, TX 78229, USA
J Pediatr Surg. 2006;41(1):46-9.
Abstract
Talking Points
BACKGROUND/PURPOSE: At our institution, procedures were
• Prior to 2002, procedures
developed to enlarge and stabilize the thoracic cavity of children born
with severe-enough abnormalities of the thoracic cage as to result in
lack of normal lung growth and function. In addition to the device known
as the vertical expandable prosthetic titanium rib (VEPTR), some type
to enlarge and stabilize the
thoracic cavity of children
born with severe abnormalities
of patch material was needed to cover large congenital defects of the
to the thoracic cage used
chest cage owing to rib absence or to cover defects created because of
synthetic pliable patches for
the expansion process. Initially, synthetic material, polytetrafluorethylene
soft tissue coverage. Over time,
(Gore-Tex®, WL Gore and Associates, Flagstaff, Ariz) was used, but this
these materials needed to
proved itself to be restrictive over time and required removal. Thus, a
nonsynthetic biodegradable patch material was adopted for coverage
of the defects (Surgisis, Cook, Bloomington, Ind).
be removed.
• 26 children were implanted
METHODS: From October 2001 through October 2004, 26 growing
with Surgisis ® over a 3-year
children undergoing thoracic cage reconstruction received the
period of time. None of the
biodegradable extracellular matrix patch derived from porcine SIS
children required removal of
(Cook). A patch was deemed necessary if any one of the following
the product.
conditions was obtained: (a) herniation of the lung was likely; (b) chest
wall musculature was significantly diminished; (c) injury to the lung was
likely at reoperation; (d) the defect was greater than 2 x 2 cm.
• Surgisis is a superior alternative
for use in repair of the chest
RESULTS: During the follow-up period, 41 months thus far, each of the
wall in growing children with
26 children has undergone routine, scheduled expansions or change-
severe thoracic cage defects.
out procedures every 6 months. The SIS has not required removal for
any reason and has not restricted growth of the thoracic cage.
CONCLUSIONS: Compared with synthetic soft tissue patch material,
the nonsynthetic, biodegradable soft tissue patch (SIS) has proven to
be a superior alternative, thus far, to others for use in our population of
patients for reconstruction of the thoracic cage in the growing child.
Point #1: Prior to 2002, procedures to enlarge and stabilize the thoracic cavity of children born with severe
abnormalities to the thoracic cage used synthetic pliable patches for soft tissue coverage. Over time, these materials
needed to be removed.
Synthetic materials, such as Gore-Tex, have previously been used to enlarge and stabilize the thoracic cavity of growing
children. As the authors here note by experience, these materials often are removed as the child grows because the material
becomes too restrictive, since it does not grow with the child, or it becomes infected. An ideal surgical material would allow
for growth of the child without necessitating repeat surgeries. Thus the authors sought to use a resorbable, remodelable
biomaterial (Surgisis) for this study.
Point #2: 26 children were implanted with Surgisis over a 3-year period of time. None of the children required
removal of the product.
Surgisis performs a long-term repair by eliciting the host to functionally remodel the repair site into host tissue. As such,
the newly formed host tissue can grow with the patient. Surgisis was found to be successful in the repair of the thoracic
cage in these children. The only complication noted was occurrences of infection that resolved quickly in all but one of the
patients. Histological evaluation of the graft site from that patient showed no inflammation from the first episode, while
histological evaluation of the second episode showed that the Surgisis had remodeled into skeletal muscle with no fibrosis,
inflammation or atrophy, once again supporting the fact that Surgisis remodels into functional tissue. None of the patients
required removal of the Surgisis as would have been necessary in traditional synthetic biomaterial-assisted repair.
Point #3: Surgisis is a superior alternative for use in repair of the chest wall in growing children with severe
thoracic cage defects.
The use of Surgisis provides a durable repair of the chest wall that appears to grow with the child as the biannual thoracic
cage repair procedures are performed. As stated in point #2, histological evaluation of the repair suggested that the material
remodels over time which “grows” with the developing child. These results show that Surgisis should be considered as an
attractive alternative to synthetic materials for use in growing children for soft-tissue repair or reconstruction.
Complete Remodeling
Long-term Strength
SIGNALS THE BODY
COMPLETE REMODELING
LONG-TERM STRENGTH
Signals the Body
LONG-TERM STRENGTH
Long-term
Strength
COMPLETE REMODELING
SIGNALS THE BODY
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Strength over time of a resorbable bioscaffold for
body wall repair in a dog model.
Badylak S, Kokini K, Tullius B, Whitson B.
Department of Bimedical Engineering and Department of Mechanical Engineering, Purdue University, West Lafayette, Indiana 47907.
J Surg Res. 2001;99(2):282-7.
Abstract
Talking Points
The change in strength over time of a biomaterial derived from the
• SIS was remodeled into a tissue
small intestinal submucosa (SIS) was determined in a dog model of
body wall repair. Full-thickness body wall defects measuring 8 x 12 cm
were surgically created and then repaired with a multilaminate eightlayer form of SIS in 40 dogs.
with necessary mechanical
strength.
• For biodesigned materials,
Five dogs were sacrificed at each of the following time points:
the degradation has to be
1 day, 4 days, 7 days, 10 days, and 1, 3, 6, and 24 months. Ball burst
balanced with remodeling.
tests that measured biaxial ultimate load-bearing capability were
performed on the device prior to implantation and on the device/
implant site at the time of sacrifice. The strength of the device at the
time of implant was approximately 73 +/- 12 pounds. The strength
of the implant site diminished to 40 +/- 18 pounds at 10 days, and
then progressively increased to a value of 156 +/- 26 pounds at 24
• By initiating functional tissue
regeneration, SIS can help
create a long-term repair even
without long-term persistence.
months (P < 0.05). The clinical utility of a degradable biomaterial
such as SIS depends on a balance between the rate of degradation
and the rate of host remodeling.
Naturally occurring extracellular matrix scaffolds such as SIS show
rapid degradation with associated and subsequent remodeling to a
tissue with strength that exceeds that of the native tissue when used as
a body wall repair device.
• It is possible for SIS to remodel
into tissue that is stronger than
the host’s original native tissue.
Point #1: SIS was remodeled into a tissue with necessary mechanical strength.
Implanted SIS works by initiating the host to repair the tissue with the appropriate cells. The authors of this study found that
SIS was remodeled quickly and provided the mechanical strength necessary for the repair at all time points. The strength
of the repair at all time points was stronger than the native dog body wall, even long after the SIS was resorbed.
Point #2: For biodesigned materials, the degradation has to be balanced with remodeling.
Biodegradable materials used for functional repair must be engineered to provide the necessary strength for the repair at
all time points. As the material is degraded by the body, its strength will decrease. The new host tissue must have the ability
to provide the strength necessary to balance out the decrease in the graft strength. SIS promotes functional tissue ingrowth
and remodeling even as it is being degraded by the host. This allows for the new host tissue to provide the medium- and
long-term strength necessary for the repair. SIS-based products are engineered to allow for the degradation and to initiate
the reconstruction quickly to continuously provide adequate strength for the repair.
Point #3: By initiating functional tissue regeneration, SIS can help create a long-term repair even without long-term
persistence.
SIS is an extracellular matrix that is meant to perform two major functions in the intestine: mechanical strength and support
for the mucosal turnover. As such, SIS contains high levels of collagen, but also non-collagen components that support
continual tissue growth. SIS is minimally processed to retain these non-collagen components. When used for tissue repair,
SIS provides the short-term mechanical strength through the natural collagen scaffold while providing an environment
that initiates and directs host tissue ingrowth through the non-collagen components. This allows the host to remodel the
SIS graft quickly into functional tissue. This functional tissue provides the long-term strength necessary for the repair. In
this study, the authors found that SIS repairs of a dog body wall defect were substantially strong out to two years; in fact,
the repair gains in strength over the original graft. Thus, a long-term repair is provided without concerns over long-term
complications such as erosion.
Point #4: It is possible for SIS to remodel into tissue that is stronger than the host’s original native tissue.
There is a concern for many surgical groups that the reason that patients present with a hernia or other soft tissue failure is
due to insufficient collagen formation. As SIS is remodeled with the patient’s tissue, the concern is that the new tissue will
be as deficient as the old tissue. This study is a hallmark in illustrating that the SIS can stimulate the host to remodel the area
with tissue that is actually stronger than the old, native tissue. At two years after surgery, the resulting repair was multiple
times stronger than the initial native body wall. This suggests that SIS repairs can be stronger than the host’s original tissues
and thus less likely to fail.
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Processed porcine small intestine submucosa as a graft
material for pubovaginal slings: durability and results.
Rutner AB, Levine SR, Schmaelzle JF.
Urology. 2003;62(5):805-9.
Abstract
Talking Points
Objectives: To describe our surgical technique and results with
• Complications associated
with synthetic slings, such as
erosion, infection, and wallingoff, were not seen following
placement of the SIS sling in
this series of 152 patients.
The use of a biologic sling
also prevents the morbidity
associated with harvesting
autologous tissues.
implantation of processed porcine small intestine submucosa (SIS)
as a pubovaginal sling in 152 consecutive female patients with stress
urinary incontinence (SUI).
Method: Processed SIS is a biocompatible, acellular, collagen matrix.
SIS attracts local host cells to infiltrate and replace its substance. Our
procedure uses bone screws to anchor the sling to the pubis. Patients
were followed up closely after surgery to evaluate cure rates, side
effects, and complications.
Results: Of 152 patients, 142 (93.4%) were relieved of their SUI
during the 4-year series. Three additional patients had marked
improvement. Seven patients (4.6%) did not have satisfactory
continence after the initial surgery. SUI recurred in 5 of the 7 patients
with failure within 3 months of surgery. The other two failures
occurred at 9 and 11 months after surgery. Of the 152 patients, 77
(50.7%) had varying degrees of urgency/frequency preoperatively.
Although relieved of SUI postoperatively, most of these patients
continued to use medication for urgency. Patients undergoing simple
sling procedures were discharged from the hospital the day after
surgery and were catheter free by the next day. One required selfcatheterization for 3 days and another a Foley catheter for 5 days.
Patients undergoing pubovaginal sling placement and additional
pelvic procedures were hospitalized for 2 to 3 days with a catheter
in place during that time. Sling infection, erosion or rejection did not
develop in any case during the 4 years of this series.
Conclusions: Processed SIS is strong, durable, biocompatible,
infection resistant, and gradually replaced by host tissues.
• With a median follow-up of
2.3 years (range 4-48 months),
142/152 women (93.4%) were
completely relieved of their
stress urinary incontinence,
and an additional 3 women
(2%) exhibited marked
improvement. Five of the 7
patients who were not cured
experienced recurrence of their
symptoms within 3 months of
surgery.
• To minimize the risk of
infection, the SIS should be
rehydrated in an antibiotic
solution, patients should be
prepped immediately prior to
sling placement, and liberal
use of peri-and postoperative
antibiotics that include
anaerobic coverage should be
encouraged.
• Although this paper uses a
sling that has been secured to
the pubis with bone anchors,
a tension-free SIS sling is
available and has shown similar
success rates with a median of
2-years follow-up. 1
1 Jones JS, et al. British J of Urol. 2005;96:103-106
Point #1: Complications associated with synthetic slings, such as erosion, infection, and walling-off, were not seen
following placement of the SIS sling in this series of 152 patients. The use of a biologic sling also prevents the
morbidity associated with harvesting autologous tissues.
Minimizing the risks of long-term complications should be the goal of every surgical product and procedure. While serious
complications associated with synthetic slings are rare, they still exist. Many of these problems can be avoided with the
use of a non-synthetic sling. Erosion, chronic inflammation, and the increase in risk of late-term infection as a result of a
permanent synthetic material in the abdomen are avoided when biologic graft materials are utilized. Additionally, the
biologic sling made from porcine tissue does not require the harvesting of autologous fascia, a surgical procedure that is
associated with increased operative time and costs and can cause significant pain.2,3
2. Wadie BS, et al. J Urol. 2005;174:990-993.
3. Infect Urol. 1999;12:99-103.
Point #2: With a median follow-up of 2.3 years (range 4-48 months), 142/152 women (93.4%) were completely
relieved of their stress urinary incontinence, and an additional 3 women (2%) exhibited marked improvement. Five
of the 7 patients who were not cured experienced recurrence of their symptoms within 3 months of surgery.
Many surgeons are skeptical that biologic materials offer the permanence of repair that synthetics do. The results of this
study show that significant success beyond two years can be achieved with non-synthetic grafts and supports other work.4
These rates are very similar to the rates of success reported with synthetic materials.5, 6 Additionally, it is important to point
out that when success is not achieved, it appears that the recurrences occur within a few months of placement and do not
become more frequent with time.
4. Wiedemann A, Otto M. J Urol. 2004;172:215-218.
5. Juma S, Brito CG. Neurourol Urodyn. 2007;26:37-41.
6. Morey AF, et al. J Urol. 2006;175:1014-1017.
Point #3: To minimize the risk of infection, the SIS should be rehydrated in an antibiotic solution, patients should be
prepped immediately prior to sling placement, and liberal use of peri-operative and postoperative antibiotics that
include anaerobic coverage should be encouraged.
Strict pre-operative patient prep, the use of pre-operative, peri-operative, and postoperative antibiotics, and pristine
placement technique can minimize the risk of infection. Many incidents of postoperative inflammation that have been
reported in the literature have been associated with anaerobic bacterial colonization,7, 8 suggesting that a course of
prophylactic antibiotics with anaerobic coverage may be beneficial in minimizing the risk of postoperative complications.
7. Persson J, et al. Obstet Gynecol. 2002;99:629-634.
8. National Nosocomial Infections Suveillance (NNIS) System Report, data summary from January 1992 through June 2003, issued August 2003. Am J Infect control. 2003;31:481-498.
Point #4: Although this paper uses a sling that has been secured to the pubis with bone anchors, a tension-free SIS
sling is available and has shown similar success rates with a median of 2-years follow-up.1
These 2 papers demonstrate similar success rates out to 2 years as 79% (27 of 34) of the patients in Jones et al. were
continent at follow-up. This is important because placement techniques were different, indicating that the sling can be
placed with bone anchors to hold it in place, or it can be placed in tension-free fashion without anchoring. The choice of
placement technique can be left to the surgeon.
1. Jones JS, et al. British J Urol. 2005;96:103-106.
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Laparoscopic repair of inguinal hernia using
Surgisis mesh and fibrin sealant.
Fine AP.
JSLS. 2006;10:461-465.
Abstract
Talking Points
Objective: We tested the hypothesis that laparoscopic inguinal
• Chronic pain following inguinal
herniorrhaphy using Surgisis® mesh secured with fibrin sealant is an
effective long-term treatment for repair of inguinal hernia. This case
series involved 38 adult patients with 51 inguinal hernias treated in a
primary care center.
Methods: Between December 2002 and May 2005, 38 patients
hernia repair can be caused
by insufficient fixation and
material characteristics.
• Laparoscopic inguinal
with 45 primary and 6 recurrent inguinal hernias were treated with
hernia repair using Surgisis ®
laparoscopic repair by the total extra-peritoneal mesh placement
IHM™ mesh secured with
(TEP) technique using Surgisis mesh secured into place with
fibrin sealant decreased the
fibrin sealant. Postoperative complications, incidence of pain, and
recurrence were recorded, as evaluated at 2 weeks, 6 weeks, 1
year, and with a follow-up questionnaire and telephone interview
conducted in May and June 2005.
incidence of chronic pain.
• Laparoscopic inguinal hernia
repair using Surgisis IHM mesh
Results: The operations were successfully performed on all patients
secured with fibrin sealant is an
with no complications or revisions to an open procedure. Average
effective long-term treatment.
follow up was 13 months (range, 1 to 30). One hernia recurred (second
recurrence of unilateral direct hernia), indicating a 2% recurrence rate.
Conclusions: Laparoscopic repair of inguinal hernia using Surgisis
mesh secured with fibrin sealant can be effectively used to treat
primary, recurrent, direct, indirect, and bilateral inguinal hernias in
adults without complications and minimal recurrence within 1 year
follow up.
Keywords: inguinal hernia, laparoscopy, Surgisis mesh, tep repair, fibrin glue.
Point #1: Chronic pain following inguinal hernia repair can be caused by insufficient fixation and material
characteristics.
Insufficient fixation of synthetic surgical mesh during hernia repair can result in folding and wrinkling of the synthetic
material. The abrasive surface characteristics of synthetic materials can result in mechanical pressure on the surrounding
tissue leading to chronic pain. As many as 14.7 % of patients undergoing laparoscopic repair using synthetic surgical mesh
with staple fixation report chronic postoperative pain.1,2
1. Lau H, Patil NG, Yuen WK, Lee F. Prevalance and severity of chronic groin pain after endoscopic totally extraperitoneal inguinal hernioplasty. Surg Endosc. 2003;17:1620-1623.
2. Topart P, Vandenbroucke F, Lozac’h P. Tisseel versus tack staples as mesh fixation in totally extraperitoneal laparoscopic repair of groin hernias: a retrospective analysis. Surg Endosc. 2005;19:724-727.
Point#2: Laparoscopic inguinal hernia repair using Surgisis IHM mesh secured with fibrin sealant decreased the
incidence of chronic pain.
The use of a biodegradable extracellular matrix like SIS with fibrin sealant fixation is advantageous compared to synthetic
mesh and alternative fixation methods. SIS gradually remodels into native host tissue over the span of approximately 6
months and forms a strong repair of organized fibrovascular tissue.3,4 As a result of this remodeling, SIS does not pose a
risk for the abrasive tissue contacting observed with insufficient fixation of synthetic materials. Additionally, the use of fibrin
sealant has been shown to decrease procedure time and reduce the risk of nerve entrapment, osteitis pubis, hematoma, as
well as chronic postoperative pain.2
3. Badylak S, Kokini K, Tullius B, Whitson B. Strength over time of a resorbable bioscaffold for body wall repair in a dog model. J Surg Res. 2001;99:282-287.
4. Badylak S, Kokini K, Tullius B, Simmons-Byrd A, Morff R. Morphologic study of small intestinal submucosa as a body wall repair device.
J Surg Res. 2002;103:190-202.
Point #3: Laparoscopic inguinal hernia repair using Surgisis IHM mesh secured with fibrin sealant is an effective
long-term treatment.
The laparoscopic treatment of inguinal hernia using SIS and fibrin sealant is effective with primary, recurrent, direct,
indirect, and bilateral inguinal hernias. Postoperative complications among the 38 patients were minimal, resolved without
intervention, and occurred at rates that were favorable compared with those reported in the literature.2 The 2% incidence
of recurrence with an average 13–month follow-up indicates the total extra-peritoneal mesh placement technique using
Surgisis IHM with fibrin sealant fixation is an effective treatment for inguinal hernia.
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Bioactive prosthetic material for treatment of hernias.
Edelman DS, Hodde JP.
Surg Technol Int. 2006;15:104-8.
Abstract
Talking Points
Hypothesis: Laparoscopic herniorrhaphy using Surgisis® (Cook
• A total of 82 hernias were
Surgical, Bloomington, IN, USA) mesh is an effective long-term
treatment for repair of inguinal hernia.
Patients and Intervention: Between August 1999 and April 2005,
included in this series, and
78 (95%) were successfully
repaired using either
67 patients underwent laparoscopic inguinal hernia repair by the total
Surgisis ® ES™ or Surgisis ®
extraperitoneal (TEP) mesh placement technique using Surgisis mesh.
IHM™ secured in place
A total of 82 primary direct, indirect, pantaloon, and femoral hernias
using tacks. A laparoscopic
were repaired using this technique.
total extraperitoneal (TEP)
Main Outcome Measures: Postoperative complications and
recurrence as evaluated at two weeks, six weeks, three months, six
months, one year and yearly thereafter for up to five years.
procedure was used.
• Average follow up in this study
was almost three years, with
Results: The operations were successfully performed on all the
some cases going out to six
patients. One revision was done to an open procedure. Postoperative
years without complications.
complications were typical of inguinal hernia surgery. Average followup was 38 months (range: 4-72 months, median: 35 months). Four nontechnical recurrences following repair of direct hernias were reported,
which indicates a 4.9% recurrence rate. No recurrences of indirect
hernias were noted.
• Recurrences were limited to
direct hernias.
• Complications were typical
Conclusions Laparoscopic inguinal herniorrhaphy using Surgisis
of this surgery and included
mesh is effective in treatment primary inguinal hernias in adults with
transient pain, ecchymosis,
minimal complications and recurrence up to 5 years of follow up.
orchitis, and urine retention.
The most common complication
was seroma formation.
Point #1: A total of 82 hernias were included in this series, and 78 (95%) were successfully repaired using either
Surgisis ES or Surgisis IHM secured in place using tacks. A laparoscopic total extraperitoneal (TEP) procedure was
used.
This study shows that Surgisis ES and Surgisis IHM can be successfully used laparoscopically to repair inguinal hernia.
Furthermore, securing the mesh in place with tacks is feasible, as is the use of fibrin glue. Here, the grafts of the final twelve
patients were secured with fibrin glue. Both methods of fixation appear to work equally well with Surgisis. The rate of
success reported in this paper is similar to other reports when synthetics and endoscopic techniques are used.
Point #2: Average follow up in this study was almost three years, with some cases going out to six years without
complications.
This is some of the longest follow-up available on the Surgisis material and demonstrates its longevity. It forms a stable,
long-lasting, and permanent repair without leaving behind synthetic mesh. No long-term complications often associated
with synthetic mesh, such as chronic pain, tissue erosion, or late infection were seen in this series.
Point #3: Recurrences were limited to direct hernias.
The direct hernia is often acquired later in life, appears to be associated with obesity, and occurs medial to the inferior
epigastric vessels in an area of the abdominal wall anatomically thinner than the more lateral aspects. Good tissue contact
with the Surgisis is often hard to achieve in this area, so a larger mesh size and care to ensure good tissue contact may be
important in these cases.
Point #4: Complications were typical of this surgery and included transient pain, ecchymosis, orchitis, and urine
retention. The most common complication was seroma formation.
Complication rates were similar to those reported in the literature for synthetic mesh. Even though seroma occurred in
10/82 (12.2%) of cases and urinary retention occurred in 2/82 (2.4%), this figure is in line with a published meta-analysis of
34 randomized clinical trials showing that seroma can be expected in 12.2% of cases and urinary retention in 3.5%.1 None
of the seromas required intervention, and all resolved spontaneously over time.
1. Schmedt CG, et al. Surg Endosc. 2005;19:188-199.
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Laparoscopic sacral colpopexy: comparison of
nonresorbable prosthetic tape (Mersuture) and a
SIS collagen matrix (Surgisis ES).
Grynberg M, Dedecker F, Staerman F.
Department d ‘Urologie-Andologie, Hospital Robert Debre, Reims, France.
Prog n Uro. 2005;4:751-755.
Abstract
Talking Points
OBJECTIVE: Surgical repair of pelvic prolapse by sacral colpopexy
• SIS performed comparably to a
classically uses nonresorbable prosthetic tape. Infectious or erosive
complications can sometimes occur and are often difficult to treat. The
authors propose the use of a xenogeneic biomaterial composed of an
extracellular collagen matrix: SIS (Small Intestinal Submucosa).
nonresorbable tape (Mersuture)
for sacral colpopexy.
• SIS was well-tolerated in the
MATERIAL AND METHODS: Fifty-seven laparoscopic sacral
pelvic floor based on medium-
colpopexies were performed between November 2001 and December
term follow-up.
2003: 14 using SIS tape (anterior + posterior in 13 cases, anterior only
in 1 case) and 43 using Mersuture PETP nonresorbable tape (anterior +
posterior in 31 cases, anterior only in 10 cases and posterior only in 2
cases). Suburethral support was associated with sacral colpopexy in 40
patients with stress urinary incontinence.
• SIS is completely remodeled
and resorbed within 6
months decreasing long-term
complication risk.
RESULTS: With a mean follow-up of 15.3 months (range: 3-24 months),
one case of recurrent prolapse was observed after 7 months in the
• SIS can be used as a substitute
SIS group. For the PETP group (mean follow-up: 14.6 months, range:
for synthetics in repairing
5-25 months) 3 cases of recurrent prolapse were observed at the
pelvic organ prolapse.
third postoperative month. Two cases of refractory constipation were
observed in the PETP group versus one in the SIS group. The mean
operating time was 100 (1 tape) and 120 minutes (2 tapes) with
difference according to the type of material. The mean hospital stay
was 4.8 days. No infectious complication was observed in either group.
CONCLUSION: These encouraging results suggest that SIS can
constitute an alternative to nonresorbable tape in sacral colpopexy.
It appears to be well tolerated in the medium-term. The functional
characteristics of SIS, replaced within 6 months by newly formed
connective tissue, suggest a lower long-term risk of infection
and erosion.
Point #1: SIS performed comparably to a nonresorbable tape (Mersuture) for sacral colpopexy.
In this small, retrospective analysis, SIS (14 patients) performed comparably to nonresorbable tape (43 patients). This
included one failure (1/14; 7%) for the SIS at 7 months compared to three failures (3/43; 7%) for the nonresorbable tape at
3 months. The only complication of note was refractory constipation which was seen in 1 SIS patient and 2 nonresorbable
tape patients. These results suggest that SIS is a good alternative to nonresorbable tape for sacral colpopexy.
Point #2: SIS was well-tolerated in the pelvic floor based on medium-term follow-up.
This study included follow-up varying from 3 to 24 months. At this level of follow-up, the SIS had performed well. No
complications were noted of patient reaction to the SIS, bolstering the evidence that SIS can be used with success in this
location. Of note, a prospective clinical trial indicated that the medium-term (<1-2 years) was sufficient for measuring clinical
outcomes for sacral colpopexy (30 of 37 failures occurred within 1 year and 36 of 37 failures occurred within 2 years for this
surgery).1 This further supports these authors’ comments that SIS is a viable alternative to synthetics for sacral colpopexy.
1. Am J Obstet Gynecol. 2002. 187:1473-1482.
Point #3: SIS is completely remodeled and resorbed within 6 months decreasing long-term complication risk.
SIS provides long-term support by initiating the host repair mechanisms to replace the SIS with remodeled, functional
tissue. SIS is quickly replaced with host tissue, decreasing the chance of persistent infection as the host defenses are
brought to the repair site. In addition, there is no risk of late-term erosions as the long-term repair is entirely host
tissue. Thus, SIS is an attractive alternative to synthetics for this surgery.
Point #4: SIS can be used as a substitute for synthetics in repairing pelvic organ prolapse.
Repair of pelvic organ prolapse is a common surgical procedure. These authors found that SIS was well-tolerated in this
region. In addition, long-term complications can be avoided with the use of SIS, as it is resorbed and replaced with the
patient’s own tissue. Furthermore, postoperative pain, especially chronic pain, can be minimized with the use of SIS. Inguinal
hernia studies have found less pain associated with the use of SIS compared to synthetic grafts.2,3 These findings, along
with the long-term success of SIS for other soft-tissue reinforcement procedures, such as hernia repair, suggest that SIS has
utility for surgical repair of pelvic organ prolapse.
2. Acta Biomed. 2003. 74 (Suppl 2):10-14.
3. Int Surgery. 2005. 90 (Suppl 3):S21-S23.
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Phone: 353 613 34440
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Surgisis® Biodesign™ Data Guide

Transcription

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