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Randomized, Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Fibrin Sealant VH S/D 4 s-apr
(Artiss) to Improve Tissue Adherence in Subjects Undergoing Rhytidectomy
T. Roderick Hester, Jr., James R. Shire, Davis B. Nguyen, Zachary E. Gerut, Achih H. Chen, Jason Diamond, Julian C. Desmond,
Laura Silvati-Fidell, Steve Zvi Abrams and Rod J. Rohrich
Aesthetic Surgery Journal 2013 33: 487 originally published online 5 April 2013
DOI: 10.1177/1090820X13479969
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Facial Surgery
Randomized, Controlled, Phase 3 Study to
Evaluate the Safety and Efficacy of Fibrin Sealant
VH S/D 4 s-apr (Artiss) to Improve Tissue
Adherence in Subjects Undergoing Rhytidectomy
Aesthetic Surgery Journal
33(4) 487–
­ 496
© 2013 The American Society for
Aesthetic Plastic Surgery, Inc.
Reprints and permission:
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DOI: 10.1177/1090820X13479969
www.aestheticsurgeryjournal.com
T. Roderick Hester Jr., MD, FACS; James R. Shire, MD, FACS; Davis B.
Nguyen, MD; Zachary E. Gerut, MD, FACS; Achih H. Chen, MD, FACS;
Jason Diamond, MD, FACS; Julian C. Desmond, PhD; Laura SilvatiFidell, MS, MA; Steve Zvi Abrams, MD; and Rod J. Rohrich, MD, FACS
Clinical Trial Registration:
This trial was registered with ClinicalTrials.gov (Identification No. NCT00999141) (http://www.clinicaltrials.gov/ct2/show/NCT00999141).
Abstract
Background: Suction drains are commonly placed after rhytidectomy to avoid seroma formation that may result from dead spaces between skin
layers. Fibrin sealants promote tissue adherence by crosslinking with extracellular matrix proteins, which may reduce the dead space under skin flaps.
Objectives: The authors evaluate the safety and efficacy of the fibrin sealant (FS) VH S/D 4 s-apr (Artiss; Baxter Healthcare Corp, Deerfield, Illinois),
added to standard-of-care (SoC) treatment, in improving flap adherence and reducing dead space in patients undergoing rhytidectomy.
Methods: Patients with planned facial rhytidectomy were enrolled in this phase 3, prospective, controlled, randomized, patient-blinded, multicenter
trial. They received SoC treatment on 1 side of the face and adjunctive FS VH S/D 4 s-apr on the other.
Results: Seventy-five patients completed the trial. The mean (SD) drainage volume was 7.7 (7.4) mL from the sides treated with sealant and 20.0
(11.3) mL from the SoC-only sides (P < .0001). Rates of hematoma and seroma were similar for the 2 treatments, as were changes in postoperative skin
sensitivity. Adverse events generally were mild; 2 serious adverse events were reported (wound abscess, dehydration).
Conclusions: Adjunct use of FS VH S/D 4 s-apr in rhytidectomy was proven safe in this study. It significantly reduced drainage volumes without
increasing the incidence of hematoma or seroma, which suggests that it eliminates dead space through improved flap adherence.
Level of Evidence: 2
Keywords
rhytidectomy, fibrin sealant, tissue adherence, facial surgery
Accepted for publication November 8, 2012.
Rhytidectomy has evolved from a procedure in which only
the skin is manipulated to a process of multilayered undermining and repositioning of skin, subcutaneous fat, the
superficial musculoaponeurotic system (SMAS), platysmal
muscle, and the subperiosteal plane. The process of dissecting and undermining the skin in rhytidectomy creates
dead spaces between layers of tissue. Fluid can accumulate in these dead spaces, thereby disrupting adherence
and healing of the overlying flap and possibly causing
postsurgical complications.
Suction drains are traditionally placed after rhytidectomy
to diminish fluid and blood collection, and they may also
reduce the incidence of hematoma and seroma.1 However,
some randomized studies show no beneficial effect of drains
on the incidence of seroma, hematoma, or other postoperative
Corresponding Author:
Dr Julian Desmond, Baxter Healthcare Corporation, One Baxter Way,
Westlake Village, CA 91362-3811 USA.
E-mail: [email protected]
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Aesthetic Surgery Journal 33(4)
complications.2 Moreover, drains have been associated with
complications such as infection, tracts at the site of removal,
injury to vessels during removal, peripheral nerve damage,
local pressure on the flap (which can lead to necrosis), painful extraction, and prolonged nursing care. Improved adherence of the entire undersurface of the flap can reduce or
eliminate the dead space,3 thereby limiting the amount of
space available for fluid accumulation. Therefore, the volume
of fluid collected from drains placed for rhytidectomy may
serve as a surrogate marker of tissue adherence.
Hematoma is a complication resulting from rhytidectomy
that reportedly occurs in 0.2% to 8.0% of women and 7.9%
to 12.9% of men who undergo this surgery.4 Although small
hematomas can be treated by drainage through aspiration
or incision, large expanding hematomas may require reoperation to evacuate the blood and cauterize the bleeding
vessels. Seroma is another complication resulting from rhytidectomy. Various factors contribute to the secretion and
accumulation of fluids and subsequent seroma formation.
These include surgical manipulation of underlying tissues,
surgical creation of dead space during skin-flap elevation
and attachment, and disruption of the lymphatic systems in
the temporal, cheek, and neck regions. The sequelae associated with seroma may include infections, dehiscence, and
skin-flap necrosis, all of which can significantly affect morbidity and recovery rates.
Fibrin sealants are utilized in a variety of surgical procedures for sealing, hemostasis, and adherence purposes. In
plastic and reconstructive surgery, these sealants are used
to attach split-thickness skin grafts to wound beds and to
reduce bleeding and seroma formation.5-12 Thus, products
of this type have the potential to improve healing and
reduce the complications associated with rhytidectomy.
Fibrin sealant with 4 U/mL human thrombin, vaporheated, solvent/detergent-treated synthetic aprotinin (FS VH
S/D 4 s-apr) (Artiss fibrin sealant [human]; Baxter Healthcare
Corp, Deerfield, Illinois) is a dual-component (fibrinogen and
thrombin) product for topical use. This product was initially
investigated for adhering autologous skin flaps during burn
surgery cases. Subsequently, the clinical trial program was
expanded to include assessment of the sealant for potential
benefits in aesthetic procedures. The present phase 3 study
was designed to evaluate and confirm the safety and efficacy
of FS VH S/D 4 s-apr for improving flap adherence in patients
undergoing rhytidectomy.
Methods
Patients
Healthy patients aged 18 to 75 years with plans for full
rhytidectomy were eligible to participate in the trial.
Abbreviated or modified facelift procedures were not permitted, nor were concurrent facial surgery or procedures
to other areas of the body. Additional key exclusion criteria
included previous rhytidectomy surgery, a known bleeding
or coagulation disorder, concurrent treatment with anticoagulants, or use of aspirin within 7 days prior to surgery.
Written informed consent was obtained from all patients
prior to the initiation of any study-related procedures.
Study Design
This phase 3, prospective, controlled, randomized, multicenter clinical trial was conducted between September 2009
and December 2009. Seven study sites in the United States
participated in the trial. The study protocol and informed
consent form were reviewed and approved by the centralized
Western Institutional Review Board (Olympia, Washington)
prior to initiation of the study. In addition, they were
approved by the Institutional Review Board at the University
of Texas Southwestern Medical Center at Dallas for 1 study
site. The trial complied with the principles of the International
Conference on Harmonization Good Clinical Practice and the
Declaration of Helsinki.
One side of each patient’s face was treated with a single
dose of FS VH S/D 4 s-apr intraoperatively as an adjunct to
the standard of care (SoC; routine procedure without application of FS VH S/D 4 s-apr), and the other side received
SoC only. Thus, each patient served as her or his own control. Determination of the side of the face that was to receive
FS VH S/D 4 s-apr with SoC was established by a predefined
randomization process. Patients were aware that both study
product and placebo treatments would be administered, but
they were blinded throughout the entire study as to which
side of their face received each treatment.
Although varying surgical techniques were performed
to achieve complete rhytidectomy (short or standard scar
approaches were permitted, as was plication or elevation
of the SMAS), all surgeries in this study involved full
undermining of the skin and manipulation of the soft tissue. Furthermore, the same surgical procedure was performed on both sides of the face for each patient. The
following procedures were not permitted: minimal-access
cranial suspension, thread lifts, minimal undermining procedures, deep-plane facelifts, and concomitant facial, nasal,
or neck liposuction. Pressure dressings were also not allowed.
Symmetrical fine liposuction of the neck/jowls was permitted at the discretion of the investigator and was documented. Chin and/or cheek implants were also allowed
and documented. Only the principal investigator was permitted to carry out surgical procedures. Most standard
surgical techniques used to achieve hemostasis (eg,
Dr Hester is a plastic surgeon in private practice in Atlanta, Georgia. Dr Shire is a plastic surgeon in private practice in Chattanooga, Tennessee.
Dr Nguyen is a plastic surgeon in private practice in Beverly Hills, California. Dr Gerut is a plastic surgeon in private practice in New York,
New York. Dr Chen is a plastic surgeon in private practice in Evans, Georgia. Dr Diamond is a plastic surgeon in private practice in Beverly
Hills, California. Dr Desmond is a Senior Manager of Clinical Development, Ms Silavati-Fidell is a Senior Biostatistician, and Dr Abrams is a
Medical Director at Baxter Healthcare Corporation in Westlake Village, California. Dr Rohrich is Professor and Chairman of the Department of
Plastic Surgery at the University of Texas Southwestern Medical Center in Dallas, Texas.
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Hester et al489
Figure 1. Drainage collection procedure. (A) Flat 7-mm Blake silicone drains were placed in the lower part of the neck. The
drains were removed 24 hours postoperatively. (B) The contents of each drain were transferred to graduated cylinders for
measurement.
cautery, direct pressure, and gauze pads soaked with epinephrine) were permitted.
Prior to the end of surgery but before the application of
FS VH S/D 4 s-apr, a flat, 7-mm Blake silicone drain
(Ethicon, Inc; Somerville, New Jersey) was placed in the
lower part of the neck on each side of the face (Figure 1A).
The drains were removed 24 ± 4 hours (trial day 1) after
completion of the surgery, or later at the discretion of the
surgeon. Fluids from each drain were transferred to separate, standardized graduated cylinders for accurate measurement of drainage volume (Figure 1B).
Product Administration
FS VH S/D 4 s-apr was applied to the subcutaneous plane
in both the neck and facial area of the side assigned to
receive experimental treatment. The dosing volume of FS
VH S/D 4 s-apr ranged from 0.02 to 0.04 mL/cm2. The
product was applied to the wound bed using a side-to-side
painting motion to achieve a single, thin layer. During
application, gentle pressure was applied at the midline of
the neck to prevent cross-contamination of the control test
site. The flap was held in place for 3 minutes.
Outcome Measures
The primary efficacy end point was the total drainage volume collected from each side of the face at 24 ± 4 hours
postoperatively. The primary safety end point was the incidence of adverse events (AE) related to FS VH S/D 4 s-apr
throughout the study. Safety was evaluated on day 0 (day
of surgery) and on postoperative days 1, 3, 7, and 14.
Secondary end points included the occurrence of hematoma
and seroma on each side of the face, comparison of edema
between the sides of the face, changes in skin sensitivity
from baseline on each side of the face, patient treatment
preference, and patient assessment of numbness (on a
10-point scale, with 10 denoting the greatest numbness).
The investigators inspected the operated areas for hematoma and seroma after surgery on day 0 (encompassing
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Aesthetic Surgery Journal 33(4)
events that occurred on the day of surgery, but after the
surgical procedure) and at all postoperative visits (postoperative days 1, 3, 7, and 14). Any occurrence of hematoma
or seroma on days that were not prescheduled trial visits
was also reported. Multiple hematomas and seromas occurring in the same patient were documented separately. If a
hematoma or a seroma was treated, the type of intervention
and the volume of fluid drained were recorded. Hematomas
or seromas located on the midline of the face and/or neck
were assessed as 2 separate findings (1 on each side of the
face).
The investigators examined patients to determine the
extent of edema on both sides of the face. Skin sensitivity
was assessed using a Semmes-Weinstein Monofilament
set.13 This test was administered at the middle of the
imaginary line running between the tragus and the mouth
commissure, and sensitivity was defined as the smallest
monofilament size felt by the patient. Patient preference
was assessed by asking patients, in an open and holistic
manner, which side of their face they preferred (left, right,
or no preference). Patients were given a number of options
to support their choice: better skin sensation, less numbness, looks better, less bruising, less swelling, less pain, less
itching, less tingling, less feeling of “pins and needles,” and
other (free-text section). Patients were asked in a written
questionnaire to choose all reasons that applied to their
situation. They were also asked to assess their degree of
numbness using a 10-point scale.
Results
Patients
Statistical Analyses
Hematoma/Seroma
We calculated that a sample size of 75 would provide 91%
power to detect a mean (SD) difference in drainage volume between the 2 sides of the face of at least 13.7 (34.5)
mL. The efficacy analysis set comprised all randomized
subjects who underwent facial rhytidectomy, received SoC
or SoC plus FS VH S/D 4 s-apr, and provided data for the
primary efficacy end point. The safety analysis set included
all subjects who underwent facial rhytidectomy and
received SoC or SoC plus FS VH S/D 4 s-apr.
Statistical significance for the primary efficacy end
point (total drainage volume collected from each side of
the face at 24 ± 4 hours postoperatively) was calculated
using a 2-sided paired t test. Utilizing a 2-sided McNemar’s
test of paired proportions, the number of patients with
hematoma/seroma on the SoC-only side of the face exclusively was compared with the number of patients with
hematoma/seroma on the FS VH S/D 4 s-apr side of the
face exclusively. A 95% confidence interval (CI) around
the difference in paired proportions was computed based
on Newcombe’s method.14 The proportion of patients
deemed to have less edema on the side treated with FS VH
S/D 4 s-apr and the proportion deemed to have less edema
on the SoC-only side were computed and presented with a
McNemar 95% CI. Data were analyzed as observed, with
no imputation for missing data.
Of the 79 patients enrolled in the trial, 4 did not complete
it (2 screening failures; 2 withdrawals of consent prior to
surgery). Of the 75 patients who completed the trial, 71
(95%) were women and 4 (5%) were men. The mean
(SD) age was 54.4 (7.4) years (range, 40-71 years), and 74
(99%) of patients were white. The efficacy and safety
analysis sets comprised the 75 patients who completed the
study.
Efficacy
Drainage Volumes
A statistically significant difference in the 24-hour postoperative drainage volumes was observed, favoring the side
of the face treated with FS VH S/D 4 s-apr (P < .0001).
The mean (SD) drainage volume was 7.7 (7.4) mL on that
side of the face as opposed to 20.0 (11.3) mL on the side
treated with SoC only. The mean (SD) difference in the
24-hour postoperative drainage volumes between the 2
sides of the face was 12.3 (11.4) mL, in favor of the side
treated with FS VH S/D 4 s-apr. Although overall drainage
propensity varied among the study sites, volumes were
consistently lower on the sides that received FS VH S/D 4
s-apr treatment (Table 1 and Figure 2).
Five patients experienced a total of 7 hematoma/seroma
events on the side of the face treated with FS VH S/D 4
s-apr (1 hematoma in 1 patient; 6 seromas in 4 patients;
Table 2). On the SoC-treated sides of the face, a total of 8
events occurred in 8 patients (4 hematomas; 4 seromas).
Two of the 75 patients (3%) experienced hematoma/seroma exclusively on the side treated with FS VH S/D 4 s-apr,
and 5 (7%) patients experienced hematoma/seroma exclusively on the side treated with SoC only (Table 2). The
difference was not statistically significant (.040; 95% CI,
–0.039 to 0.125; P = .257). In 3 (4%) of the 75 patients,
hematoma/seroma occurred on both sides of the face.
Most patients (65 of 75; 87%) did not experience hematoma/seroma on either side of the face during the trial.
Four patients required treatment for hematoma/seroma
events on the FS VH S/D 4 s-apr–treated side of the face.
For these individuals, the mean (SD) total volume of aspiration was 5.3 (5.0) mL. Seven patients required treatment
for events on the SoC-only side of the face. For these individuals, the mean (SD) total volume of aspiration was 6.7
(4.7) mL.
Early clinical results are shown in Figures 3 and 4.
Edema
Significantly more patients had less edema on the side
treated with FS VH S/D 4 s-apr at every trial visit (Figure 5).
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Hester et al491
Table 1. Drainage Volume 24 Hours Postoperatively
Site 1 (n = 11)
Site 2 (n = 11)
a
Site 3 (n = 12)
a
FS
Site 4 (n = 11)
SoC
Diff
a
FS
SoC
Diffa
FS
SoC
Diff
9.0
7.0
18.6
11.6
4.9
28.7
23.8
9.9
24.0
14.1
27.0
9.0
8.0
20.0
8.0
4.5
27.5
22.0
10.0
24.0
17.0
11.1
9.1
12.5
5.2
9.5
10.2
4.2
11.5
10.4
4.7
11.4
14.3
Minimum, mL
0
9
–8
0
2
0
0
12
8
0
0
–17
Maximum, mL
39
43
35
16
36
36
11
50
40
17
41
32
Statistic
FS
SoC
Diff
Mean, mL
16.8
25.8
Median, mL
15.0
SD
Site 5 (n = 12)
Site 6 (n = 11)
Site 7 (n = 7)
FS
SoC
Diffa
FS
SoC
Diffa
FS
SoC
Diffa
Mean, mL
3.9
13.3
9.3
1.5
10.6
9.2
11.9
18.1
6.3
Median, mL
3.0
11.5
8.0
0.0
10.0
9.0
12.0
11.0
3.0
SD
4.2
8.4
8.6
2.5
3.4
2.6
3.4
13.1
11.5
Minimum, mL
0
4
–3
0
6
6
6
6
–5
Maximum, mL
12
30
24
8
19
13
15
43
28
Diff, difference; FS, fibrin sealant with 4 U/mL human thrombin, vapor-heated, solvent/detergent-treated synthetic aprotinin + standard-of-care treatment; SD, standard deviation; SoC, standardof-care treatment only.
a
For the diff column, each patient’s difference was computed first and then summarized within the site. Therefore, the mean of the difference will not necessarily equal the difference of the
means—although it is usually close. The difference of the medians will often not equal the median of the diffs.
Adjustments for multiplicity yielded statistically significant
differences for all trial visits except postoperative day 14.
Skin Sensitivity
The data pertaining to skin sensitivity varied greatly
and thus precluded analysis of differences between the
treatments.
Patient Treatment Preference
At each trial visit, the majority of patients stated a preference for the side treated with FS VH S/D 4 s-apr (Figure
6). Common reasons for preferring either treatment were
less swelling, better appearance, and less bruising. In
addition, patients who preferred the FS VH S/D 4 s-apr–
treated side reported experiencing less pain on that side.
Numbness
At each postoperative visit, patients reported more numbness on the SoC-treated side of the face; however, the differences between treatments were small.
Safety
Two serious AE (SAE) were reported. One patient experienced dehydration, and another had a wound abscess with
methicillin-resistant Staphylococcus aureus on the side treated
with FS VH S/D 4 s-apr, which occurred 14 days postoperatively. Although the latter SAE was initially considered
related to treatment, it was later deemed unrelated because
of its late onset in relation to product application. Of the
remaining 35 AE, all were mild in severity except for a case
of corneal abrasion and a case of procedural pain, which
were considered moderate in severity. Two of the non-SAE
were considered related to treatment: 1 patient had mild cellulitis on the side of the face treated with FS VH S/D 4 s-apr
(14 days postoperatively), and 1 patient had mild seroma on
postoperative day 1. A total of 12 facial AE in 11 (15%)
patients occurred exclusively on the sides that received SoC
only. A total of 11 facial AE in 6 (8%) patients occurred exclusively on the side treated with FS VH S/D 4 s-apr. Six facial
AE in 6 (8%) patients occurred on both sides of the face.
Discussion
The present study, which utilized drainage volume as a surrogate marker for dead-space prevalence, suggests that
improved flap adherence can be obtained by applying FS VH
S/D 4 s-apr in patients who undergo rhytidectomy. It is generally accepted that drains may be removed when the total
drainage volume is ≤30 mL (or by inference, ≤15 mL per side
of the face) in a 24-hour period.15 The use of FS in plastic
surgery procedures may eliminate dead space under the skin
flap, leading to a reduction in drainage volume and thereby
avoiding the need for drains.16 Our results suggest that the
use of FS VH S/D 4 s-apr reduced the mean drainage volume
to a level well below the threshold for drain justification (30
mL, or 15 mL per side). In our trial, 91% of patients had a
drainage volume of ≤15 mL from the side of the face treated
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Aesthetic Surgery Journal 33(4)
Table 2. Hematoma/Seroma Incidence
FS Side
SoC Side
Patients with hematoma, n
1
4
Hematomas, n
1
4
Hematomas requiring aspiration, n
1
4
1.0
4.7 (2.4; 2.5-8.0)
Patients with seroma, n
4
4
Seromas, n
6
4
Seromas requiring aspiration, n
3
3
6.7 (5.1; 3.0-12.5)
9.4 (6.3; 4.7-16.5)
Mean volume aspirated, mL (SD; range)
Mean volume aspirated, mL (SD; range)
FS, fibrin sealant with 4 U/mL human thrombin, vapor-heated, solvent/detergent-treated
synthetic aprotinin + standard-of-care treatment; SD, standard deviation; SoC, standard-ofcare treatment only.
Figure 2. Drainage volumes (mL) 24 hours postoperatively
for each patient, according to type of treatment. FS VH S/D 4
s-apr, fibrin sealant with 4 U/mL human thrombin, vaporheated, solvent/detergent-treated synthetic aprotinin; SoC,
standard of care.
with FS VH S/D 4 s-apr in the first 24 hours postoperatively,
whereas only 43% of patients had a drainage volume of ≤15
mL on the SoC-only side. Of the 43 patients whose drainage
volume from the SOC-only side was ≥15 mL 24 hours postoperatively, the corresponding volume for the side treated
with FS VH S/D 4 s-apr was ≤15 mL for 38 of them. These
results imply that adjunct use of FS VH S/D 4 s-apr would
preclude the need for drains in 88% of patients who meet the
criteria for drain placement under SoC.
The rates of hematoma were similar for the 2 treatment
protocols. The rates of seroma were also similar, which
suggests that the reduction in drainage in the 24 hours
immediately following surgery with adjunct FS VH S/D 4
s-apr use was achieved without a coincident increase in
the incidence of seroma or hematoma. Of the seromas that
required aspiration, the mean volume of aspirated fluid
was lower for those that occurred on the side treated with
FS VH S/D 4 s-apr. These findings imply that FS VH S/D 4
s-apr reduces fluid accumulation by eliminating dead
space through improved flap adherence, rather than
merely preventing fluid from reaching the drain. The relatively high incidence of hematoma and seroma observed
in our trial may be attributable to the structure of the
study. The rigorous reporting of safety data that is common in clinical trials such as ours produces more accurate
assessments of AE than do data from observational studies
that use retrospective chart reviews. As expected, very few
patients in our trial were men (4 of 75; 5%), which precluded a subgroup analysis of the rate of hematoma/seroma by sex.
Although the FS VH S/D 4 s-apr–treated sides of the
face had less edema than the SoC-treated sides, the investigators were not blinded to treatment in this trial, which
could have influenced the assessments. Nevertheless, this
finding lends further credence to the hypothesis that
adjunct use of FS VH S/D 4 s-apr reduces fluid accumulation by eliminating dead space through improved
flap adherence, especially because it is consistent with
patient-reported preferences (all patients were blinded to
treatment). At all trial visits, the majority of patients
reported preference for the side of the face treated with FS
VH S/D 4 s-apr. Although patients reportedly had greater
numbness on the side treated with SoC alone, differences
between the numbness levels reported for the SoC sides of
the face as compared with the FS VH S/D 4 s-apr–treated
sides were small. Because of high variance among the
data, we were unable to detect a difference in skin sensitivity between the 2 sides of the face.
The use of FS VH S/D 4 s-apr was associated with a
good safety profile in this trial. These results are consistent
with those observed in previous clinical trials of FS VH
S/D 4 s-apr, including a study conducted in burn patients.17
Conclusions
The findings in this study suggest that adjunct use of FS
VH S/D 4 s-apr in rhytidectomy surgery is safe and, compared with SoC alone, significantly reduces the volume of
drainage (a surrogate marker of improved flap adherence)
in the first 24 hours postoperatively. Moreover, the results
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Hester et al493
Figure 3. (A, C, E) The 41-year-old woman shown in Figure 1 is shown 1 day after undergoing standard-of-are (SoC)
rhytidectomy treatment on the left side of her face, with SoC plus adjuvant treatment with fibrin sealant on the right. (B, D, F)
Seven days postoperatively.
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Aesthetic Surgery Journal 33(4)
Figure 4. (A, C, E) A 49-year-old woman, 1 day after undergoing standard-of-care (SoC) rhytidectomy treatment on the left
side of her face, with SoC plus adjuvant treatment with fibrin sealant on the right. (B, D, F) Seven days postoperatively.
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Hester et al495
Figure 5. Percentage of patients who experienced less
edema on the side of the face treated with fibrin sealant
with 4 U/mL human thrombin, vapor-heated, solvent/
detergent-treated synthetic aprotinin (FS VH S/D 4 s-apr) or
the side treated with standard-of-care (SoC) alone at each
postoperative visit. *P ≤ .001; †P = .027.
suggest that the need for drain placement in rhytidectomy
is reduced when FS VH S/D 4 s-apr is applied. Drainage
reduction was achieved without an increased incidence of
hematoma or seroma, indicating that the application of FS
reduced fluid accumulation by eliminating dead space
through improved flap adherence.
Disclosures
Drs Nguyen, Gerut, Chen, Diamond, and Hester are paid consultants; Dr Shire is a paid consultant, lecturer, and advisory board
member; and Ms Silvati-Fidell and Drs Desmond and Abrams are
employees and stockholders of Baxter Healthcare, the manufacturer of the product discussed in this article. Prof Rohrich is not
a paid consultant for Baxter Healthcare.
Funding
This trial was funded by Baxter Healthcare Corporation, the
manufacturer of the product discussed in this article. All surgeons’ institutions received a research grant from Baxter to
enable them to undertake this study. Baxter assisted with
writing and approved the manuscript, along with the
investigators.
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