VACUlta™ NPWT System - Wounds International

Transcription

VACUlta™ NPWT System - Wounds International
V.A.C.Ulta™
NPWT System
made
PRODUCTS FOR PRACTICE
easy
Volume 3 | Issue 3 | September 2012 www.woundsinternational.com
Introduction
Negative pressure wound therapy (NPWT) offers
clinicians an important option for the advanced
management of many wound types1. Over the past
15 years NPWT has revolutionised care for many
patients with chronic and acute wounds and has
prompted the development of new NPWT systems,
including portable, single-use and wound-specific
devices. This requires a clear understanding of the
characteristics of the various NPWT systems and
applications. The V.A.C.Ulta™ Therapy System (KCI)
is a new device that combines V.A.C.® Therapy (KCI)
with the added option of the controlled delivery of
topical instillation solutions to the wound bed using
V.A.C. VeraFlo™ Therapy (KCI).
Authors: Rycerz A, Vowden K, Warner V, Jørgensen
B. Full author details can be found on page 5.
What is the V.A.C.Ulta™ NPWT System?
The V.A.C.Ulta™ System is an integrated negative pressure wound
therapy (NPWT) system that offers standard NPWT (V.A.C.®
Therapy) and an instillation option using V.A.C. VeraFlo™ Therapy
(Figure 1). This combination system allows instillation solutions to
be delivered to the wound bed to help manage complex, difficultto-heal wounds, before converting to standard NPWT for further
wound therapy. The V.A.C.Ulta™ System eliminates the need for a
separate NPWT unit and manual application of a topical instillation
solution between NPWT cycles.
How does the V.A.C.Ulta™ System deliver
NPWT?
V.A.C.® Therapy is an established method of NPWT and has been
used in the treatment of a variety of wounds since mid 1990s1. The
NPWT delivered by the V.A.C.Ulta™ Therapy System is the same as that
provided by all other KCI V.A.C.® Therapy Systems and offers two therapy
modes, both of which are monitored by SensaT.R.A.C.™ technology:
Q A traditional continuous mode, which delivers negative
pressure to the wound bed in the range of -25mmHg to
-200mmHg
Q Dynamic Pressure Control™ (DPC), which evolved from
intermittent therapy and provides cycles of negative
pressure to the wound bed. This maintains a low level of
negative pressure (-25mmHg) between cycles to minimise
the risk of leaks and fluid accumulation at the wound site.
DPC may also help minimise patient discomfort from foam
expansion that can occur when the negative pressure at the
wound bed returns to 0mmHg.
How does the V.A.C.Ulta™ System deliver
controlled wound instillation?
The V.A.C.Ulta™ System incorporates V.A.C. VeraFlo™ Therapy. This
new technology combines V.A.C.® Therapy with the automated,
controlled delivery and removal of topical wound instillation
solutions at the wound bed (Figure 2).
This includes the following functions:
Q The Fill Assist Tool — this allows the clinician to visually
assess the correct instillation volume. Once set, the same
amount of solution will be delivered for each subsequent
instillation phase
Q The Test Cycle Tool — this runs an abbreviated instillation
cycle to ensure that the system is set up and functioning as
intended
Q The Dressing Soak Tool — this allows the clinician to soak
the dressing with instillation solution, making dressing
removal easier and increasing patient comfort.
V.A.C. VeraFlo™ Therapy uses specially engineered dressings —
the V.A.C. VeraFlo™ Dressing and the V.A.C. VeraFlo Cleanse™
Dressing — which have an open-pore structure that is similar to
V.A.C.® GranuFoam™ Dressings. These dressings help to promote
wound healing and have reduced hydrophobic properties. They
also provide greater mechanical strength for use during instillation
therapy, helping to prevent tearing at dressing changes.
The V.A.C. VeraFlo Cleanse™ Dressing is composed of denser
material than the V.A.C. VeraFlo™ Dressing and is typically chosen
when wound cleansing is the primary goal of therapy. Both
dressings enhance fluid delivery and removal when used in
combination with the V.A.C.Ulta™ System2.
Figure 1 The V.A.C.UltaTM Therapy System
What does the V.A.C.Ulta™
Therapy System offer?
The V.A.C.Ulta™ Therapy System is
a new device that combines V.A.C.®
Therapy and V.A.C. VeraFlo™ Therapy.
V.A.C.® Therapy is an established
method of NPWT, while V.A.C.
VeraFlo™ Therapy allows for the
automated, controlled delivery and
removal of topical wound instillation
solutions at the wound bed. The
V.A.C.Ulta™ Therapy System allows
for the use of NPWT with or without
the addition of instillation fluid.
1
V.A.C.Ulta™
NPWT System
made
PRODUCTS FOR PRACTICE
easy
Figure 2 The mode of action of standard NPWT and NPWT combined with instillation therapy. These systems may help to prepare the wound for primary or secondary closure
Standard NPWT works by1:
Promoting granulation tissue formation
Stimulating cell perfusion
Stimulating local blood perfusion
Removing wound exudate and infectious materials
Reducing local oedema
Providing a closed moist wound environment
NPWT with instillation works by:
Cleansing the wound with instillation of topical
wound cleansers, antimicrobial or antiseptic
solutions
Standard NPWT therapy uses a vacuum to deliver
negative pressure at the wound bed, drawing the
edges of the wound together
Wound irrigation is a long-standing practice
that has been widely accepted for removal of
these barriers to wound healing4. Compared
with swabbing or bathing, wound irrigation
is considered to be the most consistently
effective method of wound cleansing5.
Several publications describe various clinical
applications of instillation therapy, most
of which focus on the treatment of wound
infection. Gabriel et al9 looked at
the use of instillation therapy on soft
tissue infections, demonstrating that
instilling silver nitrate helped reduce
bioburden, decreased time to wound
closure and allowed early hospital discharge.
The instillation of a polyhexanide (PHMB)
solution by Schintler et al10 and Timmers
et al11 showed effective treatment of soft
tissue necrotising fasciitis and osteomyelitis,
respectively, when used in combination
with other treatments. Lehner et al12
reported that the same regimen was an
effective adjunctive therapy for acutely and
chronically infected orthopaedic implants.
The role of instillation fluids
in wound therapy
The role of biofilm
management in wound care
Instillation therapy combined with
NPWT was introduced in 1998 for the
management of septic wounds that had
failed to respond to conventional therapy6.
Initially, this system was used in infected
wounds using antimicrobial solutions. This
combined therapy has now been expanded
to include cleansing regimens that can
help to remove debris, exudate, infectious
agents and healing inhibitors7–8.
It is now widely accepted that many
chronic wounds contain biofilms13.
Biofilms develop when free floating microorganisms attach to the wound surface,
quickly replicating and forming colonies
that are tolerant to antibiotics, antiseptics
and disinfectants13. As a result, systemic
antimicrobial therapy may not be effective.
Good wound bed preparation and topical
antimicrobials are known to play an
When is wound irrigation
indicated?
It is now recognised that wound bed
preparation plays a key role in creating
an optimal wound healing environment.
Regular cleansing of the wound can help to
address the barriers to healing by removing
devitalised tissue, debris, infectious agents
and exudate to help prepare the wound bed
for closure3.
Topical solutions are slowly introduced into the
wound for a defined period using V.A.C. VeraFlo™
Therapy before being removed by negative
pressure
important role in the management
of biofilms13.
Evidence for V.A.C VeraFlo™
Therapy in biofilm
management
Data using a biofilm model with pig
skin explants have shown that V.A.C.
VeraFlo™ Therapy, when combined with
an appropriate antimicrobial solution (eg
0.1% PHMB), may have the ability to disrupt
mature biofilms and to reduce bacterial load
after 24 hours14. This research needs to be
confirmed in human trials, while further work
is needed to determine the most appropriate
solutions, and optimal concentrations, for
use in the management of biofilms. Another
bench study has shown that V.A.C. VeraFlo™
Therapy allows for more controlled wound
cleansing with less aerosolisation compared
with standard techniques, reducing the
potential spread of biofilm-producing
microorganisms during wound cleansing15.
What is the optimal time
for wound irrigation?
There are no national or international
guidelines on the optimal time for irrigating
wounds. However, some investigators have
shown that early intervention is important16–17.
2
A study of open tibial fractures showed a significantly higher infection
rate in patients with wounds treated more than five hours after
trauma compared with those treated within five hours18. All wounds
were treated with debridement without instillation therapy18. More
recently, it has been suggested that appropriate debridement of
extremity wounds should be undertaken as soon as practical followed
by lavage-irrigation using low-pressure delivery systems19.
What pressure is recommended
for wound lavage-irrigation?
There are various wound irrigation techniques used to clean wounds,
including traditional lavage-irrigation systems, which are administered
at low or high pressures. In several studies, it was found that bacterial
burden could be reduced using lavage-irrigation with high-pressure
systems. However, concerns have been raised regarding damage to
Table 1 In-vitro and animal model evidence for V.A.C.Ulta™ and V.A.C VeraFlo™
Reference
Title
Aim
Method
Main findings
Lessing et al. Wounds
2011; 23(10):309-19
Negative pressure wound
therapy with controlled saline
instillation (NPWTi): dressing
properties and granulation
response in vivo
Effect on granulation
tissue formation
In vivo pig model with
full-thickness wounds
(5cm diameter) to
evaluate granulation
tissue thickness over a
7-day period
After 7 days, a significant increase in granulation
tissue thickness (43%; p<0.05) was observed
with V.A.C. VeraFlo™ Therapy compared to V.A.C.®
Therapy alone. Histological findings demonstrated
that the increase in granulation thickness was the
result of new tissue deposition, not swelling
Rycerz et al.
Int Wound J 2012;
doi: 10.1111/j.1742481X.2012.00968.x
Distribution assessment
comparing continuous
and periodic instillation in
conjunction with negative
pressure wound therapy using
an agar-based model
Distribution of
instillation fluid over
the wound bed
Benchtop agar wound
models with and
without tunneling and
undermining
The findings suggest that periodic V.A.C.VeraFlo™
Therapy allowed better solution distribution
across the wound surface, including tunnels and
undermining, when compared with irrigation
LaBarbera et al.
Presented at 22nd
Annual Meeting of
the Wound Healing
Society, 2012
The effects of pulsed lavage
and instillation therapies on
porcine wounds
Effects of wound
cleansing and tissue
damage
In vivo pig fullthickness wounds
(5cm diameter)
allowed to granulate
for 5 days
V.A.C.VeraFlo™ Therapy resulted in significantly
less tissue swelling (ie change in wound volume;
p<0.05) and trauma than did pulsed lavage and
may provide a more gentle technique for wound
cleansing
Clinical evidence for NPWT plus instillation (various applications)
Bernstein and
Tam. Wounds 2005;
17(2):37-48
Combination of sub-atmospheric
pressure dressing and gravity
feed antibiotic instillation in
the treatment of post-surgical
diabetic foot wounds
Effect of NPWT plus
instillation of saline,
polymyxin B and
bacitracin in diabetic
foot wounds
Six hours of NPWT
followed by instillation
therapy in 5 wounds
Decrease in hospital stay and amputation rate
Gabriel et al.
Int Wound J
2008;5(3):399-413
Negative pressure wound
therapy with instillation: a
pilot study describing a new
method for treating infected
wounds
Effect of NPWT plus
instillation (normal
saline, sterile water
or silver nitrate
solution) in patients
with complex,
infected wounds
Pilot study of
15 patients with
complex infected
wounds compared to
retrospective control
of 15 patients treated
with moist gauze
wound care
Patients managed with negative pressure plus
instillation required fewer days treatment and
achieved wound closure sooner with fewer
hospital inpatient days compared with controls
(all p<0.001)
Timmers et al.
Wound Repair Regen
2009;17(2):278-86
Negative pressure
wound treatment with
polyvinyl alcohol foam and
polyhexanide antiseptic
solution instillation in
posttraumatic osteomyelitis
Effect of NPWT plus
instillation, polyvinyl
alcohol foam and
polyhexanide
solution in patients
with osteomyelitis of
the pelvis or lower
extremity
Retrospective case
control cohort study of
30 patients
Patients managed with negative pressure plus
instillation had a 10% recurrence of infection rate
compared to 58.5% for controls. Total duration of
hospital stay was significantly shorter (36 vs 73
days) and the number of surgical procedures was
significantly smaller than controls (2 vs 5; both
p<0.0001)
Schintler
et al. Infection
2009;37(Suppl 1):
31-2
The impact of V.A.C. Instill® in
severe soft tissue infections
and necrotizing fasciitis
Series of 15 patients
treated with NPWT
and instillation
therapy
Infection was controlled and complete healing
achieved in all patients
Lehner et al. Int
Orthop 2011;35(9):
1415-20
First experiences with negative
pressure wound therapy and
instillation in the treatment of
infected orthopaedic implants:
a clinical observational study
Effect of NPWT
plus instillation
(polyhexanide) in
patients with skin
and soft tissue
infections
Effect of NPWTi
(polyhexanide) on
orthopaedic implant
retention following
acute or chronic
infection
Observational study
of 32 patients with an
infected orthopaedic
implant treated with
NPWTi (polyhexanide)
Following treatment, nineteen patients (86%)
with acute infection and eight patients (80%)
with a chronic infection retained their implant at
4-6 months follow-up
3
PRODUCTS FOR PRACTICE
bone and the surrounding tissues caused by
pulsed lavage20–21.
Traditionally, wound lavage-irrigation has
been conducted at pressures less than
15 PSI (lb/1 inch2) using fluid that does not
cause trauma to the surrounding tissue22–23.
V.A.C. VeraFlo™ Therapy uses an instillation
technique in which fluid is slowly introduced
into a cavity under a minimal pressure
of <3 PSI and is allowed to remain for a
pre-specified length of time before being
withdrawn. It therefore falls into the lowpressure category and may provide a less
traumatic wound irrigation method.
Evidence for using NPWT
plus instillation
Pre-clinical trials have shown that the
use of the V.A.C.Ulta™ System with the
V.A.C. VeraFlo™ Therapy setting increases
granulation tissue thickness when
compared to NPWT alone2, reduces
tissue swelling and cleanses the wound
bed by irrigating the wound with saline
and antiseptics (see Table 1). In addition,
clinical studies have shown that NPWT plus
instillation (various methods) can be an
effective therapy in patients with complex,
infected wounds (see Table 1).
What instillation solutions
can be used with the
V.A.C.Ulta™ System?
A range of solutions has been assessed
for compatibility for use with the V.A.C.
VeraFlo™ Therapy components. Solution
classes include:
Q Isotonic solutions such as normal
saline solution and lactated Ringer’s
solution
Q Hypochlorite-based solutions
(eg hypochlorous acid, sodium
hypochlorite) such as Dakin’s solution
(quarter strength only due to risk
of foam degradation); Dermacyn™
[Oculus IS], Microcyn® [Oculus IS]
Q Silver nitrate (0.5%)
Q Sulphur-based solutions (eg
sulphonamides) such as mafenide
acetate (ie sulfamylon)
Q Biguanides (eg polyhexamethylene
biguanide, polyhexanide) such as
Prontosan® and Lavasept® (B. Braun)
Q Cationic solutions (eg octenidine,
benzalkonium chloride) such as
Octenillin® (Schülke), Zephiran®
(sanofi-aventis).
Although these solutions have been
deemed compatible with V.A.C. VeraFlo™
components, further work is required
to provide evidence of clinical efficacy.
Instillation cycle duration and frequency with
V.A.C.VeraFlo™ Therapy vary with respect to
the wound type, patient characteristics and
solution used. It is important that clinicians
Using V.A.C.Ulta™ System with the V.A.C.VeraFlo™ Therapy setting in a patient with a post-incisional hernia repair: a case study
A 68-year-old man presented with an 18-month history of an abdominal wound following surgical
dehiscence post-incisional hernia repair and Hartmann’s procedure. The wound had been treated
with NPWT and healing had progressed, but three deep sinuses and a superficial abdominal wound
remained.
The patient underwent surgery to remove parts of an infected mesh and was initially treated with
a Penrose drain for exudate management. The patient subsequently developed sepsis and wound
contamination with Enterococcus, Coliforms and Pseudomonas.
Treatment
Following consultation with the surgical team a decision was made to initiate the V.A.C.Ulta™ System with
V.A.C. VeraFlo™ Therapy setting to allow for instillation on a regular basis. A hydrocolloid dressing was used
to protect the surrounding skin and superficial abdominal wound. At the start of the treatment all sinuses
were 6cm deep. V.A.C.VeraFlo Cleanse™ Dressings were used due to the ease of application and atraumatic
removal from the sinuses.
Figure 1 Initial application
A 0.1% polyhexamethylene biguanide solution (Prontosan®) was used as the instillation fluid of choice. The
sinuses were irrigated six times within a 24-hour period using 85mL of solution with 15 minutes soak times
with VeraFlo™ Therapy followed by NPWT at -125mmHg. Dressing changes were performed every two days
and wound volume was found to be reducing as measured by the amount of irrigation solution used.
Initially the SensaT.R.A.C.™ Pad was placed over the middle sinus (Figure 1) and this resulted in leakage
around this site. Following review, the pad was bridged away from the sinuses (Figure 2) and no further
leakage occurred.
Figure 2 Revised application
Outcome
The wounds were assessed after one week of therapy using the V.A.C.Ulta™ System with the V.A.C. VeraFlo™
Therapy setting. The sinuses were noted to have decreased in depth by 4cm and were producing less
viscous exudate. Wound swabs showed mixed skin and enteric flora. Due to the improvement in the wound
bed, the patient’s discharge from the hospital was planned and therapy was changed to standard V.A.C.®
Therapy at -125mmHg on continuous therapy.
Figure 3 At discharge
4
refer to the manufacturers’ instructions
for solution-specific considerations prior
to application. In addition, healthcare
professionals should work in close
cooperation with a clinical microbiologist
when choosing a topical antimicrobial or
antibiotic therapy.
When is the V.A.C.Ulta™
System appropriate?
NPWT has a well-established place in the
management of a variety of complex and
hard-to-heal wounds. Three basic criteria
guide the selection of wounds for NPWT:
Q Need for exudate management
Q Need to establish a granulating
wound bed
Q Need to stabilise wound margins.
Whether to select standard NPWT or to add
instillation therapy should be based on the
need for wound cleansing or treatment with
topical antimicrobials or antiseptics.
in the wound to non-healing surgical or
amputation wounds. Patients with chronic
wounds, such as pressure ulcers and diabetic
foot ulcers, could also be considered.
Contraindications and precautions
Contraindications to the use of the
V.A.C.Ulta™ System are the same as
those currently listed for standard NPWT
applications. In addition, V.A.C.VeraFlo™
Therapy should not be used for wound
irrigation in abdominal or thoracic cavities,
while all wounds should be explored prior
to use to avoid the instillation of solutions to
adjacent cavities. Octenisept® (Schülke),
hydrogen peroxide and alcohol-based
solutions are not suitable for use with
V.A.C. VeraFlo™ Therapy components.
The V.A.C.Ulta™ System is not recommended
for use in the outpatient setting. Ideally,
clinicians should wait until a patient’s wound
can be managed with standard NPWT
before discharging them.
Clinical applications
Benefits of using the device
Patients suitable for therapy with the
V.A.C.Ulta™ System may range from
those with infected prosthetic material
The V.A.C.Ulta™ System offers clinicians the
flexibility to switch therapy modes to
customise care for individual patients.
Author details
Rycerz A1, Vowden K2, Warner V3, Jørgensen B4
1. Senior Manager, Research and
Development, KCI, San Antonio, USA
2. Nurse Consultant, Wound Care, Bradford
Teaching Hospitals NHS Trust and the
University of Bradford, Bradford, UK
3. Wound Care Sister, Bradford Royal
Infirmary, Bradford, UK
4. Consultant, Copenhagen Wound Healing
Center, Department of Dermatology,
Bispebjerg University Hospital,
Copenhagen, Denmark
This ‘made easy’ was supported by
an educational grant from KCI. For
further information on the device go to
www.kci1.com or vaculta.com
Disclaimer: Many variables including patient
pathology and clinical techniques may influence
procedural outcomes. Proper clinical procedures and
techniques are necessarily the responsibility of the
medical professional. Each treating physician may
evaluate the appropriateness of the techniques base
on his or her own medical training and expertise.
Before use, medical professionals should review
all risk information, which can be found in the
Instructions for Use in the packaging of each KCI
product. In the case of the V.A.C.VeraFlo™ Therapy
family of products, KCI cannot guarantee any result
nor warrant the efficacy and security of its systems
when used in combination with non-tested and/or
off-label solutions.
Using the V.A.C.Ulta™ System with the V.A.C.VeraFlo™ Therapy setting in a patient with an infected ischeal sinus: a case study
A 55-year-old male paraplegic presented with an infected ischeal sinus resulting from a Category 4
pressure ulcer that had been previously treated for chronic osteomyelitis. He was admitted to
hospital and underwent a washout and surgical debridement of the sinus. Following debridement
the sinus was found to track from the top of the patient’s thigh to the ischeal region to a depth of
12cm (Figure 1).
Treatment
It was decided to start therapy with the V.A.C.Ulta™ System using the V.A.C. VeraFlo™ Therapy setting
(instillation fluid: 0.1% polyhexamethylene biguanide solution [Prontosan®]). The sinus was irrigated with
40mL six times in 24 hours with 15 minutes soak times using the V.A.C. VeraFlo™ Therapy, followed by
NPWT at -125mmHg.
V.A.C. VeraFlo Cleanse™ Dressings were used due to the ease of application and the reduced risk of
leaving foam fibres in the sinus. The sinus opening on the top of the thigh was covered with a hydrofibre
dressing and a hydrocolloid to maintain a seal and encourage wound granulation. Dressing changes
were undertaken every two days. After 11 days of V.A.C. VeraFlo™ Therapy the wound showed significant
improvement and the therapy was changed to Dynamic Pressure Control™ Therapy 3:3 without V.A.C.
VeraFlo™ Therapy, although V.A.C. VeraFlo Cleanse™ Dressings continued to be used due to the ease of
application.
Outcome
After a further 10 days the upper thigh sinus had closed and the depth of the ischeal sinus had decreased
to 3cm. NPWT was discontinued and appropriate dressings applied. The patient was discharged from
hospital to the community with appropriate dressings (Figure 2) and remained healed at the time of
writing.
Figure 1 Wound status at presentation
Figure 2 At discharge
Unless otherwise indicated herein, all trademarks indicated herein are proprietary to KCI Licensing, Inc., its affiliates and/or licensors. The material is
intended for healthcare professionals outside the United States of America only. DSL#12-0536.OUS (9/2012)
5
Using the V.A.C.Ulta™ with the V.A.C.VeraFlo™ Therapy setting in a patient with a diabetic foot ulcer: a case study
A 59-year-old man with type 1 diabetes was admitted with a Wagner grade IV wound resulting
from a prior left forefoot amputation and multiple revisions (Figure 1). The patient had previously
undergone revascularisation of the affected limb. Klebsiella and Enterococcus were present in
the wound.
Treatment
To manage the infection and optimise granulation, V.A.C.Ulta™ Therapy was initiated with the
V.A.C.VeraFlo™ Therapy setting (instillation fluid: 0.1% gentamycin prepared by the local pharmacists, with
advice from the local microbiologist). Solution soak time was set for 20 minutes per session, followed by
V.A.C.® Therapy for 3.5-hours at a pressure of -75mmHg. V.A.C.VeraFlo™ Dressings were used.
Figure 1 Wound at presentation
Outcome
Total length of V.A.C.Ulta™ Therapy with the V.A.C.VeraFlo™ Therapy setting was 17 days, at which stage
the wound was clean and granulation well established. The wound was closed by split-skin grafting 6 days
after cessation of the V.A.C.Ulta™ Therapy (Figure 2) and progressed to healing.
Note: As with any case study, the result and outcomes of the cases presented in this made easy should not
be interpreted as a guarantee or warranty of results. Individual results may vary depending on the patient’s
circumstances and condition.
Figure 2 Following V.A.C.VeraFlo™
Therapy and graft
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Summary
The V.A.C.Ulta™ NPWT System unites two established wound healing modalities in a single device: NPWT
and controlled wound instillation. This combination offers clinicians an important option for the advanced
management of a range of complex wound types. In-vivo and in-vitro data suggest that the V.A.C.Ulta™
System, with the V.A.C.VeraFlo™ Therapy setting, has the potential, when used in conjunction with
appropriate instillation therapy regimens, to help improve healing rates, reduce the length of hospital stays
and provide effective local infection control. Further research in clinical trials is needed to confirm these
findings.
To cite this publication
Rycerz A, Vowden K, Warner V, Jørgensen B. Wounds International 2012; 3(3).
© Wounds International 2012
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