Negative pressure wound therapy

NewsBot · Dec 24, 2008

A blinded, prospective, randomized controlled trial of topical negative pressure wound closure in India.
Mody GN, Nirmal IA, Duraisamy S, Perakath B.
Ostomy Wound Manage. 2008 Dec;54(12):36-46.

Wound closure using topical negative pressure (TNP) has been reported to be effective, but equipment costs can be prohibitive in resource-challenged countries. Because nonhealing wounds are exceedingly common in developing countries such as India, the ability to optimize wound care with limited resources is very important. To investigate the feasibility and efficacy of providing TNP in an Indian medical referral center, a randomized controlled trial comparing a locally constructed TNP device (treatment) to wet-to-dry gauze dressings (control) was conducted. Eligible study participants (N = 48) were recruited from the inpatient wards. Wound etiologies included diabetic foot ulcers (15), pressure ulcers (11), cellulitis/fasciitis (11), and "other" (11). Following enrollment, wound size was assessed using computer-aided measurements of digital photographs and block-randomized to the study arms using a concealed allocation table. Wounds in both treatment groups were débrided before dressing application and patients were followed until wound closure or being lost to follow-up for an average of 26.3 days (+/- 18.5) in the control and 33.1 days (+/- 37.3) in the treatment group. No statistically significant differences in time to closure between the two treatment groups were observed except in a subset analysis of pressure ulcers (mean 10 +/- 7.11 days for treatment and 27 +/- 10.6 days in control group, P = 0.05). Direct costs to close a pressure ulcer also were lower in the TNP than in the control group. A review of the literature suggests the outcomes obtained using a locally constructed TNP device are similar to those obtained using commercially available devices. As a result of this study, a dedicated tissue viability team has been established to identify wounds suitable for TNP, oversee treatment, monitor the need for surgical débridement, and employ wound healing principles and technology appropriately. These results suggest that inexpensive materials can be utilized for TNP wound closure in a developing country.
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NewsBot · Dec 31, 2008

VAC Therapy

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Negative-pressure wound therapy

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NewsBot · Jan 20, 2009

This patent has just been granted:
Subatmospheric pressure wound therapy dressing

A wound dressing apparatus for use in subatmospheric pressure therapy includes an outer member dimensioned for positioning relative to a wound bed and defining an internal reservoir, a port associated with the outer member and in communication with the internal reservoir for applying subatmospheric pressure to the internal reservoir to facilitate treatment of the wound bed and removal of fluid therefrom, an inner member at least partially positionable within the wound bed and confined within the outer member, and an adhesive agent in contact with a peripheral section of the outer member to facilitate attachment of the peripheral section to the periwound tissue. The adhesive agent is preferably substantially devoid of contact with the inner member. In one embodiment, a layer of adhesive material is disposed on the peripheral section of the outer member.
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Link to patent

NewsBot · Feb 3, 2009

NewsBot said: ↑

Smith & Nephew have released their own negative pressure wound therapy system:
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NewsBot said: ↑

Here is KCI's patent on this that was only granted last week (submitted in October 2007)
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Craig Payne said: ↑

Rumour has it that these two companies are (or were) in dispute over this :butcher:
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Press Release:
U.S. Court of Appeals Rules That Smith & Nephew Does Not Infringe KCI Patents

Smith & Nephew's Advanced Wound Management division today announced that the U.S. Court of Appeals for the Federal Circuit upheld a trial court judgment that the gauze-based Versatile 1 negative pressure wound therapy system marketed by Blue Sky does not infringe KCI's patents. Smith & Nephew acquired Blue Sky in May 2007.

"Smith & Nephew welcomes the appeals court decision today that our Versatile 1 negative pressure wound therapy system does not infringe KCI's patents," said Robin Carlstein, Senior Vice President of Advanced Wound Devices at Smith & Nephew. "Today's decision affirmed our long-held belief that our gauze-based systems are a legitimate offering in the broader NPWT market. Smith & Nephew will continue operating in this important space. Most importantly, we remain dedicated to using innovative technologies to improve patients' live."
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NewsBot · Feb 5, 2009

Vacuum assisted wound closure in patients with lower extremity arterial disease. The experience from two tertiary referral-centres.
Nordmyr J, Svensson S, Björck M, Acosta S.
Int Angiol. 2009 Feb;28(1):26-31.

AIM: The purpose of this investigation was to analyze predictors for wound healing, amputation and mortality after vacuum assisted closure (VAC(R)) therapy of wounds in the lower limb in patients with arterial disease.

METHODS: One hundred and twenty one wounds were treated and followed for 12 months at two vascular centres in Uppsala and Malmö, Sweden. VAC(R) therapy was applied in the wound at a topical negative pressure of 125 mmHg.

RESULTS: Median age of the patients was 74 years and critical lower limb ischemia was present in 87% of the patients at admission. Intestinal flora was cultivated in 74% of the wounds. VAC(R) associated bleeding occurred in four patients. Complete wound healing was achieved in 66%. Deep groin infections were associated with synthetic graft infection (P<0.001), treatment outside hospital (P<0.001), faster healing (P<0.01) and lower amputation rate (P<0.005). Diabetes mellitus (OR 2.7; [95% CI 1.2-6.2]) and foot wound (OR 3.0; [95% CI 1.2-7.4]) were independent predictors for amputation. The absence of complete wound healing was the strongest factor for both amputation (P<0.001) and death (P<0.001).

CONCLUSIONS: VAC(R) therapy of complex wounds in the lower limbs in patients with vascular disease was associated with high healing rates. Non-healed wounds after VAC(R) therapy were predictors for amputation and death.
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NewsBot · Mar 4, 2009

Negative-pressure wound therapy II: negative-pressure wound therapy and increased perfusion. Just an illusion?
Kairinos N, Voogd AM, Botha PH, Kotze T, Kahn D, Hudson DA, Solomons M.
Plast Reconstr Surg. 2009 Feb;123(2):601-12.

BACKGROUND: A recent study demonstrated that negative-pressure wound therapy increases underlying tissue pressure. This finding is incongruous with studies using laser Doppler that show that perfusion is immediately increased on initiation of suction. This study investigated perfusion in negative-pressure wound therapy using two alternative modalities.

METHODS: Radioisotope perfusion imaging was used to determine perfusion beneath circumferential negative-pressure wound therapy dressings on 20 healthy hands (n = 20). Ten hands received suction pressures of -400 mmHg and 10 received -125 mmHg, with the contralateral hand used as a control without any suction. Transcutaneous partial pressure of oxygen was used to determine perfusion beneath noncircumferential negative-pressure wound therapy dressings on 12 healthy legs (n = 12), with each volunteer being sequentially randomized to receive suction pressures of -400 and -125 mmHg, respectively.

RESULTS: Tissues undergoing circumferential negative-pressure wound therapy demonstrated a mean reduction in perfusion of 40 +/- 11.5 percent (p < 0.0005) and 17 +/- 8.9 percent (p < 0.0005) at suction pressures of -400 mmHg and -125 mmHg, respectively. Perfusion reduction at -400 mmHg was significantly greater than at -125 mmHg (p < 0.015). In the noncircumferential negative-pressure wound therapy group, there was a mean reduction in transcutaneous partial pressure of oxygen of 7.35 +/- 7.4 mmHg (p < 0.0005) and 5.10 +/- 7.4 mmHg (p < 0.0005) at suction pressures of -400 mmHg and -125 mmHg, respectively. There was a tendency for greater reductions in the -400 mmHg group, but this was not significantly different from the -125 mmHg group (p = 0.07).

CONCLUSIONS: These findings demonstrate that perfusion beneath negative-pressure wound therapy decreases for increasing suction pressure. Thus, it is suggested that negative-pressure wound therapy should be used with caution on tissues with compromised vascularity, particularly when used circumferentially.
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NewsBot · Mar 4, 2009

Negative-pressure wound therapy I: the paradox of negative-pressure wound therapy.
Kairinos N, Solomons M, Hudson DA.
Plast Reconstr Surg. 2009 Feb;123(2):589-98;

BACKGROUND: Does negative-pressure wound therapy reduce or increase the pressure of wound tissues? This seemingly obvious question has never been addressed by a study on living tissues. The aim of this study was to evaluate the nature of tissue pressure changes in relation to negative-pressure wound therapy.

METHODS: Three negative-pressure wound therapy dressing configurations were evaluated-circumferential, noncircumferential, and those within a cavity-on 15 human wounds, with five wounds in each category. Tissue pressure changes were recorded (using a strain gauge sensor) for each 75-mmHg increment in suction, up to -450 mmHg. In the circumferential and noncircumferential groups, tissue pressure was also measured over a 48-hour period at a set suction pressure of -125 mmHg (n = 10).

RESULTS: In all three groups, mean tissue pressure increased proportionately to the amount of suction applied (p < 0.0005). Mean tissue pressure increments resulting from the circumferential dressings were significantly higher than those resulting from the noncircumferential (p < 0.0005) or cavity group (p < 0.0005); however, there was no significant difference between the latter two groups (p = 0.269). Over the 48-hour period, there was a significant mean reduction in the (increased) tissue pressure (p < 0.04 for circumferential and p < 0.0005 for noncircumferential), but in only three of 10 cases did this reduce to pressures less than those before dressing application.

CONCLUSIONS: Negative-pressure wound therapy increases tissue pressure proportionately to the amount of suction, although this becomes less pronounced over 48 hours. This suggests that negative-pressure wound therapy dressings should be used with caution on tissues with compromised perfusion, particularly when they are circumferential.
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NewsBot · Mar 26, 2009

NewsBot said: ↑

Press Release:
U.S. Court of Appeals Rules That Smith & Nephew Does Not Infringe KCI Patents
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Its a different story in Germany. Just picked up this from a German press release:
KCI nimmt Antrag auf einstweilige Verfügung gegen Smith & Nephew in Deutschland zurück

Here is Google Translate version of the German press release, which does not coe up too well, but you get the message:

KCI Notes application for interim injunction against Smith & Nephew in Germany
The Advanced Wound Management Division (LSE: SN, NYSE: SNN) vonSmith & Nephew announced that they have been informed dassKinetics Concepts, Inc. (KCI) (NYSE: KCI) on Monday, 23 März2009, ihren beim Landgericht Düsseldorf gestellten Antrag aufeinstweilige Verfügung gegen Smith & Nephew wegen Verletzung desKCI-Patents zur Unterdruckwundtherapie (NPWT) zurückgenommen hat.Dies erfolgte im Anschluss an eine erstinstanzliche, berufungsfähigeEntscheidung des Bundespatentgerichts vom 17. März2009, the Landgericht Dusseldorf her request aufeinstweilige injunction against Smith & Nephew for patent infringement desKCI to Unterdruckwundtherapie (NPWT) hat.Dies was withdrawn following a first, berufungsfähigeEntscheidung the Federal Patent Court, 17 März 2009 in einemNichtigkeitsverfahren, in der das Gericht das Patent für nichtigerklärte und zurückwies. EinemNichtigkeitsverfahren in March 2009, the court in the patent for nichtigerklärte and dismissed.

Diese Entscheidung ermöglicht es Smith & Nephew, ihr gesamtesNPWT-Produktportfolio, einschliesslich des RENASYS-F Schaums und derRENASYS-G Gazeverbände, weiterhin in Deutschland zu vertreiben. This decision will enable Smith & Nephew, gesamtesNPWT its product portfolio, including the F-RENASYS foam and derRENASYS-G Gazeverbände continue to distribute in Germany.

"Wir sind äusserst zufrieden mit KCIs Entscheidung, ihren Antragauf einstweilige Verfügung zurückzuziehen", sagte Markus Sebastian,Geschäftsführer Wound Management, Smith & Nephew GmbH. "Wir werdenuns weiter bemühen, ein Portfolio an NPWT-Produkten in Deutschlandanzubieten, das den medizinischen Anwendern die Möglichkeit gibt,frei zu entscheiden, welche Unterdruckwundtherapie-Behandlung für denEinzelfall optimal ist. Deutschland war und ist ein wichtiger Marktfür Smith & Nephew, was die Entscheidung des Bundespatentgerichts undKCIs Antragsrücknahme für die Firma so bedeutsam macht." "We are extremely pleased with KCIs deciding their Antragauf injunction retreat," said Mark Sebastian, Managing Director Wound Management, Smith & Nephew, Inc. "We continue to strive werdenuns, a portfolio of NPWT products in Deutschlandanzubieten that the medical users the opportunity are free to decide which Unterdruckwundtherapie treatment is optimal for denEinzelfall. Germany was and is an important Marktfür Smith & Nephew, which is the decision of the Federal Patent Court undKCIs request for redemption, the company is so important. "
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NewsBot · May 2, 2009

Press Release:
Smith & Nephew Encouraged by United Kingdom NPWT Patent Court Decision

Hull, United Kingdom -1 May, 2009 - Smith & Nephew's Advanced Wound
Management business (LSE: SN; NYSE: SNN) announces that the Patents
Court, in the High Court of Justice of England and Wales, has ruled
as invalid 7 out of the 10 claims asserted against Smith & Nephew of
the Negative Pressure Wound Therapy (NPWT) patent EP 0620720, that is
licensed to Kinetic Concepts, Inc (KCI) (NYSE: KCI). The 3 other claims
asserted in the patent remain in effect in the United Kingdom. The
decision is subject to appeal and Smith & Nephew will be pursuing its
appeal to invalidate those three claims as a matter of urgency.

Smith & Nephew is pleased that this judgement has invalidated the main
claim of the EP 0620720 patent. This complements the German
decision of March 2009 where at the Federal Munich Patent Court
the court ruled (subject to appeal) that all claims
of the patent are invalid."We will continue to serve the United Kingdom
NPWT market and offer the
new RENASYS* EZ, RENASYS* GO and RENASYS*-G (gauze) NPWT products.
Smith & Nephew remains committed to our strategy to ensure that
clinicians have a range of treatment options. This ruling has no
impact on Smith & Nephew's ability to sell gauze-based NPWT systems,
and we will continue our efforts to ensure that clinicians have options
in NPWT. We intend to pursue the remaining asserted claims as a matter
of urgency," said Robin Carlstein, Senior Vice President of Advanced
Wound Devices at Smith & Nephew.
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NewsBot · May 12, 2009

Negative pressure wound therapy for soft tissue injuries around the foot and ankle.
Lee HJ, Kim JW, Oh CW, Min WK, Shon OJ, Oh JK, Park BC, Ihn JC.
J Orthop Surg Res. 2009 May 9;4(1):14. [Epub ahead of print]

BACKGROUND: This study was performed to evaluate the results of negative pressure wound therapy (NPWT) in patients with open wounds in the foot and ankle region. Materials and Methods: Using a NPWT device, 16 patients were prospectively treated for soft tissue injuries around the foot and ankle. Mean patient age was 32.8 years (range, 3-67 years). All patients had suffered an acute trauma, due to a traffic accident, a fall, or a crush injury, and all had wounds with underlying tendon or bone exposure. Necrotic tissues were debrided before applying NPWT. Dressings were changed every 3 or 4 days and treatment was continued for 18.4 days on average (range, 11-29 days).

RESULTS: Exposed tendons and bone were successfully covered with healthy granulation tissue in all cases except one. The sizes of soft tissue defects reduced from 56.4cm2 to 42.9cm2 after NPWT (mean decrease of 24%). In 15 of the 16 cases, coverage with granulation tissue was achieved and followed by a skin graft. A free flap was needed to cover exposed bone and tendon in one case. No major complication occurred that was directly attributable to treatment. In terms of minor complications, two patients suffered scar contracture of grafted skin.

CONCLUSION: NPWT was found to facilitate the rapid formation of healthy granulation tissue on open wounds in the foot and ankle region, and thus, to shorten healing time and minimize secondary soft tissue defect coverage procedures.
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NewsBot · Jul 22, 2009

Negative-pressure wound therapy versus standard wound dressing in the treatment of diabetic foot amputation. A randomised controlled trial.
Sepúlveda G, Espíndola M, Maureira M, Sepúlveda E, Fernández JI, Oliva C, Sanhueza A, Vial M, Manterola C.
Cir Esp. 2009 Jul 17.

INTRODUCTION: Foot amputation wounds in patients with diabetes are complex and treatment is often difficult. At the moment negative pressure wound therapy (NPWT) is widely used for the treatment of several types of wounds. Nevertheless, the clinical evidence to support the application of this dressing in foot amputation wounds in patients with diabetes is scarce. The aim of this study was to evaluate the efficacy of NPWT compared with standard wound dressing to treat diabetic foot amputation wounds.

PATIENTS AND METHOD: Randomised controlled trial. Diabetic patients aged 18 years or older with a foot amputation wound were assigned to treatment with NPWT (A group) or standard wound dressing (B group). Primary efficacy end point was time in reaching 90% of wound granulation. A size of sample of 11 patients per group was used. NPWT was prepared with a polyurethane ether foam dressing, a Nelaton catheter, a transparent adhesive drape and continuous negative pressure of 100mmHg. The wound was treated every 48-72h and evaluated weekly. Descriptive and analytical statistics were used.

RESULTS: There were 24 patients, with a mean age of 61.8+/-9 years (79% men), 12 in each group. The average time to reach 90% of granulation was lower in A group (18.8+/-6 days versus 32.3+/-13.7 days), a statistically significant difference (P=0.007).

CONCLUSION: NPWT reduces the granulation time of diabetic foot amputation wounds by 40%, compared with the standard wound dressing.
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NewsBot · Jul 26, 2009

NewsBot said: ↑

Press Release:
U.S. Court of Appeals Rules That Smith & Nephew Does Not Infringe KCI Patents
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This story continues:

Press Release:
UK Court of Appeal Rules in Smith & Nephew's Favour

Smith & Nephew's Advanced Wound Management division (LSE: SN) (NYSE: SNN) announced that the UK Court of Appeal has ruled as invalid all claims asserted against Smith and Nephew of the patent EP 0 626 720 that is licensed to Kinetic Concepts, Inc. (NYSE: KCI). As a result, the preliminary injunction against Smith & Nephew's RENASYS(TM)-F NPWT system has been lifted.

The Patents Court had ruled on 1 May, 2009 that 7 out of 10 claims asserted were invalid but that the remaining 3 had been infringed by Smith & Nephews RENASYS-F dressing. This decision was appealed and subsequently won by Smith & Nephew with today's Court ruling.

"This favourable ruling for Smith & Nephew clears a major legal hurdle in the UK allowing us to offer our customers the breadth of NPWT products with proven clinical efficacy," said Robin Carlstein, Senior Vice President of Advanced Wound Devices at Smith & Nephew. "Clearly, we are pleased with the UK Court of Appeal's findings in this matter and look forward to servicing our customers with our RENASYS(TM)-F NPWT products in a very important market for the company."
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Press Release:
KCI Announces Intention to Appeal UK Court Ruling Revoking NPWT Patent

Kinetic Concepts, Inc. (NYSE: KCI) announced today that the Court of Appeal of England and Wales has revoked a patent licensed to KCI from Wake Forest University. The Court determined that the KCI patent (EP UK 0 620 720) covering the use of foam dressing kits with Negative Pressure Wound Therapy (NPWT) systems is not valid and lifted a previously issued injunction against Smith & Nephew (LSE: NS; NYSE: SNN). The lower court had ruled that key claims in the patent were valid and enforceable, which established the basis for the injunction.

"We are disappointed with this ruling and plan to appeal the decision to the House of Lords," said Stephen Seidel, KCI Executive Vice President, Chief Administrative Officer and General Counsel. "This ruling is limited to the UK patent at issue and does not directly affect the other patents in KCI's portfolio or any other proceedings outside the UK."
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Press Release:
United States Patent Office Issues Decision in Re-examination Proceedings

Smith & Nephew Inc.'s Advanced Wound Management division announced that the United States Patent and Trademark Office (Patent Office) has issued actions in re-examination proceedings involving three of the negative pressure wound therapy (NPWT) patents licensed to Kinetic Concepts, Inc. , confirming the patentability of the re-examined claims. The re-examination proceedings are still pending, and Smith & Nephew intends to pursue its appeal rights.

These actions from the Patent Office do not affect Smith & Nephew's ability to defend the pending U.S. district court lawsuit, and do not affect Smith & Nephew's ability to continue to sell any of its NPWT products in the U.S., including foam products.

"Smith and Nephew entered the NPWT marketplace to meet the clear demand for options that enable clinicians to use NPWT with their own best clinical judgment," said Tom Dugan, President, North America, Advanced Wound Management. "We have been confident in our IP position from the onset, and convinced that competition in this marketplace would bring value to customers and ultimately help physicians and their patients. Our position has been validated by courts in Germany and the United Kingdom, which revoked KCI's European counterpart patent in lawsuits KCI brought against Smith & Nephew in those countries, and we remain confident of our position as we approach pending litigation in the U.S. and Australia."
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NewsBot · Aug 4, 2009

Topical negative pressure wound therapy (TNPWT): current practice in New Zealand.
Laney J, Roake J, Lewis DR.
N Z Med J. 2009 May 22;122(1295):18-26.

AIM: To survey current opinion, regarding TNPWT, from New Zealand vascular surgeons.

METHOD: Registered vascular surgeons currently practicing in New Zealand were identified from the Vascular Society of New Zealand (VSNZ) database. A questionnaire was emailed asking if they used TNP in their vascular surgical practice and whether or not they considered themselves 'up to date' regarding published evidence for TNP. Surgeons were also asked how often and how successful they felt that TNP was in different clinical situations (arterial ulcers [after revascularisation]; venous ulcers; mixed arterial/venous ulcers; following debridement of the 'diabetic (Db) foot'; lower limb (LL) surgical wound infections/dehiscences; and lymphocoeles/seromas/lymph fistulas not treated successfully with conservative management). One email reminder, followed by a hard copy reminder was sent to those who failed to respond to the first email.

RESULTS: Of 38 vascular surgeons 34 responded (89.5%). Median response time was 3.38 days (range 12 min-11.8 days). 28 (82%) vascular surgeons used TNP in their NZ clinical practice. 17 (50%) considered themselves up to date regarding published evidence, 8 (23.5%) admitted to not being up to date with the evidence and 9 (26%) did not know. TNP appears to be used most frequently and with most success following debridement of diabetic foot wounds and in the management of infected/dehisced surgical wounds.

CONCLUSION: TNPWT is widely used by NZ vascular surgeons, despite many not considering themselves up to date regarding published evidence. It is most favoured for treating diabetic feet post debridement and for lower limb surgical wounds
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NewsBot · Aug 18, 2009

Vacuum assisted closure (VAC) in the treatment of advanced diabetic foot.
Dzieciuchowicz L, Espinosa G, Grochowicz L.
Cir Esp. 2009 Aug 13. [Epub ahead of print]

INTRODUCTION: Deep diabetic foot lesions pose an enormous therapeutic problem. The purpose of this study was to present the experience of the use of vacuum assisted closure (VAC) in the treatment of advanced and complicated diabetic foot lesions.

MATERIAL AND METHODS: Five cases of advanced diabetic foot that were treated with VAC were prospectively studied. Three patients were diagnosed with renal failure, including one with renal transplant, who were receiving immunosuppression therapy. Four patients had undergone local foot surgery. The foot lesions were classified as grade 3 or 4 according to the Wagner classification. In all patients extensive debridement was performed that resulted in open minor amputations in four cases and resection of the metatarsophalangeal joint in one case. The VAC was applied during the same procedure. The median follow-up period of the patients was 9 months.

RESULTS: Foot salvage was achieved in all cases. The median number of changes of VAC was 16 within median period of 8 weeks. Half of the changes were performed as an outpatient procedure. There were no major complications or clinical signs of infection observed. In one case before treatment with VAC began, angioplasty of the iliac artery and superficial femoral artery was performed. Other interventions carried out after the treatment was started were, two distal revascularizations and two partial transmetatarsal amputations.

CONCLUSIONS: VAC appears to be very useful in the treatment of advanced diabetic foot lesions.
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NewsBot · Oct 6, 2009

A new patent has just been granted for this:
VACUUM WOUND THERAPY WOUND DRESSING WITH VARIABLE PERFORMANCE ZONES

A dressing for an open wound includes a cover layer dimensioned for positioning relative to a wound bed. The cover layer permits an evacuation of the space around the wound bed such that a sub-atmospheric pressure may be established to stimulate healing and facilitate the removal of fluid from the wound. Multiple performance zones in the cover layer allow the wound dressing to remain in position through repeated cycles of evacuation without placing undue strain on the wound bed. An outer peripheral zone may include a high peal-strength adhesive while an intermediate zone may include a shear resistant adhesive. A central zone may be devoid of any coating to maximize moisture transmission through cover layer.
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admin · Nov 13, 2009

This clinical trial was just registered:
A Clinical Investigation to Evaluate Negative Pressure Wound Therapy (NPWT) System in the Treatment of Diabetic Foot Ulcers (DFUs) Including Post Amputation Wounds Associated With Diabetes

Purpose
Primary objective

•To assess wound healing and granulation tissue formation when using the Avance™ NPWT system
Secondary objectives

•To investigate the pain level at dressing removal
•To visually check exudate removal
•To investigate the ease of use for the subject and care giver when using the Avance™ NPWT system
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NewsBot · Dec 2, 2009

This clinical trial has just been registered:

Efficacy Study of a Bioelectric Dressing Used With Negative Pressure Wound Therapy to Treat Diabetic and Pressure Ulcers

The purpose of this study is to determine whether a bioelectric wound dressing, used in conjunction with Negative Pressure Wound Therapy (NPWT), is effective in the treatment of diabetic and pressure ulcers of the foot.
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NewsBot · Mar 12, 2010

NewsBot said: ↑

Press Release:
U.S. Court of Appeals Rules That Smith & Nephew Does Not Infringe KCI Patents
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Jury rules against Smith & Nephew in Kinetic Concepts patent case

A federal jury in Texas found that a negative pressure wound therapy product marketed and sold by Smith & Nephew infringed on two patents owned by Wake Forest University and licensed to Kinetic Concepts Inc.

The jury held that each of the patents in the case are valid and KCI and Wake Forest are entitled to damages, a release from KCI said. The company said it would seek an injunction in post-trial proceedings in the U.S. District Court in San Antonio against Smith & Nephew.

The ruling is the latest development in an ongoing battle between San Antonio, Texas-based Kinetic Concepts (NYSE: KCI) and Smith & Nephew plc (NYSE: SNN), headquartered in London and with the North American headquarters for its Advanced Wound Management division in St. Petersburg. The companies have been embroiled in a series of patent disputes worldwide.
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Full story

NewsBot · Apr 21, 2010

This clinical trial has just been registered:
Comparing the Efficacy of the ConvaTec Engenex® Negative Pressure Wound Therapy Device to Moist Wound Therapy in the Treatment of Diabetic Foot Wounds

This is an investigator-initiated prospective, randomized, controlled study. Hypothesis/Objective: The study will evaluate the rates of wound healing among patients with lower extremity diabetic wounds comparing two groups of patients. Group 1, the control group, will be treated with the standard of care treatment of moist wound therapy. Group 2 will be treated with ConvaTec Engenex® NPWT. Both groups will be treated in the inpatient and outpatient setting. It is expected that the NPWT device will be an effective therapy that expedites time to closure and demonstrates a significant decrease in the size and depth of the wound over the course of the 12 week therapy as compared to the standard of care.
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drwmmiller · Apr 30, 2010

We had a case of a traumatic amputation of a forefoot secondary to a lawnmower accident. As opposed to a skin graft, we used VAC therapy. Although timely, the entire wound granulated and healed in three months. The trauma was akin to a trans-met amputation. It was intilially surgically debrided at first. We are currently attempting to publish this case.

NewsBot · Jun 11, 2010

Effectiveness of Vacuum-assisted Closure (VAC) Therapy in the Healing of Chronic Diabetic Foot Ulcers.
Nather A, Chionh SB, Han AY, Chan PP, Nambiar A.
Ann Acad Med Singapore. 2010 May;39(5):353-6.

Introduction: This is the fi rst prospective study done locally to determine the effectiveness of vacuum-assisted closure (VAC) therapy in the healing of chronic diabetic foot ulcers.

Materials and Methods: An electronic vacuum pump was used to apply controlled negative pressure evenly across the wound surface. Changes in wound dimension, presence of wound granulation and infection status of diabetic foot ulcers in 11 consecutive patients with diabetes were followed over the course of VAC therapy.

Results: Healing was achieved in all wounds. Nine wounds were closed by split-skin grafting and 2 by secondary closure. The average length of treatment with VAC therapy was 23.3 days. Ten wounds showed reduction in wound size. All wounds were satisfactorily granulated and cleared of bacterial infection at the end of VAC therapy.

Conclusions: VAC therapy was useful in the treatment of diabetic foot infection and ulcers, which after debridement, may present with exposed tendon, fascia and/or bone. These included ray amputation wounds, wounds post-debridement for necrotising fasciitis, wounds post-drainage for abscess, a heel ulcer and a sole ulcer. It was able to prepare ulcers well for closure via split-skin grafting or secondary closure in good time. This reduced cost of VAC therapy, as therapy was not prolonged to attain greater reduction in wound area. VAC therapy also provides a sterile, more controlled resting environment to large, exudating wound surfaces. Large diabetic foot ulcers were thus made more manageable.
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NewsBot · Jul 3, 2010

Analysis of Nerve and Neuropeptide Patterns in Vacuum-Assisted Closure-Treated Diabetic Murine Wounds.
Younan G, Ogawa R, Ramirez M, Helm D, Dastouri P, Orgill DP.
Plast Reconstr Surg. 2010 Jul;126(1):87-96.

BACKGROUND:: Reestablishment of the peripheral nervous system occurs in parallel with wound healing. With accelerated wound healing seen with the vacuum-assisted closure device, the authors studied its effects on nerve fiber regeneration, nerve sprouting, and the stimulation of neuropeptides and neurotrophins.

METHODS:: A vacuum-assisted closure device was applied to a full-thickness diabetic mouse wound using continuous or cyclical modes and compared with foam dressing or occlusive dressing controls, using 10 mice per group. Nerve fibers, substance P, calcitonin gene-related peptide, and nerve growth factor were analyzed using two-dimensional immunohistochemistry and real-time reverse-transcriptase polymerase chain reaction.

RESULTS:: A significant increase in dermal and epidermal nerve fiber densities and in substance P, calcitonin gene-related peptide, and nerve growth factor expression was seen in vacuum-assisted closure-treated wounds. Cyclical treatment mode correlated with the largest increase in granulation tissue production, wound surface microdeformations, and a slightly faster wound closure rate.

CONCLUSIONS:: This study suggests that vacuum-assisted closure therapy can modulate nerve fiber and neuropeptide production in the wound. Optimized kinetics of vacuum-assisted closure application may provide an opportunity for clinicians to further improve wound healing in denervated wounds such as pressure sores and diabetic foot ulcerations.
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NewsBot · Sep 25, 2010

Press Release:
New Laboratory Data Analyzes Physical Performance Characteristics Of Unique Bio-Dome™ And GranuFoam™ Negative Pressure Wound Therapy

ConvaTec, a world-leading developer and marketer of innovative medical technologies for community and hospital care, announced new in vitro study results. The Engenex® Negative Pressure Wound Therapy (NPWT) system's Bio-Dome™ wound interface showed superior tensile strength and lower simulated bioadhesion when compared with GranuFoam™ (polyurethane foam).(1) This study was conducted by employees of ConvaTec's Global Development Center and was presented at The Annual Fall Symposium on Advanced Wound Care in Anaheim, California.

In addition to the superior tensile strength and lower simulated bioadhesion, the laboratory tests also showed that the Bio-Dome™ wound interface provided broader contours of microstrain when compared to GranuFoam™. The Bio-Dome™ wound interface also effectively transmitted sufficient levels of fluid to the canister from simulated highly exuding wounds.(1)

To better understand the physical performance attributes of wound interfaces, a range of in vitro physical testing and analytic studies using different levels of applied negative pressure were performed.

The analytic studies included finite element analysis (FEA) to predict strain forces applied to the wound bed; fluid handling testing to simulate exudate management capabilities; tensile strength of interface dressings to show their robustness during handling; and simulated bioadhesion testing.
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NewsBot · Oct 1, 2010

Economic evaluation of Vacuum Assisted Closure(®) Therapy for the treatment of diabetic foot ulcers in France.
Whitehead SJ, Forest-Bendien VL, Richard JL, Halimi S, Ha Van G, Trueman P.
Int Wound J. 2010 Sep 28. doi: 10.1111/j.1742-481X.2010.00739.x. [Epub ahead of print]

The objective of the study was to assess the cost-effectiveness of Vacuum Assisted Closure(®) (V.A.C.(®) ) Therapy compared with advanced wound care (AWC) for the treatment of diabetic foot ulcers (DFUs) in France. A cost-effectiveness model intended to reflect the management of DFUs was updated for the French setting. The Markov model follows the progression of 1000 hypothetical patients over a 1-year period. The model was populated with French-specific data, obtained from published sources and clinical experts. The analysis evaluated costs and health outcomes, in terms of quality-adjusted life-years (QALYs), wounds healed and amputations, from the perspective of the payer. The patients treated with V.A.C.(®) Therapy experienced more QALYs (0·787 versus 0·784) and improved healing rates (50·2% versus 48·5%) at a lower total cost of care (€24 881 versus €28 855 per patient per year) when compared with AWC. Sensitivity analyses conducted around key model parameters indicated that the results were affected by hospital resource use and costs. DFU treatment using V.A.C.(®) Therapy in France was associated with lower costs, additional QALYs, more healed ulcers and fewer amputations than treatment with AWC. V.A.C.(®) Therapy was therefore found to be the dominant treatment option.
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NewsBot · Dec 8, 2010

The clinical effectiveness of negative pressure wound therapy: a systematic review.
Xie X, McGregor M, Dendukuri N.
J Wound Care. 2010 Nov 10;19(11):490-495.

Objective: To estimate the efficacy of negative pressure wound therapy (NPWT), on the basis of a systematic review of reported randomised controlled trials (RCTs).

Method: A systematic literature search for relevant RCTs was carried out. The credibility of the outcome of each study was evaluated using a specially constructed instrument.

Results: We identified 17 RCTs, of which five had not been included in previous reviews or health technology assessments. For diabetic foot ulcers (seven RCTs), there was consistent evidence of the benefit of NPWT compared with control treatments. For pressure ulcers (three RCTs), results were conflicting. In trials involving mixed wounds (five RCTs), evidence was encouraging but of inadequate quality. Significant complications were not increased.

Conclusion: There is now sufficient evidence to show that NPWT is safe, and will accelerate healing, to justify its use in the treatment of diabetes-associated chronic leg wounds. There is also evidence, though of poor quality, to suggest that healing of other wounds may also be accelerated.
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Clinical experience of a new NPWT system in diabetic foot ulcers and post-amputation wounds.
Stansby G, Wealleans V, Wilson L, Morrow D, Gooday C, Dhatariya K.
J Wound Care. 2010 Nov 10;19(11):496-502.

Objective: The primary aim of this pilot observational study was to assess the reduction in wound depth and area achieved with a new negative pressure wound therapy (NPWT) system in diabetic patients with foot ulcers and post-amputation wounds. Secondary aims were to assess pain levels, extent of exudate removal, and ease of use of the system for both the patient and care giver.

Method: Patients in both acute and home care settings were enrolled into this 4-week study. Dressings were changed three times per week. Wound area and depth, exudate removal and pain severity were evaluated at each dressing change. At the final visit, the investigators and patients were surveyed with respect to equipment and dressings used in the study..

Results: Sixteen patients were enrolled into the study. Data relating to 14 patients with a variety of post-amputation wounds were included in the intention-to-treat (ITT) analysis. The post-amputation wounds showed a general trend for a reduction in the median wound surface area between baseline (22.9cm2; range 0.5-55) and the final visit (15.3cm2; range 2.4-63.5). This equates to a median change (calculated from the percentage change in wound area for each patient individually) of -41% (range -82% to +15%). There was also a general trend in reduction in the median depth between baseline (17mm; range 0-35) to final visit (5mm; range 0-35). One patient presented with a foot ulcer that demonstrated a 50% reduction in depth from baseline to the final assessment. The device effectively managed wound exudate and most patients reported low pain levels during therapy. Ease of use of the system was rated very highly by investigators and patients.

Conclusion: This pilot study indicates that the use of the new NPWT system can be expected to have a positive effect on the healing of post-amputation wounds and foot ulcers in patients with diabetes. The findings demonstrate that the system is easy to use, effectively controls exudate and minimises pain and inconvenience for patients being treated with NPWT
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NewsBot · Mar 4, 2011

Comparison of negative pressure wound therapy with an ultraportable mechanically powered device vs. traditional electrically powered device for the treatment of chronic lower extremity ulcers: A multicenter randomized-controlled trial.
Armstrong DG, Marston WA, Reyzelman AM, Kirsner RS.
Wound Repair Regen. 2011 Mar;19(2):173-80. doi: 10.1111/j.1524-475X.2010.00658.x.

The purpose of this study was to compare the ultraportable mechanically powered Smart Negative Pressure (SNaP(®) ) Wound Care System to the traditional electrically powered Vacuum-Assisted Closure (VAC(®) ) Therapy System in the treatment of chronic lower extremity wounds. This 12-center randomized-controlled trial of patients with noninfected, nonischemic, nonplantar lower extremity wounds had enrolled 65 patients, as of January 5, 2010, at the time of a planned interim analysis. Subjects were randomly assigned to treatment with either the SNaP(®) or VAC(®) Systems. The trial evaluated treatment for up to 16 weeks or till complete closure was achieved. Fifty-three patients (N=27 SNaP(®) , N=26 VAC(®) ) completed at least 4 weeks of therapy. Thirty-three patients (N=18 SNaP(®) , N=15 VAC(®) ) completed the study with either healing or 16 weeks of therapy. At the time of planned interim analysis, no significant differences (p=0.99) in the proportion of subjects healed between the two devices evaluated were found. In addition, the percent wound size reduction between treatment groups was not significantly different at 4, 8, 12, and 16 weeks, with noninferiority analysis at 4 weeks of treatment reaching the p-value <0.05 significance level ((*) p=0.019). These interim data suggest no difference in wound closure between the SNaP(®) System and the VAC(®) System in the population studied. We look forward to the final analysis results.
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NewsBot · Mar 5, 2011

A prospective study of negative pressure wound therapy with integrated irrigation for the treatment of diabetic foot ulcers.
Zelen CM, Stover B, Nielson D, Cunningham M.
Eplasty. 2011 Feb 16;11:e5.

Objective: Patients with diabetes often present with pedal wounds resistant to standard wound healing modalities and become chronic in nature. These chronic wounds in diabetic patients have a high incidence of complications including infection and amputation. Negative pressure wound therapy has been found to facilitate healing of the stagnant pedal wound. This protocol was designed to determine wound closure rates using a unique negative pressure wound therapy system that delivers vacuum-assisted wound closure with a simultaneous irrigation feature (Svedman Wound Treatment System).

Methods: A prospective single center study was conducted in adults with diabetic foot ulcers ≥cm(2) or more in size showing no signs of clinical infection, and having adequate blood flow. Patients received dressing changes and irrigation on a standard regimen with weekly wound assessments for a minimum of 6 weeks.

Results: 11 women and 8 men with a mean wound size of 2.4 cm × 2.2 cm were treated with the device. A total of 14 of /19 (74%) patients healed completely, with a median healing time of 34 days (range, 9-114). Eleven of 19 patients (58%) healed within the 6-week evaluation period. For the 5 patients who did not heal completely with the device, other treatments were utilized, including further wound debridement, muscle flaps, and skin grafting procedures.

Conclusions: Negative pressure wound therapy with integrated irrigation was well tolerated by the patients without complications related to the device application or irrigation feature. The data clearly suggests that this technology may be a promising alternative for the chronic nonhealing diabetic wound.
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NewsBot · Jun 19, 2011

Negative-Pressure Wound Therapy: Systematic Review of Randomized Controlled Trials
Dr. med. Peinemann, M.Sc., PD Dr. med. Sauerland, MPH
Dtsch Arztebl Int 2011; 108(22): 381-9

Background: In negative-pressure wound therapy (NPWT), a wound is covered with an airtight dressing, and negative pressure is applied. This is thought to promote healing. We evaluated NPWT with an updated, systematic review of the literature.

Methods: We systematically searched the PubMed and Cochrane Library databases for randomized, controlled trials (RCTs) of NPWT for the treatment of acute or chronic wounds. The primary outcome was complete wound closure.

Results: We found reports of 9 RCTs in addition to the 12 covered by earlier IQWiG reviews of this topic. Five of the 9 new trials involved NPWT systems that are not on the market. The frequency of complete wound closure is stated in only 5 of the 9 new reports; a statistically significant effect in favor of NPWT was found in only two trials.The results of 8 of the 9 new trials are hard to interpret, both because of apparent bias and because diverse types of wounds were treated.

Conclusion: Although there may be a positive effect of NPWT, we did not find clear evidence that wounds heal any better or worse with NPWT than with conventional treatment. Good RCTs are still needed to evaluate NPWT.
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NewsBot · Jun 23, 2011

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Negative-Pressure Wound Therapy: Systematic Review of Randomized Controlled Trials
Dr. med. Peinemann, M.Sc., PD Dr. med. Sauerland, MPH
Dtsch Arztebl Int 2011; 108(22): 381-9
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Press release:
No Healing in a Vacuum

Negative-pressure wound therapy probably does not promote healing. This is the conclusion of Frank Peinemann and Stefan Sauerland’s meta-analysis in the current edition of Deutsches Ärzteblatt International (Dtsch Arztebl Int 2011; 108[22]: 381-9).

In negative-pressure wound therapy (NPWT), wounds are covered with an airtight film and an adjustable negative pressure is applied using an electronically controlled pump. The negative pressure drains wound exudate and is thought to promote healing. This procedure is used in particular for chronic persistent wounds and complicated wounds.

The research included a total of 21 randomized controlled trials that reported on commercially available NPWT systems and systems not commercially available. The proportion of patients with complete wound closure was reported in only five trials, and only two showed a statistically significant effect in favor of NPWT. The results on complete wound closure are not homogenous, and as yet it cannot be concluded that NPWT is superior to the control treatment.
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NewsBot · Sep 7, 2011

Press Release:
KCI's V.A.C.Via(TM) Therapy System Named a Leading Innovation by Podiatry Today

Kinetic Concepts, Inc. KCI -0.06% today announced that its V.A.C.Via(TM) Therapy System was named one of the "Top Ten Innovations in Podiatric Technology" by trade publication Podiatry Today.

Podiatry Today ranked V.A.C.Via(TM) second among innovative devices for its quarter-sized, virtually silent pump that makes it a patient-friendly treatment option. The publication also recognized V.A.C.Via(TM) System's seven-day performance on one battery charge, as opposed to heavy NiCd rechargeable batteries found in other NPWT devices, as another factor leading to its innovative ranking.

The V.A.C.Via(TM) Therapy System is a next-generation negative pressure wound therapy (NPWT) solution that offers clinicians and patients an off-the-shelf, portable healing technology that delivers all of the benefits of V.A.C.(R) Therapy. The technology provides a wound healing environment for low- to moderate-exudating wounds while offering simplicity, mobility and convenience to both physicians and patients.

"Miniaturizing V.A.C.(R) Therapy in the form of the V.A.C.Via(TM) System ensures trusted, cost-effective outcomes with added mobility," said Mike Genau, global president, KCI's Active Healing Solutions(TM). "Helping patients return to their normal routine, while receiving world-class wound care takes industry leading research and developers who put patients first -- that is at the heart of what we do at KCI."

The publication also highlights the V.A.C.Via(TM) System's small size, light weight and portability, with one physician remarking that it can be discreetly attached to a patient's waist throughout the duration of treatment, then recycled or disposed of by the patient at the end of seven days.
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NewsBot · Sep 15, 2011

Negative pressure wound therapy in patients with diabetic foot.
Ulusal AE, Sahin MS, Ulusal B, Cakmak G, Tuncay C.
Acta Orthop Traumatol Turc. 2011 July-August;45(4):254-260.

OBJECTIVE:
In this study our aim was to compare the results of standard dressing treatment to negative pressure wound therapy (NPWT) performed with a vacuum-assisted closure (VAC) device in patients with diabetic foot ulcers.

METHODS:
We assessed the results of 35 patients treated for diabetic foot ulcer between 2006 and 2008. Of these cases, 20 (4 women and 16 men; mean age: 66 years; range: 52-90 years) were treated with standard wet dressings and 16 feet in 15 patients (10 men, 5 women; mean age: 58.9 years; range: 42-83 years) with VAC therapy. The success of treatment was evaluated in terms of hospitalization length and rate of limb salvation.

RESULTS:
The average hospitalization period with VAC treatment was 32 days compared to 59 days with standard dressing treatment. All patients treated with standard dressings eventually had to undergo amputation. However, the amputation rate was 37% in the VAC treated group and 88% of patients had a functional extremity at the end of treatment.

CONCLUSION VAC therapy, together with debridement and appropriate antibiotic therapy, enables a higher rate of limb salvage, especially in Wagner Grade 3 and Grade 4 ulcers.
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NewsBot · Oct 25, 2011

Role of negative pressure wound therapy in healing of diabetic foot ulcers.
Nain PS, Uppal SK, Garg R, Bajaj K, Garg S.
J Surg Tech Case Rep. 2011 Jan;3(1):17-22.

INTRODUCTION:
Foot disorders such as ulceration, infection and gangrene are the most common, complex and costly sequelae of diabetes mellitus.[1-3] Even for the most superficial wounds, treatment is often difficult with poor healing responses and high rates of complications. The purpose of this study is to compare the rate of ulcer healing with the negative pressure dressing technique to conventional moist dressings in the treatment of diabetic foot ulcers.

MATERIALS AND METHODS:
The study was conducted on 30 patients, which were divided into two groups. One group received negative pressure dressing while other group received conventional saline moistened gauze dressing. Results were compared for rate of wound healing.

RESULTS:
There was a statistically significant difference in the rate of appearance of granulation tissue between the two groups; with granulation tissue appearing earlier in the study group. The study group promised a better outcome (80% complete responders) as compared to the control group (60% complete responders).

CONCLUSIONS:
Negative pressure wound therapy has a definitive role in healing of diabetic foot ulcers.
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NewsBot · Nov 4, 2011

Maintenance of negative-pressure wound therapy while undergoing hyperbaric oxygen therapy.
Chong SJ, Kwan TM, Weihao L, Joang KS, Rick SC.
Diving Hyperb Med. 2011 Sep;41(3):147-50.

BACKGROUND:
Both negative wound pressure therapy (NPWT) and hyperbaric oxygen therapy (HBOT) are useful modalities in the treatment of problem wounds. However, none of the commercially available portable negative-pressure devices have been certified safe for use in a recompression chamber. Thus, the NPWT device is removed while the patient undergoes HBOT. The purpose of this study is to demonstrate that wound negative pressure can be effectively and safely maintained during HBOT.

PATIENTS AND METHODS:
In a small, prospective, randomised crossover trial, we used commonly available clinical materials to connect the NPWT suction tubing to the negative suction generating device in the hyperbaric chamber. Six patients each underwent one HBOT session with continuous NPWT and one HBOT session without concurrent NPWT. We assessed the patient's pain score, the amount of exudate aspirated by the NPWT during HBOT, and the appearance of the wound dressing after each session was assessed in a blinded manner.

RESULTS:
There were no differences in pain scores between the two HBOT sessions. The amount of exudate aspirated during HBOT with NPWT ranged from 5 to 12 ml. Five of the six patients had a better appearance scoring of their dressing when NPWT was maintained during HBOT (P = 0.006).

CONCLUSION:
We successfully demonstrated a simple design that allows the maintenance of NPWT during HBOT without causing additional pain, and with continued extraction of exudate. The maintenance of NPWT during HBOT also allowed the dressing to be maintained undisturbed.
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NewsBot · Nov 28, 2011

This clinical trial has just been registered:
Treatment Study of Negative Pressure Wound Therapy for Diabetic Foot Wounds (DiaFu)

On behalf of a consortium of 19 health insurance companies the Institute for Research in Operative Medicine as part of the University of Witten / Herdecke gGmbH is planning and conducting a clinical study evaluating the efficacy and effectiveness of negative pressure wound therapy in the treatment of wound healing disorders of the foot, which are caused by diabetes mellitus.

This german multicenter study is due to evaluate whether the negative pressure wound therapy or the control therapy (standard wound therapy following the guidelines) is superior.

Patients will be randomly assigned to the two study arms. Both patients and the treatment staff know about the specific allocation to the negative pressure wound therapy or standard wound therapy arm.

A photo documentation and a computer-based evaluation of the wound images will be performed. This is done centrally by independent examiners, who don`t know neither the patient nor the treatment assignment.

It is believed that the application of the negative pressure wound therapy systems compared to standard therapy of diabetic foot wounds will lead more frequent and more rapid to the achievement of complete wound closure and that the use of negative pressure wound therapy is an effective and safe therapy option for the treatment of diabetic foot wounds in inpatient and outpatient care.

Patient´s to be included into the study should have either a chronic diabetic foot wound existing longer than 6 weeks whereas dead tissue components must be completely removed by the doctor or a wound after amputation of foot parts.

The study treatment may have already started in the hospital if applicable. The further wound treatment will be mainly performed within outpatient care. Study Participants will return to the study centre for regular study visits or even for wound treatment.

The comparison of the outcomes of both study arms will give valuable information about the efficacy of negative pressure wound therapy in inpatient as well as outpatient care. These results should be provided until the end of 2014 as a basis for the decision of the Federal Joint Committee to answer the question if the negative pressure wound therapy can be approved as a standard service for reimbursement by health insurance companies.
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NewsBot · Nov 29, 2011

Evidence-based recommendations for the use of negative pressure wound therapy in chronic wounds: Steps towards an international consensus.
Vig S, Dowsett C, Berg L, Caravaggi C, Rome P, Birke-Sorensen H, Bruhin A, Chariker M, Depoorter M, Dunn R, Duteille F, Ferreira F, Francos Martínez JM, Grudzien G, Hudson D, Ichioka S, Ingemansson R, Jeffery S, Krug E, Lee C, Malmsjo M, Runkel N; International Expert Panel on Negative Pressure Wound Therapy [NPWT-EP], Martin R, Smith J.
J Tissue Viability. 2011 Nov 24.

AIM:
Negative Pressure Wound Therapy (NPWT) has become widely adopted over the last 15 years and over 1000 peer-reviewed publications are available describing its use. Despite this, there remains uncertainty regarding several aspects of usage. In order to respond to this gap a global expert panel was convened to develop evidence-based recommendations describing the use of NPWT. In this communication the results of the study of evidence in chronic wounds including pressure ulcers, diabetic foot ulcers (DFU), venous leg ulcers (VLU), and ischaemic lower limb wounds are reported.

METHODS:
Evidence-based recommendations were obtained by a systematic review of the literature, grading of evidence, drafting of the recommendations by a global expert panel followed by a formal consultative consensus development program in which 422 independent healthcare professionals were able to agree or disagree with the recommendations. The criteria for agreement were set at 80% agreement. Evidence and recommendations were graded according to the SIGN (Scottish Intercollegiate Guidelines Network) classification system.

RESULTS:
The primary treatment goal of NPWT in most chronic wounds is to achieve wound closure (either by secondary intention or preparing the wound for surgical closure). Secondary goals commonly include: to reduce wound dimensions, and to improve the quality of the wound bed. Thirteen evidence based recommendations were developed in total to address these treatment goals; 4 for pressure ulcers, 4 for DFU, 3 for ischaemic lower limb wounds and 2 for VLU.

CONCLUSION:
The present evidence base is strongest for the use of NPWT in non-ischaemic DFU and weakest in VLU. The development of evidence-based recommendations for NPWT with direct validation from a large group of practicing clinicians offers a broader basis for consensus than work by an expert panel alone.
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NewsBot · Dec 24, 2011

Vacuum assisted closure improves the quality of life in patients with diabetic foot.
Karatepe O, Eken I, Acet E, Unal O, Mert M, Koc B, Karahan S, Filizcan U, Ugurlucan M, Aksoy M.
Acta Chir Belg. 2011 Sep-Oct;111(5):298-302.

BACKGROUND:
Diabetes Mellitus (DM) is the most common endocrine disease worldwide. One of the most important chronic complications of this disease is the development of diabetic foot. The management of diabetic foot wounds is quite important with respect to public health.

AIMS:
To determine the effect of Vacuum Assisted Closure (VAC) therapy on the quality of life in the treatment of diabetic foot ulcers and compare it with standart wound care.

METHODS:
Between May 2007 to December 2008, 67 consecutive patients with diabetic foot ulcers were randomly assigned to VAC therapy (Group 1, n : 30) or standart wound care (Group 2, n : 37). The SF-36 questionnaire was administered the day before and in the month following wound healing. Global analyses of the 8 domains and 2 comprehensive indexes of SF-36, Physical Component Summary (PCS) and Mental Component Summary (MCS) were performed. Clinical measures included standard antidiabetic treatment, daily wound care including antiseptic bath, debridement, toe removal for gangrene when necessary, and wound care with conventional methods or VAC. Healing time was calculated as the time from hospital admission to the time of re-epithelization.

RESULTS:
There were no differences in the mean age, ulcer size and pulse status of the patients in both groups. Healing time in the VAC group was significantly reduced (p < 0.05). All 8 domains of SF-36 and MCS and PCS scores improved remarkably after VAC therapy.

CONCLUSION:
Vacuum Assited Closure therapy was found to be effective in the treatment of chronic diabetic ulcers. The improvement of quality of life demonstrates a clear-cut indication in this particular group of patients.
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NewsBot · May 18, 2012

Negative pressure therapy: theory and practice.
Schintler MV.
Diabetes Metab Res Rev. 2012 Feb;28

Negative pressure (wound) therapy, synonymous with topical negative pressure or vacuum therapy mainly cited as branded VAC® (vacuum-assisted closure) therapy, is a mode of therapy used to encourage wound healing. It is used both as primary treatment of chronic and complex wounds and as an adjunct for temporary closure and wound bed preparation preceding surgical procedures such as skin grafts and flap surgery. The device has come into wide and successful use, although the physiological basis of its effect is not yet fully understood, and with a delay, increasingly evidence-based data become available. A meta-analysis was made of peer-reviewed publications (PubMed-Medline) chosen on the basis of inclusion of the terms randomized clinical trial, vacuum-assisted closure, and topical negative pressure. Scientific data were evaluated from experimental animal studies, randomized clinical trials, observations of clinical applications, and case reports on all known effects of VAC therapy. Systematic analysis of the data shows efficacy concerning induction of wound healing mechanisms, especially in the early stage. Increased perfusion can be considered proven. Data analysis shows positive efficacy for treatment of infection. Although this therapy appears effective and its superiority to conventional techniques has been demonstrated, there are still some critical votes concerning efficacy. Because its mechanisms of action remain unclear, and because there is still some gap between evidence-based data and the excellent clinical results, further prospective, randomized, blinded studies are needed. Even so, we conclude that vacuum therapy, used when indicated and especially by experienced surgeons, is an excellent tool to support wound healing.
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NewsBot · May 23, 2012

Press Release:
Clinical data indicates PICO™ NPWT System reduces healing time and increases patient comfort

Smith & Nephew (LSE: SN, NYSE: SNN), the global medical technology business, today announces preliminary independent data showing that patients using the PICO™ Negative Pressure Wound Therapy (NPWT) System experienced reduced healing times, a higher degree of conformability, increased comfort and greater ease to use over conventional NPWT. These outcomes demonstrate how appropriately designed products such as PICO™ can improve patient wellbeing and further help reduce the human and economic cost of wounds.

Theresa Hurd, RN, MSN, MEd, will be presenting these results at the European Wound Management Association (EWMA) annual conference in Vienna on Wednesday, 23 May 2012 (12:30-13:30 in Room E1). Ms. Hurd is one of the authors of the study “Outcomes of a Portable Single Use Negative Pressure Device Trial.”

“The objective of the study was to determine what was required to introduce a new innovation in the community-based setting. Indicators we measured were healing ability, patient comfort and ease of use for the clinicians,” said Hurd. “What we found was that we were able to transition NPWT patients from acute care and keep them on NPWT longer in a cost-efficient way. We were astounded to find that the savings were in the thousands of dollars per treatment, per patient. Patient feedback on how PICO™ was able to improve their quality of life and feeling of wellbeing was resoundingly positive. They loved the size and discreetness of the system and the ease of dressing changes.1”

A total of 198 patients in a Canadian Community Care Access Centre and Acute Care Hospitals were evaluated during a six-month period for this independent clinical study. Ninety percent of patients reported that the conformability of PICO™ was good, and 81% reported that they were pleased with the system. It was also described as significantly easier to use than conventional NPWT. The trial focused on several types of wounds, including surgical wounds and venous leg ulcers.

“The innovation of PICO™ has expanded patient access to the benefits of NPWT through a single use system and demonstrates our commitment to advancing wound care technology,” said Andy Boyes, President, Europe, for the Advanced Wound Management division of Smith & Nephew. “When developing the system, as with everything we do, we sought to reduce the human and economic cost of wounds. PICO™ simplifies delivery of the proven benefits of traditional NPWT on small to medium wounds, making the treatment more affordable and cost-predictive.”

In addition to its PICO™ system and spearheading research to advance NPWT, Smith & Nephew has also recently acquired Kalypto Medical, a medical device company in the U.S., further building on its investment and commitment in NPWT.
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NewsBot · Jun 29, 2012

Use of negative pressure wound therapy to help facilitate limb preservation.
Armstrong DG, Andros G.
Int Wound J. 2012 Aug;9 Suppl 1:1-7.

Because of changes in demography, non-communicable diseases cause more deaths worldwide than infectious disease for the first time in history. One of the most prevalent of these maladies is diabetes mellitus, which resulted in 4·6 million deaths in 2011. There will be approximately 552 million people with diabetes worldwide by 2030. For these patients, one of the most common severe complications will be a foot wound. Patients with diabetes have at least a 25% lifetime risk of developing a foot ulcer. Many of these infections go on to amputation. Those patients have a 50% mortality rate in the 5 years following the initial amputation. Indeed, these problems are costly as well. In 2010, spending on diabetes was estimated to account for 11·6% of the total health care expenditure in the world. This review merges scientific evidence with expert experience to show the role of negative pressure wound therapy using reticulated open cell foam (V.A.C.® Therapy, KCI USA, Inc., San Antonio, TX) in limb preservation
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NewsBot · Aug 1, 2012

Podiatry Today just published this review:
A Guide To Current And Emerging NPWT Modalities

Negative pressure wound therapy

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