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From the American Diabetes Association conference (reported by DocGuide): Wound Duration Not a Deterrent for Negative Pressure Wound Therapy:
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WASHINGTON DC -- June 12, 2006 -- Wound chronicity should not rule out the use of negative pressure wound therapy (NPWT) to treat complex diabetic foot wounds, according to research findings presented here at the American Diabetes Association 66th Scientific Sessions (ADA).
Before the present investigation, large, acute wounds had not been evaluated in randomised clinical trials.
David Armstrong, DPM, PhD, director, Center for Lower Extremity Research, Rosalind Franklin University of Medicine, North Chicago, Illinois, and colleagues evaluated the proportion and rate of healing in acute and chronic wounds after partial foot amputation in patients with diabetes treated with NPWT using vacuum assisted closure or standard wound therapy (SWT).
The trial included 162 patients who were 18 years of age or older and had a diabetic foot amputation up to the transmetatarsal level and evidence of adequate perfusion.
Overall, patients were randomised to NPWT or SWT with alginates, hydrocolloids, foams, or hydrogels according to standardised guidelines. All patients received off-loading therapy.
Wounds were treated until closure or until the completion of the 112-day active treatment phase. Complete wound closure was defined as 100% re-epithelialisation without drainage.
This trial evaluated a significantly higher proportion of acute wounds (SWT=59 NPWT=63) than chronic wounds (SWT=26, NPWT=14; P = .001).
Results showed faster healing in the NPWT group in both acute (P = .030) and chronic wounds (P = .033).
Overall, the results demonstrate that among patients treated with NPWT via vacuum assisted closure, there was not a significant difference in wound healing as a function of chronicity and also that NPWT was superior to SWT in both groups, Dr. Armstrong said during a presentation on June 10th.
The researchers concluded that this approach can be used effectively on both acute and chronic diabetic foot amputation wounds.
Diabetics are estimated to have a 15% lifetime risk of developing foot ulcers, with some estimates showing that lifetime incidence rate may be as high as 25%. Consequently, diabetes is a leading cause of nontraumatic lower-extremity amputations in the U.S.
Negative pressure wound therapy to treat hematomas and surgical incisions following high-energy trauma. J Trauma. 2006 Jun;60(6):1301-6
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PURPOSE:: To evaluate the use of negative pressure wound therapy (NPWT) to augment healing of surgical incisions and hematomas after high-energy trauma.
MATERIALS:: This study is a prospective randomized evaluation of NPWT in trauma patients, randomizing patients with draining hematomas to either a pressure dressing (group A) or a VAC (group B). Additionally, patients with calcaneus, pilon, and high-energy tibial plateau fractures were randomized to either a standard postoperative dressing or a VAC over the sutures.
RESULTS:: There were 44 patients randomized into the hematoma study. Group A drained a mean of 3.1 days, compared with only 1.6 days for group B. This difference was significant (p = 0.03). The infection rate for group A was 16%, compared with 8% in group B. An additional 44 patients have been randomized into the fracture study. Again, a significant difference (p = 0.02) was present when comparing drainage in group A (4.8 days) and group B (1.8 days). No significant difference was present at current enrollment for infection or wound breakdown.
DISCUSSION:: NPWT has been used on many complex traumatic wounds. Potential mechanisms of action include angiogenesis, increased blood flow, and decreased interstitial fluid. This ongoing randomized study has demonstrated decreased drainage and improved wound healing following both hematomas and severe fractures.
Press release: Panel of Experts Updates Guidelines for Use of KCI's V.A.C.(R) Therapy on the Diabetic Foot
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Opinion Leaders Provide Current Clinical Evidence and Best Practices around Application of Vacuum Assisted Closure(R) Therapy
Kinetic Concepts, Inc. (NYSE: KCI), a global medical technologycompany with leadership positions in advanced wound care andtherapeutic surfaces, today announced the publication of new clinicalguidelines around the use of KCI's Vacuum Assisted Closure(R) orV.A.C.(R) Therapy in the treatment of the diabetic foot. The newguidelines were published by a multidisciplinary panel of experts at aconsensus conference held in February 2006 in Miami, and are intendedto update the findings presented in the 2004 guidelines from theTucson Expert Consensus Conference (TECC) on V.A.C.(R) Therapy.Specifically, the latest guidelines weigh the most current clinicalevidence, refute or confirm current consensus, provide practicalclinical guidance and best practices to clinicians treating diabeticfoot wounds, and help to direct future research.
The original TECC guidelines published in 2004 were a significantstep in establishing V.A.C.(R) Therapy as a standard of care to helppromote wound healing in the diabetic foot. The 2006 Miami updates addto a growing base of clinical evidence, which now includes severalrandomized controlled trials and numerous published clinical studiesand abstracts supporting its clinical efficacy. Specifically, theMiami consensus panel discussed and lent comment on a series ofquestions relating to the application and usage of V.A.C. (R) Therapy.
"It was a pleasure participating in this outstanding programevaluating a promising modality amongst such a distinguished group ofclinician-scientists," said David G. Armstrong, Professor of Surgery,Chair of Research and Assistant Dean of the Dr. William M. SchollCollege of Podiatric Medicine at Rosalind Franklin University ofMedicine and Science in Chicago, Illinois. Dr. Armstrong served asChair of this interdisciplinary panel. "As with the TECC panel in2004, this group of leading clinician-scientists was convened underthe shared objective of evaluating and assembling the latest clinicalevidence. And I believe I speak for the consensus panel when I saythat the evidence presented in Miami further assists in improvingcare. Clearly, there is a vibrant, ongoing dialogue happening amongpracticing clinicians and academia that suggests that this technologyholds great potential in the treatment of these most complexpatients."
General consensus, as presented in the updated guidelines:
-- V.A.C.(R) Therapy is rapidly becoming a standard of care for complex diabetic foot wounds, and can be used in conjunction with a variety of other advanced wound care modalities;
-- Optimal use of this modality helps convert complex wounds into more manageable wounds;
-- Combining V.A.C.(R) Therapy with adequate offloading and debridement can yield consistently positive results.
KCI's Medical Director, Dr. Adrianne "Patti" Smith added,"Consensus offered by this esteemed group further elevates KCI'sV.A.C.(R) Therapy as an important addition to wound managementstrategies for complex diabetic foot wounds, and builds on the body ofresearch brought to light in the 2004 guidelines. Incidence ofdiabetic foot wounds is on the rise worldwide and this upswing islikely to continue. More than ever, it is critical to keep current thesort of informed perspective that will drive appropriate use whiledelivering enhanced wound healing with KCI's V.A.C.(R) TherapySystem."
The consensus document was published in each of the following HMPCommunications' publications as a special supplement: the June 2006issues of WOUNDS and Ostomy/Wound Management, and the July 2006 issuesof Podiatry Today, and Vascular Disease Management. To obtain theConsensus document in full, please contact a local KCI representativeat 1-877-WOUNDVAC. The Consensus conference was sponsored by an educational grantfrom KCI and authored by independent clinical experts and thoughtleaders. Some of the information represents the views and opinions ofthese experts based on their practice and expertise. The guidelinesgenerally discuss the benefits of normal healing and specificindications for use, and KCI encourages the clinician to consultspecific indications, contraindications, warnings and precautions fromthe V.A.C.(R) Therapy Clinical Guidelines, product literature andInstructions for Use prior to application.
Negative pressure wound therapy via vacuum-assisted closure following partial foot amputation: what is the role of wound chronicity?
Armstrong DG, Lavery LA, Boulton AJ. Int Wound J. 2007 Mar;4(1):79-86.
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Randomised clinical trials (RCTs) to evaluate diabetic foot wound therapies have systematically eliminated large acute wounds from evaluation, focusing only on smaller chronic wounds. The purpose of this study was to evaluate the proportion and rate of wound healing in acute and chronic wounds after partial foot amputation in individuals with diabetes treated with negative pressure wound therapy (NPWT) delivered by the vacuum-assisted closure (VAC((R))) device or with standard wound therapy (SWT). This study constitutes a secondary analysis of patients enrolled in a 16-week RCT of NPWT: 162 open foot amputation wounds (mean wound size = 20.7 cm(2)) were included. Acute wounds were defined as the wounds less than 30 days after amputation, whereas chronic wounds as the wounds greater than 30 days. Inclusion criteria consisted of individuals older than 18 years, presence of a diabetic foot amputation wound up to the transmetatarsal level and adequate perfusion. Wound size and healing were confirmed by independent, blinded wound evaluators. Analyses were done on an intent-to-treat basis. There was a significantly higher proportion of acute wounds (SWT = 59; NPWT = 63) than chronic wounds (SWT = 26; NPWT = 14), evaluated in this clinical trial (P = 0.001). There was no significant difference in the proportion of acute and chronic wounds achieving complete wound closure in either treatment group. Despite this finding, the Kaplan-Meier curves demonstrated statistically significantly faster healing in the NPWT group in both acute (P = 0.030) and chronic wounds (P = 0.033). Among the patients treated with NPWT via the VAC, there was not a significant difference in healing as a function of chronicity. In both the acute and the chronic wound groups, results for patients treated with NPWT were superior to those for the patients treated with SWT. These results appear to indicate that wound duration should not deter the clinician from using this modality to treat complex wounds.
A comparison of diabetic foot ulcer outcomes using negative pressure wound therapy versus historical standard of care.
Lavery LA, Boulton AJ, Niezgoda JA, Sheehan P. Int Wound J. 2007 Jun;4(2):103-13.
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Diabetic foot ulcers (DFUs) are a leading cause of morbidity and hospitalisation among patients with diabetes. We analysed claims data for Medicare part B diabetic foot ulcer patients treated with Negative Pressure Wound Therapy at home (N = 1135) and diabetic foot ulcer patients from a published meta-analysis of randomised controlled wet-to-moist therapy. The expected costs of care for the two treatments were also compared. A significantly greater proportion of wounds treated with NPWT achieved a successful treatment endpoint compared with wet-to-moist therapy at both 12 weeks (39.5% versus 23.9%; P < 0.001) and 20 weeks (46.3% versus 32.8%; P < 0.001). NPWT-treated patients reached a successful wound treatment endpoint more rapidly, and the benefit was apparent in all wound sizes. Expected 20-week treatment costs for NPWT were similar to those for wet-to-moist therapy if one nursing visit per day for the latter is assumed but 42% less if two nursing visits per day are made. Thus, NPWT may improve the proportion of DFUs that attain a successful wound treatment endpoint and decrease resource utilisation by a given health care system compared with standard wet-to-moist therapy
Topical Negative Pressure, Or VAC Therapy For Wound Healing Questioned
Medical News Today are reporting: Topical Negative Pressure, Or VAC Therapy For Wound Healing Questioned31 Jul 2007
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How effective and useful VAC Therapy, or Topical Negative Pressure is in the treatment of long-term wounds is questioned in an article in this month's Drug and Therapeutics Bulletin (DTB). This treatment has become progressively more popular.
Topical Negative Pressure involves placing a foam dressing, cut to shape, into the wound. A tube is attached to the foam with a suction device, at the other end the tube is attached to a canister. The whole area is then sealed with a sticky film.
This therapy is said to accelerate healing by increasing oxygen flow to the wound, cleansing the area of harmful bacteria and other substances that may slow wound healing down, and raise the production of chemicals that encourage tissue growth. This treatment is used for pressure ulcers (bed sores), diabetic foot ulcers, skin grafts and venous ulcers.
However, the authors of this report have concluded that "the clinical effectiveness of this therapy is unclear," after reviewing the available evidence. They comment that several studies done on the use of this technique were flawed in such a way as to "cast doubt on the validity and reliability of the results."
None of the evidence is compelling enough to show that this technique helps bed sores or uncomplicated diabetic foot ulcers heal more quickly, or that it aids skin grafts to 'take', say the researchers.
Where faster healing may take place the circumstances and setting are uncommon. For example, the patients with venous ulcers who receive this treatment and get plenty of bed rest in hospital may benefit. However, the authors say such patients are hardly ever treated in this way as it is very expensive.
The article adds that the evidence that this technique is good value for money is also lacking. The rental of a suction unit in the UK costs about £39 ($78) a day. The dressing has to be changed every 48 hours at £50 ($100) a go.
News Release KCI Announces Early Success in Global Launch of Next Generation InfoV.A.C.(R) Therapy System
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SAN ANTONIO--(BUSINESS WIRE)--Aug. 14, 2007--Kinetic Concepts, Inc. (NYSE:KCI), a leading global advanced wound care and therapeutic surfaces company, today announced initial favorable results from customer placements of its next generation V.A.C.(R) Therapy System - InfoV.A.C.(R) As a part of the launch process, customers evaluated the therapy's enhanced capabilities, which include intuitive, easy-to-use operating features designed to simplify training and improve patient compliance. Caregiver response has been favorable, and the new system received high ratings in post-launch customer surveys.
KCI's new InfoV.A.C.(R) Therapy System enhancements were based largely on "Voice of the Customer" input from patients and caregivers. "Time is critical for patients and nurses, and the Seal Check(TM) feature saves time in trying to achieve a seal," said Sue Mendez-Eastman, RN, Certified Wound Nurse and a key opinion leader in the area of advanced wound care. "The Digital Wound Image Analysis feature helps in the documentation of wound healing and facilitates the dissemination of wound information among multi-disciplinary teams. Also, InfoV.A.C.(R)'s compact design works really well in a patient room that is already cluttered with so much equipment," Mendez-Eastman added.
"V.A.C.(R) Therapy continues to be accepted as an excellent option for the treatment of complex and even life-threatening wounds," said Catherine M. Burzik, President and Chief Executive Officer of KCI. "By improving patient compliance and ensuring optimal delivery of NPWT, the InfoV.A.C.(R) Therapy System will improve upon the already outstanding outcomes for which V.A.C.(R) Therapy is recognized globally."
V.A.C.(R) Therapy's clinical benefits and economic value are supported by an extensive body of medical evidence including 14 randomized controlled trials, more than 350 peer-reviewed publications and references in more than 50 medical text books. Most recently, KCI announced the results of the largest randomized controlled trial on the use of V.A.C.(R) Therapy in the treatment of the diabetic foot. The study involved 335 patients across 37 participating centers and demonstrated that V.A.C.(R) Therapy significantly increased the number of wounds achieving complete closure as well as a reduction in the time required to achieve wound healing. Since its introduction, V.A.C.(R) Therapy has treated approximately 2 million patients with more than 23 million therapy-days. It is the only NPWT offering specifically cleared by the FDA for all care settings, including the home.
About KCI
Kinetic Concepts, Inc. is a global medical technology company with leadership positions in advanced wound care and therapeutic surfaces. We design, manufacture, market and service a wide range of proprietary products that can improve clinical outcomes and can help reduce the overall cost of patient care. Our advanced wound-care systems incorporate our proprietary Vacuum Assisted Closure(R), or V.A.C.(R) Therapy technology, which has been demonstrated clinically to help promote wound healing through unique mechanisms of action and can help reduce the cost of treating patients with serious wounds. Our therapeutic surfaces, including specialty hospital beds, mattress replacement systems and overlays, are designed to address pulmonary complications associated with immobility, to prevent skin breakdown and assist caregivers in the safe and dignified handling of obese patients. We have an infrastructure designed to meet the specific needs of medical professionals and patients across all health care settings, including acute care hospitals, extended care organizations and patients' homes, both in the United States and abroad.
Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding the clinical evidence relating to V.A.C.(R) Therapy and the potential impact of the launch of the InfoV.A.C.(R) Therapy System and customer preference. These forward-looking statements are based on our current expectations and are subject to a number of risks and uncertainties. All information set forth in this release is as of its date, and we undertake no duty to update this information. More information about the company is described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2006 and our Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2007, on file with the SEC and available at the SEC's website at www.sec.gov.
Negative-Pressure Wound Therapy and Diabetic Foot Amputations
A Retrospective Study of Payer Claims Data
Robert G. Frykberg, DPM, MPH and David V. Williams, BA J Am Podiatr Med Assoc 97(5): 351–359, 2007
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Background: This study was undertaken to assess the benefits of negative-pressure wound therapy (NPWT) versus traditional wound therapies in reducing the incidence of lower-extremity amputations in patients with diabetic foot ulcers.
Methods: Administrative claims data for patients with diabetic foot ulcers from commercial payers (n = 3,524) and Medicare (n = 12,795) were retrospectively analyzed. Patients were divided into NPWT and control/traditional therapy groups on the basis of administrative codes. Risk-adjustment procedures were then performed to match patient risk categories (through total treatment costs) and wound severities (through debridement depth).
Results: The incidence of amputations in the NPWT groups was lower than that in the control groups. For the cost-based risk-adjustment analysis, amputation incidences with NPWT versus traditional therapy were 35% lower in the Medicare sample (10.8% versus 16.6%; P = .0077) and 34% lower in the commercial payer sample (14.1% versus 21.4%; P = .0951). Whereas overall amputation rates increased progressively with increasing wound debridement depth in both control groups, the same increasing trend did not occur in the NPWT groups.
Conclusions: Patients with diabetic foot ulcers in the Medicare sample treated with NPWT had a lower incidence of amputations than those undergoing traditional wound therapy; this finding was evident in wounds of varying depth in both populations studied.
Johnson and Johnson have just been granted a new patent on a wound dressing for vacuum therapy that was filed Dec 2006:
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Abstract
A wound dressing for vacuum therapy comprising: a cover configured for placement over the wound to maintain a reduced pressure over the wound and adapted for communication with a source of vacuum, and a screen structure for placement between the cover and the wound, wherein the screen structure is adapted to remove or inactivate undesirable components from the wound environment and/or to concentrate desirable components present in the wound environment. Also provided are kits for the assembly of such wound dressings, and systems comprising the wound dressings in combination with a source of vacuum.
Wounds have just released the full text of this: Negative Pressure Wound Therapy on Diabetic Foot Ulcers
Abdullah Etoz, MD and Ramazan Kahveci, MD
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The effects of negative pressure wound therapy ([NPWT], V.A.C.® Therapy, KCI, San Antonio, Tex) were compared with standard dressings in 45 patients with diabetic foot ulcers who were admitted to the Department of Plastic and Reconstructive Surgery, Medical Park Hospital, Bursa, Turkey. Twenty-four patients were randomly divided into 2 groups—NPWT group and control group. Initially, the mean surface area of wounds in the NPWT group was 109 cm2, the control group 94.8 cm2. The mean duration of open wound care was 11.25 days in the NPWT group and 15.75 days in the control group (P =0.05). After wound management, mean surface area of the diabetic wounds was 88.6 cm2 in the NPWT group, and 85.3 cm2 in the control group (P < 0.05). The use of NPWT may be an effective initial wound therapy to achieve faster wound bed granulation in diabetic foot ulcers. Further studies are needed to clarify the effects and indications and to modify the technique of this alternative treatment for use on nonhealing wounds.
Effects of vacuum-compression therapy on healing of diabetic foot ulcers: Randomized controlled trial.
Akbari A, Moodi H, Ghiasi F, Sagheb HM, Rashidi H. J Rehabil Res Dev. 2007;44(5):631-6.
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A single-blind, randomized controlled trial was conducted to evaluate vacuum-compression therapy (VCT) for the healing of diabetic foot ulcers. Eighteen diabetic patients with foot ulcers were recruited through simple nonprobability sampling. Subjects were randomly assigned to either an experimental or a control group. Before and after intervention, the foot ulcer surface area was estimated stereologically, based on Cavalieri's principle. The experimental group was treated with VCT in addition to conventional therapy for 10 sessions. The control group received only conventional therapy, including debridement, blood glucose control agents, systemic antibiotics, wound cleaning with normal saline, offloading (pressure relief), and daily wound dressings. The mean foot ulcer surface area decreased from 46.88 +/- 9.28 mm(2) to 35.09 +/- 4.09 mm(2) in the experimental group (p = 0.006) and from 46.62 +/- 10.03 mm(2) to 42.89 +/- 8.1 mm(2) in the control group (p = 0.01). After treatment, the experimental group significantly improved in measures of foot ulcer surface area compared with the control group (p = 0.024). VCT enhances diabetic foot ulcer healing when combined with appropriate wound care.
Thromboangiitis obliterans is a segmental inflammatory disease of the small- and medium-sized vessels mainly affecting the extremities. Although there are numerous reports concerning the treatment of these debilitating, chronic ulcers, such as skin grafting, local flaps, and free flaps, this report is the first published case of a patient with Buerger's disease, successfully managed with vacuum-assisted closure (VAC) application. This therapy decreases the period of hospital stay and increases patient comfort between dressings. Further clinical studies are needed to demonstrate the effectiveness and safety of VAC therapy in treatment of ulcers due to different kinds of vasculitis.
The efficacy of negative pressure wound therapy in the management of lower extremity trauma: Review of clinical evidence.
Kanakaris NK, Thanasas C, Keramaris N, Kontakis G, Granick MS, Giannoudis PV. Injury. 2007 Nov 26 [Epub ahead of print]
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A large number of aids have been conceived and introduced into clinical practice (nutritional supplements, local dressings, technical innovations) aimed at facilitating and optimising wound healing in both acute and chronic wound settings. Among these advances, negative pressure wound therapy (NPWT) has been introduced during the last 30 years, and has been analysed in over 400 manuscripts of the English, Russian and German literature. Until very recently, vacuum assisted closure (VAC((R))) (KCI, TX, USA) has been the only readily available commercial device that provides localised negative pressure to the wound and is the predominant agent used to deliver NPWT featured in this review. We conducted a comprehensive review of the existing clinical evidence of the English literature on the applications of NPWT in the acute setting of trauma and burns of the lower extremity. Overall, 16 clinical studies have been evaluated and scrutinised as to the safety and the efficacy of this adjunct therapy in the specific environment of trauma. Effectiveness was comparable to the standard dressing and wound coverage methods. The existing clinical evidence justifies its application in lower limb injuries associated with soft tissue trauma.
Comparison of Negative Pressure Wound Therapy Utilizing Vacuum-Assisted Closure to Advanced Moist Wound Therapy in the Treatment of Diabetic Foot Ulcers A Multicenter Randomized Controlled Trial.
Blume PA, Walters J, Payne W, Ayala J, Lantis J. Diabetes Care. 2007 Dec 27 [Epub ahead of print]
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Objective: To evaluate safety and clinical efficacy of Negative Pressure Wound Therapy (NPWT) compared to Advanced Moist Wound Therapy (AMWT) to treat diabetic patients with foot ulcers.
Research Design And Methods: This multicenter randomized controlled trial enrolled 342 patients mean age 58 years; 79% male. Complete ulcer closure was defined as skin closure (100% re-epithelization) without drainage or dressing requirements. Patients were randomized to either NPWT (Vacuum-Assisted Closure) or AMWT (predominately hydrogels and alginates) and received standard off-loading therapy as needed. The trial evaluated treatment until Day 112 or ulcer closure by any means. Patients whose wound achieved ulcer closure were followed at 3 and 9 months. Each study visit included closure assessment by wound exam and tracings.
Results: A greater proportion of foot ulcers achieved complete ulcer closure with NPWT (73/169, 43.2%) than AMWT (48/166, 28.9%) within the 112-day Active Treatment Phase (p=0.007). Kaplan-Meier median estimate for 100% ulcer closure was 96 days (95% CI: 75.0, 114.0) for NPWT and not determinable for AMWT (p=0.001). NPWT patients experienced significantly (p=0.035) fewer secondary amputations. The proportion of home care therapy days to total therapy days for NPWT was 9471/10579 (89.5%) and 12210/12810 (95.3%) for AMWT. In assessing safety, no significant difference between the groups was observed in treatment-related complications such as infection, cellulitis, and osteomyelitis at 6 months.
Conclusions: NPWT appears to be as safe as, and more efficacious, than AMWT for the treatment of diabetic foot ulcers. This study was registered with ClinicalTrials.gov as NCT00432965.
Press Release: Final Study Results Show V.A.C.(R) Therapy to be More Efficacious Than Advanced Moist Wound Therapy in Treating Diabetic Foot Ulcers
Results to be Published in ADA Journal "Diabetes Care"
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SAN ANTONIO Feb. 11, 2008--Kinetic Concepts, Inc. (NYSE:KCI) today announced the final efficacy results of a randomized controlled clinical trial (RCT) on the clinical efficacy of KCI's V.A.C.(R) System negative pressure wound therapy (NPWT) compared to advanced moist wound therapy (AMWT) to treat diabetic patients with foot ulcers. The study, which showed that V.A.C. Therapy is more efficacious than AMWT in the treatment of diabetic foot ulcers, will be published in the April 2008 issue of Diabetes Care, the peer-reviewed journal of the American Diabetes Association. A pre-print version of the article is currently available online at http://diabetes.org/diabetescare.
Highlights of the multi-center, RCT trial include:
-- A greater proportion of foot ulcers achieved complete ulcer
closure with V.A.C. Therapy versus AMWT;
-- Time to wound closure was less with V.A.C. Therapy than with
AMWT;
-- Patients on V.A.C. Therapy experienced significantly fewer
amputations.
"Chronic diabetic foot ulcers present a significant challenge to treating physicians," said Dr. Peter A. Blume, North American Center for Limb Preservation and principal investigator for the study. "As observed in this clinical trial, the use of V.A.C. Therapy in concurrence with debridement of the wound increased the number of diabetic foot ulcers healed, and decreased the number of amputations as compared to AMWT."
The study is the largest RCT to date comparing V.A.C. Therapy with AMWT in the treatment of this wound type. It involved 342 patients with complex, hard-to-heal diabetic foot ulcers with 90% of therapy days occurring in the home care setting. In the study, for patients on V.A.C. Therapy, complete ulcer closure was significantly greater than for those patients on AMWT (43.2% vs. 28.9%, p=0.007). Patients treated with V.A.C. Therapy healed significantly (p=0.001) faster (Kaplan-Meier median estimate time to 100% ulcer closure = 96 days) compared to AMWT (time to 100% ulcer closure not determinable). In addition, significantly fewer amputations were observed in V.A.C. Therapy patients compared to AMWT (4.1% vs. 10.2%, p=0.035). In assessing safety, the study showed that no significant difference between the groups was observed.
"This study further confirms results of a similar study of amputated diabetic foot wounds published in The Lancet on November 12, 2005," said Dr. Dan Ciaburri, KCI's Chief Medical Officer. "It also adds to KCI's significant body of clinical data that clearly shows that our V.A.C. Therapy system, including its unique foam dressing, provides clinical advantage for treatment of diabetic foot ulcers."
A method for stimulating new tissue growth is provided in which a limb is introduced into an interior portion of an outer cover. A porous component is applied to at least a portion of the limb within the outer cover. An opening through which the limb was introduced is sealed, and a negative pressure is applied to the interior portion to stimulate new tissue growth.
Here is KCI's patent on this that was only granted last week (submitted in October 2007)
Rumour has it that these two companies are (or were) in dispute over this
__________________
Craig Payne
Department of Podiatry
La Trobe University
Melbourne, Australia http://www.latrobe.edu.au/podiatry
__________________________________________________ ___________________________________ God put me on this earth to accomplish a certain number of things - right now I am so far behind, I will never die.
The views expressed above are those of the author and not that of La Trobe University This is where I am, where are you?
Negative pressure wound therapy: a vacuum of evidence?
Gregor S, Maegele M, Sauerland S, Krahn JF, Peinemann F, Lange S. Arch Surg. 2008 Feb;143(2):189-96.
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OBJECTIVE: To systematically examine the clinical effectiveness and safety of negative pressure wound therapy (NPWT) compared with conventional wound therapy. DATA
SOURCES: MEDLINE, EMBASE, CINAHL, and the Cochrane Library were searched. Manufacturers were contacted, and trial registries were screened. STUDY SELECTION: Randomized controlled trials (RCTs) and non-RCTs comparing NPWT and conventional therapy for acute or chronic wounds were included in this review. The main outcomes of interest were wound-healing variables. After screening 255 full-text articles, 17 studies remained. In addition, 19 unpublished trials were found, of which 5 had been prematurely terminated. DATA EXTRACTION: Two reviewers independently extracted data and assessed methodologic quality in a standardized manner. DATA SYNTHESIS: Seven RCTs (n = 324) and 10 non-RCTs (n = 278) met the inclusion criteria. The overall methodologic quality of the trials was poor. Significant differences in favor of NPWT for time to wound closure or incidence of wound closure were shown in 2 of 5 RCTs and 2 of 4 non-RCTs. A meta-analysis of changes in wound size that included 4 RCTs and 2 non-RCTs favored NPWT (standardized mean difference: RCTs, -0.57; non-RCTs, -1.30).
CONCLUSIONS: Although there is some indication that NPWT may improve wound healing, the body of evidence available is insufficient to clearly prove an additional clinical benefit of NPWT. The large number of prematurely terminated and unpublished trials is reason for concern.
Here is another patent just granted by US Patent Office (originally filed 2006 in Sweden):
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The present invention relates to a method at surgical operations applying negative pressure wound treatment as a post-surgical event, whereby the pressure around an organ or tissue is distributed by applying an open cell structure around the organ or tissue avoiding a move of the organ or tissue as such.
Resource utilization and economic costs of care based on a randomized trial of vacuum-assisted closure therapy in the treatment of diabetic foot wounds.
Apelqvist J, Armstrong DG, Lavery LA, Boulton AJ. Am J Surg. 2008 Mar 18 [Epub ahead of print]
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BACKGROUND: To evaluate resource utilization and direct economic costs of care for patients treated with negative-pressure wound therapy (NPWT), using the Vacuum-Assisted Closure (V.A.C.) system, compared to standard moist wound therapy (MWT).
METHODS: A total of 162 diabetic patients with post-amputation wounds (up to the trans-metatarsal level) entered a 16-week, randomized clinical trial. Patients randomized to V.A.C. (n = 77) received therapy with dressing changes every 48 hours. Control patients (n = 85) received standard MWT. Resource utilization, procedures, and direct costs were calculated and analyzed in this post hoc retrospective study.
RESULTS: There was no difference between groups for in-patient hospital stay (number of admissions or length of stay). More surgical procedures (including debridement) were required in the MWT group (120 vs 43 NPWT, P <.001). The average number of dressing changes performed per patient was 118.0 (range 12-226) for MWT versus 41 (6-140) for NPWT (P = .0001). The MWT group had 11 (range 0-106) outpatient treatment visits during the study versus 4 (range 0-47) in the NPWT group (P <.05). The average direct cost per patient treated for 8 weeks or longer (independent of clinical outcome) was $27,270 and $36,096 in the NPWT and MWT groups, respectively. The average total cost to achieve healing was $25,954 for patients treated with NPWT (n = 43) compared with $38,806 for the MWT group (n = 33).
CONCLUSION: Treatment of diabetic patients with post amputation wounds using NPWT resulted in lower resource utilization and a greater proportion of patients obtaining wound healing at a lower overall cost of care when compared to MWT.
Another patent has just been granted to test NWPT: Negative wound pressure therapy test system
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A system for testing a negative pressure wound dressing, includes a simulated wound having a housing and a wound cavity within the housing, and having a shape and dimension representative of an actual wound type, a wound dressing positionable at least over the simulated wound, a negative pressure source in fluid communication with the wound cavity, at least one sensor adapted to record at least one parameter within the simulated wound, an air leak model including a valve in fluid communication with the wound cavity whereby opening of the valve simulates an air leak within the wound cavity, a fluid source in fluid communication with the wound cavity for delivering fluid to the wound cavity to simulate presence of exudates and a computer coupled to the at least one sensor for recording and analyzing data recorded by the at least one sensor to thereby providing an indication of functioning of the system.
BACKGROUND: Treatment of diabetic foot ulcers includes a number of different regimes such as glycaemic control, re-vascularization, surgical, local wound treatment, offloading and other non-surgical treatments. Although considered the standard of care, the scientific evidence behind the various debridements used is scarce. This presentation will focus on debridement and V.A.C. Therapy, two treatments widely used in patients with diabetes and foot ulcers.
METHODS: A review of existing literature on these treatments in diabetic foot ulcers, with focus on description of the various types of debridements used, the principles behind negative pressure wound therapy (NPWT) using the V.A.C. Therapy system and level of evidence.
RESULTS: Five randomized controlled trials (RCT) of debridement were identified; three assessed the effectiveness of a hydrogel as a debridement method, one evaluated surgical debridement and one evaluated larval therapy. Pooling the three hydrogel RCTs suggested that hydrogels are significantly more effective than gauze or standard care in healing diabetic foot ulcers. Surgical debridement and larval therapy showed no significant benefit. Other debridement methods such as enzyme preparations or polysaccharide beads have not been evaluated in RCTs of people with diabetes. More than 300 articles have been published on negative pressure wound therapy, including several small RCTs and a larger multi-centre RCT of diabetic foot ulcers. Negative pressure wound therapy seems to be a safe and effective treatment for complex diabetic foot wounds, and could lead to a higher proportion of healed wounds, faster healing rates, and potentially fewer re-amputations than standard care.
CONCLUSIONS: Although debridement of the ulcer is considered a prerequisite for healing of diabetic foot ulcers, the grade of evidence is quite low. This may be due to a lack of studies rather than lack of effect. Negative pressure wound therapy seems to be safe and effective in the treatment of some diabetic foot ulcers, although there is still only one well-performed trial that evaluates the effect.
An economic evaluation of VAC therapy compared with wound dressings in the treatment of diabetic foot ulcers.
Flack S, Apelqvist J, Keith M, Trueman P, Williams D. J Wound Care. 2008 Feb;17(2):71-8.
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OBJECTIVE: To determine the cost-effectiveness ofVacuum Assisted Closure (VAC) therapy (KCI Medical), based on a comparison with both traditional and advanced wound dressings, for the treatment of diabetic foot ulcers in the US.
METHOD: A Markov model was designed to estimate the cost per amputation avoided and the cost per quality-adjusted life year (QALY) of VAC therapy, compared with both traditional and advanced dressings. Over a one-year period the Markov model simulated 1000 patients using transition probabilities obtained from the literature.The health states used in the model were: uninfected ulcer; infected ulcer; infected ulcer post-amputation; healed; healed post-amputation; amputation; and death. Patients initially treated with VAC switched to the advanced dressing after three months of treatment if their wound remained unhealed. Patients treated with traditional or advanced dressings were assumed to continue with their treatment for the full 12 months if they remained unhealed.
RESULTS: The model results demonstrate improved healing rates (61% versus 59%), more QALYs (0.54 versus 0.53) and an overall lower cost of care ($52,830 versus $61,757 per person) for patients treated with VAC therapy compared with advanced dressings.Vacuum Assisted Closure was also shown to be a dominant intervention when compared with traditional dressings.
CONCLUSION: The model results indicate thatVAC therapy is less costly and more effective than both traditional and advanced dressings.The results are robust to changes in key parameters, including the transition probabilities, the cost ofVAC therapy and the utility weights applied to health states.
A systematic review of the effectiveness of negative pressure wound therapy in the management of diabetes foot ulcers.
Noble-Bell G, Forbes A. Int Wound J. 2008 Jun;5(2):233-42.
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Foot ulcers are a common complication in patients with diabetes. Negative pressure wound therapy (NPWT) is a wound care therapy that is being increasingly used in the management of foot ulcers. This article presents a systematic review examining the effectiveness of this therapy. The review question is how effective is NPWT in achieving wound healing in diabetes foot ulcers? The primary outcome for this study was the number of patients achieving complete wound healing (secondary outcomes, other markers of wound healing, adverse events and patient satisfaction). A systematic literature review and tabulative synthesis of randomised controlled trials (RCTs). The review identified four RCTs of weak to moderate quality. Only one study examining NPWT in postamputation wound healing reported data on the primary outcome. These data show a 20% improvement in wound healing [odds ratios = 2.0%, confidence interval (CI) -1.0 to 4.0] and number needed to treat = 6 (CI 4-64). No serious treatment-related complications were reported by any of the studies. One study suggested a reduction in the risk of secondary amputation (absolute risk reduction = 7.9%, CI 0.5-15.43). Studies also reported an increase in granulation and wound-healing rates in patients treated with NPWT therapy. No data on patient satisfaction or experience were reported. While all the studies included in the review indicated that the NPWT therapy is more effective than conventional dressings, the quality of the studies were weak and the nature of the inquiries in terms of outcome and patient selection divergent. There is a strong need for larger trials to assess NPWT therapy in diabetes care with different groups of patients and in relation to different clinical objectives and parameters.
The purpose of this study is to assess the difference in the percent reduction in wound surface area, without surgery, of chronic pressure ulcers of the pelvic region for Negative Pressure Wound Therapy (NPWT) compared to standard dressing.This study is designed to provide evidence regarding NPWT as compared to standard dressing regimens and compare the efficacy, safety, effectiveness and cost-effectiveness.
INTRODUCTION: Chronic wounds come in various forms and result from a multitude of factors that play a detrimental role in the wound-healing process. A breakthrough in wound management came with the introduction of vacuum-assisted closure (VAC). Although numerous papers have been published suggesting that VAC is based upon its unique ability to accelerate the rate of granulation tissue production, enhance angiogenesis and remove excess chronic wound fluid, no attempts have been made to investigate its effect on lymph vessels.
PATIENTS AND METHODS: From April 2005 to April 2006, 80 patients with chronic wounds were treated with VAC therapy and prospectively studied. The parameters included: the length of VAC treatment, the number of dressing changes, the number of days of hospitalisation and immunocytochemical lymphatic vessel density assessments.
RESULTS: Lymph vessel proliferation was noted in all types of wounds, up to the first dressing change, but as VAC therapy continued it was apparent that patients exhibiting the same type of wounds did not exhibit the same results. Additionally, the duration of VAC therapy, dressing changes and average number of days of hospitalisation were significantly less in some cases but also prolonged in others.
CONCLUSION: VAC therapy seems to be inducing morphological and quantitative alterations on the lymph vessel network in a wound. The effect of VAC therapy varies greatly depending on the presence of underlying diseases and risk factors impairing wound healing. An increase in the density of lymph vessels manifested histologically correlates with a better clinical outcome, in terms of healing rates and hospitalisation time.
Boehringer Technologies have just been granted this patent: Tunnel dressing for use with negative pressure wound therapy system
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A tunnel dressing for use in treating a tunneling wound using negative pressure wound therapy. The tunnel dressing includes an elongate permeable member having a closed distal end for entering the wound and an open proximal end into which an applicator is removably disposed for guiding the dressing into the wound. The tunnel dressing has a support structure adapted to transport wound exudates away from the wound and to resist compression under suction. The tunnel dressing also has a wound contact surface adapted to minimize tissue entanglement to facilitate removal. The support structure and wound contact surface may be formed from the same material or from two adjacent layers of different material.
Negative pressure wound therapy
Linear Mode
