CLINICAL EVIDENCE OVERVIEW. The evidence for V.A.C. Therapy Negative Pressure Wound Therapy

CLINICAL EVIDENCE OVERVIEW The evidence for V.A.C. Therapy Negative Pressure Wound Therapy

CASE REPORTS The evidence for V.A.C. Therapy Negative Pressure Wound Therapy

Case Reports: Chronic wounds Since its introduction in the 1990s, it (V.A.C. Therapy) has unquestionably saved the limbs and lives of many patients. 1 Keith Harding, 2008. Head of the Department of Wound Healing, School of Medicine, Cardiff University. 1 A diabetic female following amputation of the left second digit and metatarsal head. 1 Day minus 60 Day minus 0 Day 11 Day 25 Day 54 Amputation of head of second metatarsal. With no improvement for one month and following complications, the patient returned to theatre for removal of non-viable tissue. V.A.C. Therapy was applied and after 11 days of treatment slough coverage had reduced to 40% of the wound surface. After 25 days of V.A.C. Therapy the wound bed showed 90% granulation tissue. At 54 days V.A.C. Therapy was discontinued as the wound bed showed 100% granulation tissue coverage. The healed foot is functional and can be accommodated within semi-bespoke footwear, the plantar tissues show no significant scarring or areas of high pressure. 2 A 64 year-old diabetic male following partial forefoot amputation. 1 Day 2 Day 10 Day 4 Post V.A.C. Conclusion 11 days after amputation and after 2 days of V.A.C. Therapy, 90% granulation tissue was obtained. After 10 days of V.A.C. Therapy the medial and lateral wound edges were seen to be advancing. After 4 days of V.A.C. Therapy the change in wound dimension was significant. The long-term goal of limb salvage was achieved. Two weeks post V.A.C. Therapy, the wound had continued to reduce in size. At four months post surgery the wound was healed. 2

Case Reports: Chronic wounds 3 A 70 year-old female patient suffering from a non-healing, combined venous/arterial leg ulcer. Day 5 Day 8 Day 5 post graft Day 29 V.A.C. Therapy initiated. Significant increase in granulation tissue formation. Wound dimensions decreasing. Evidence of graft take. Full wound closure. Following a graft, full wound closure was achieved. 4 A 22 year-old male with grade 4 pressure ulcers, formed within a year of being paralysed after a severe back injury. 1 Day 35 Sacral wound at presentation. Right hip wound at presentation. The undermined wound areas were filled with V.A.C. GranuFoam dressing. To connect both wounds the bridge technique was applied and V.A.C. Therapy initiated. Significant wound size reduction can be achieved with V.A.C. Therapy. A 50% reduction in sacral wound size was observed and the hip wound was suitably prepared for direct closure. 5 A 73 year-old man with a large sacral pressure ulcer. 1 Day 28 Day 56 Day 112 Conclusion V.A.C. Therapy started after sharp debridement and removal of black eschar. The wound bed was largely filled with granulation tissue and minimal slough. Wound dimensions decreased significantly. V.A.C. GranuFoam was replaced by V.A.C. WhiteFoam. V.A.C. GranuFoam Silver was applied. Granulation tissue was stimulated with good effect. V.A.C. Therapy managed exudate levels and protected the wound from the potential effects of faecal incontinence, promoting granulation tissue formation and epithelialisation.

Case Reports: Acute wounds 1 A 55 year-old woman with necrotising fasciitis requiring radical surgical debridement. 1 Day 24 Day 60 Day 60 Initiation of V.A.C. Therapy after radical surgical debridement of abdominal wound. V.A.C. Therapy was applied. The patient was discharged home on the V.A.C. Freedom unit after a 72% reduction in wound size. V.A.C. Therapy was discontinued. 98% successful skin graft take. Wound size had continued to decrease. V.A.C. Therapy efficiently manages large volumes of exudate and accelerates the healing time of complex wounds, resulting in reduced bed occupancy and financial savings. 2 A 66 year-old female presenting with a dehisced laparotomy wound. 1 Day minus 4 Day 5 Day 21 Day 43 Initial assessment of the wound. V.A.C. Therapy initiated. Improving wound characteristics. V.A.C. Therapy was applied on the intermittently at -125 mmhg. Patient evaluated for grafting. V.A.C. Therapy manages wound exudate in large abdominal wounds while supporting the surrounding organs and keeping the abdomen in alignment. 3 An obese 58 year-old diabetic patient following abdominal reduction surgery Day minus 9 Day 112 Day 174 Day 180 Patient presented with a dehisced wound and fistulae. 112 days after initiation of V.A.C. Therapy, the patient was discharged home. V.A.C. Therapy discontinued. Complete wound closure. Six months after the operation the scar was inconspicuous. 4

Case Reports: Trauma wounds 1 A 91 year-old female with a haematoma to the lower leg secondary to a fall. 1 At presentation Day 2 Conclusion Wound after removal of hard necrotic tissue. After complete debridement a significant undermining was revealed. The undermined area was filled with V.A.C. GranuFoam. And a second piece was used to fill the remaining cavity. After 48 hours the undermined area had decreased in size. V.A.C. Therapy was used to promote rapid growth of granulation tissue in a patient with a number of comorbidities who was at risk of delayed healing. After 8 days inpatient and 14 days care at home undermining was eliminated and granulation tissue was level with the wound margin. 2 A 76 year-old female with spreading soft tissue infection of the left lower leg. 1 At presentation Day 8 Conclusion Wound covered in necrotic tissue. Thanks to V.A.C. Therapy the patient was able to be discharged early with a positive outcome. Faster Wound bed post-larval therapy, before initiation of V.A.C. Therapy. After 8 days of treatment the patient had improved sufficiently for discharge home, where therapy was continued. Complete tissue granulation. healing, as well as odour and exudate management, are important aspects of wound care. 1 David Gray, Fiona Russell and John Timmons, 2008. Department of Tissue Viability, Grampian Health Services, Scotland. Signs of epithelisation leading to complete wounds healing. References 1. Gray, D. Russell, F. Timmons, J: Editors. VAC Therapy: An introduction and practical guide. Wounds UK, 2009. 2. KCI Times, Germany. 2008 (2) - Internal data on file. 5

V.A.C. Therapy evidence based publications Selection of V.A.C. Therapy evidence Page Reference Key finding Wound type Number Control therapy 4 Blume et al 2008 V.A.C. Therapy reduces time to healing. Diabetic Foot Ulcers 342 patients, 37 centres Advanced Moist Wound Dressings 5 Mc Nulty et al 2007 V.A.C. Therapy leads to significantly more cell proliferation. Fibroblasts grown in vitro (3-D fibrin matrix) NA Gauze under suction 6 Apelqvist et al 2008 V.A.C. Therapy reduces total treatment costs. Diabetic Foot Ulcers 162 patients Advanced Moist Wound Dressings 7 Augustin et al 2006 V.A.C. Therapy leads to a significant increase in quality of life. Acute and chronic wounds 98 centres, 176 questionaires Before and after V.A.C. Therapy Selected V.A.C. Therapy peer-reviewed publications Diabetic Foot Ulcer Armstrong DG, Lavery LA, Negative Pressure Wound Therapy after partial diabetic foot amputation; a multicentre, randomized controlled trial. Lancet 2005, 366:1704-10. Eginton MT et al. A prospective randomized evaluation of negative-pressure wound dressings for diabetic foot wounds. Annals of Vascular Surgery 2003, 17(6):645-49. McCallon SK et al. Vacuum-assisted closure versus saline moistened gauze in the healing of postoperative diabetic foot wounds. Ostomy/Wound Management 2000, 46(8):28-34. Venous Leg Ulcer Vuerstaek, JD et al. State-of-the art treatment of chronic leg ulcers: Assessing the role of Vacuum Assisted Closure (V.A.C. ) in wound healing. Journal of Vascular Surgery 2006, 44(5):1029-37. Open Abdomen Kaplan M et al. Guidelines for the Management of the Open Abdomen, Supplement to Wounds: A compendium of clinical research and practice. 2005. Wild T et al. Abdominal Dressing ein neuer Standard in der Behandlung des offenen Abdomens infolge sekundärer Peritonitis. Zentralbl Chir 2006, 131:S111-14. Pressure ulcers Ford CN et al. Interim analysis of a prospective, randomized trial of vacuum-assisted closure versus the Healthpoint system in the management of pressure ulcers. Annals of Plastic Surgery 2002, 49(1):55-61; discussion 61. Joseph E et al. A prospective, randomized trial of vacuum-assisted closure versus standard therapy of chronic nonhealing wounds. Wounds 2000, 12(3):60-67. Schwien T et al. Pressure ulcer prevalence and the role of Negative Pressure Wound Therapy in home health outcomes. Ostomy/Wound Management 2005, 51(9):47-60. Economic Mouës CM et al. An economic evaluation of the use of TNP on full-thickness wounds. Journal of Wound Care 2005, 14:224-27. Sternal Sjogren J et al. Clinical outcome after poststernotomy mediastinitis: vacuum-assisted closure versus conventional treatment. Annals of Thoracic Surgery 2005, 79:2049-55. Sjogren J et al. The impact of vacuum-assisted closure on long-term survival after post-sternotomy mediastinitis. Annals of Thoracic Surgery 2005, 80:1270-75. Trauma Page JC et al. Negative pressure wound therapy in open foot wounds with significant soft tissue defects. Ostomy/Wound Management 2005, 51:2A (Suppl). Yang CC et al. Vacuum-assisted closure for fasciotomy wounds following compartment syndrome of the leg. Journal of Surgical Orthopedic Advances 2006, 15(1):19-23. Stannard JP et al. Negative Pressure Wound Therapy to Treat Hematomas and Surgical Incisions following High-Energy Trauma. Trauma 2006, 60:1301 06. Burns and plastic surgery Moisidis E et al. A prospective, blinded, randomized, controlled clinical trial of topical negative pressure use in skin grafting. Plastic and Reconstructive Surgery 2004, 114(4):917-22. Vacuum-Assisted Closure: microdeformations of wounds and cell proliferation. Saxena V et al. Plastic and Reconstructive Surgery 2004; 114(5):1086-96 Greene AK et al. Microdeformational Wound Therapy: Effects on Angiogenesis and Matrix Metalloproteinases in Chronic Wounds of 3 Debilitated Patients. Annals of Plastic Surgery 2006, 56(4):418-22. Timmers MS et al. The effects of varying degrees of pressure delivered by negative-pressure wound therapy on skin perfusion. Annals of Plastic Surgery 2005, 55(6):665-71. Morykwas MJ et al. Vacuum-assisted closure: a new method for wound control and treatment: animal studies and basic foundation. Annals of Plastic Surgery 1997, 38:553-62. Morykwas MJ et al. Effects of varying levels of subatmospheric pressure on the rate of granulation tissue formation in experimental wounds in swine. Annals of Plastic Surgery 2001, 47:547-51. 3

V.A.C. Therapy reduces time to healing Comparison of Negative Pressure Wound Therapy using V.A.C. with advanced moist wound therapy in the treatment of diabetic foot ulcers. A Multicenter Randomised Controlled Trial. Authors: Blume P.A., Walters J., Payne W., Ayala J., Lantis J. Journal: Diabetes Care 2008, 31(4):631-36 BACKGROUND OBJECTIVES Methods Diabetic Foot Ulcers (DFU) are a significant risk factor for nontraumatic foot amputations in individuals with diabetes. To evaluate the safety and efficacy of V.A.C. Therapy compared with advanced moist wound care (AMWC) for the treatment of Diabetic Foot Ulcers (DFUs). 342 patients, 37 centers Randomisation V.A.C. Therapy (n=172) AMWC (n=169) (Predominantly hydrogels and alginates) Maximum treatment duration 112 days Follow up at 3 and 9 months RESULTS AND CONCLUSIONS V.A.C. Therapy reduces time to wound healing V.A.C. THERAPY CONTROL (ADVANCED MOIST WOUND CARE) 96 days p = 0.001 >112* days 85 90 95 100 105 110 115 Median time to complete wound closure V.A.C. Therapy: leads to greater wound area reduction leads to higher rate of wound closure shows faster wound bed preparation reduces the rate of secondary amputations 4

V.A.C. Therapy leads to 3x greater cell migration Effects of Negative Pressure Wound Therapy on fibroblast viability, chemotactic signaling, and proliferation in a provisional wound (fibrin) matrix. Authors: McNulty A.K., Schmidt M., Feeley T., Kieswetter K. Journal: Wound Repair & Regeneration 2007, 15:838-46 BACKGROUND The application of mechanical stress can metabolically activate tissues. OBJECTIVES To investigate the effects of dressing material (GranuFoam and gauze) under negative pressure with respect to: Cell morphology and viability, chemotactic signaling and cellular proliferation. Methods Fibroblasts were grown in a 3-D fibrin matrix. Cells were treated for 48 hours with V.A.C. GranuFoam Dressing or with gauze, under suction (-125 mmhg). Control treatment (static control) was without negative pressure and/or dressings. Cells were stained for viability testing and apoptosis counts. Migration and proliferation assays were performed. RESULTS AND CONCLUSIONS V.A.C. Therapy leads to significant more proliferation than gauze under suction V.A.C THERAPY GAUZE UNDER SUCTION p < 0.05 0 0.5 1 1.5 2 2.5 3 Rate of proliferation (OD 450nm) Median cell death is 2.4x greater with gauze dressings than with V.A.C. GranuFoam V.A.C. Therapy leads to 3x greater cell migration than gauze under suction 5

V.A.C. Therapy reduces total treatment costs Resource utilisation and economic costs of care based on a randomised trial of vacuum-assisted closure therapy in the treatment of diabetic foot wounds. Author: Apelqvist J., Armstrong D.G., Lavery L.A., Boulton A.J.M Journal: The American Journal of Surgery 2008, 195(6):782-88 BACKGROUND OBJECTIVES Methods Direct treatment costs for diabetic foot complications are high, exceeding $30,000. The costs for performing a single amputation are approximately $34,000, excluding the costs for increased Utilisation of inpatient services, prosthetic/rehabilitation, or home care/social services. To estimate and compare resource utilisation and direct economic costs of treatment with V.A.C. Therapy in patients with severe postoperative diabetic foot wounds. Retrospective analysis of patients enrolled in a Randomised Clinical Trial (Armstrong, Lancet 2005), using payer and societal perspectives. RCT (16-week duration) with 162 patients with partial diabetic foot amputation comparing V.A.C. Therapy and Advanced Moist Wound Care (AMWC). Patients fulfilling a minimum of 8 weeks participation in the study period were included when comparing and analysing resource utilisation and economic calculations. RESULTS AND CONCLUSIONS Lower average total cost of treatment for V.A.C. Therapy V.A.C THERAPY ADVANCED MOIST WOUND CARE $ 25,954 $ 38,806 0 5000 10000 15000 20000 25000 30000 35000 40000 Cost difference: $12,852 Average total cost to achieve 100% healing ($) A higher proportion of wounds treated with V.A.C. Therapy healed compared to AMWC (55.8% vs 38.8%, p=0.040). 89.1% of patients were treated in a homecare setting after acute care intervention. V.A.C. Therapy is a cost-effective intervention for patients with complex post-operative wounds. 6 Treatment with V.A.C. Therapy resulted in a greater proportion of patients obtaining wound healing at a lower overall cost of care when compared to AMWC.

V.A.C. Therapy leads to a significant increase in quality of life Evaluation of patient benefits of ambulatory and stationary use of V.A.C. Therapy Author: Augustin M., Zschocke I. Journal: MMW-Fortschritte der Medizin Originalien 2006, 1(148):S25 32 BACKGROUND OBJECTIVES Methods Currently no evaluation from a patient perspective exists for V.A.C. Therapy. To evaluate how patients experience the use of V.A.C. Therapy in acute and chronic wounds. Secondly to investigate how patients manage the ambulatory and stationary use of V.A.C. Therapy. Prospective, open, non-controlled multicentre (n=98) evaluation of 176 questionaires. Questionnaire at the latest treatment before the start of V.A.C. Therapy and at the end of V.A.C. Therapy. Use of a short version of the validated questionnaire (FLQA-wk; Freiburg Life Quality Assessment) and a patient-defined questionnaire. The FLQA questionnaire is specifically developed to measure quality of life for patients with wounds. Questionnaire consisted of physician and patient specific sections. Specific evaluation on the handling of V.A.C. Therapy. Data collected on the wound status (epithelialization, granulation, fibrin formation and necrosis). RESULTS AND CONCLUSIONS V.A.C. Therapy significantly improves patient quality of life A questionnaire comparison study in which 98 centres compared data before and after V.A.C. Therapy. Physical complaints *** **p<0.01 ***p<0.001 Everyday life complaints *** Social life complaints *** Psychological complaints *** Therapy burden *** Complaints with satisfaction ** Overall complaints *** PRIOR TO V.A.C THERAPY AFTER V.A.C THERAPY 1 2 3 4 5 1 = no impact 5 = high impact 7

3,000,000patients treated The clinical evidence for V.A.C. Therapy The efficacy of V.A.C. Therapy is underpinned by established mechanisms of action at cellular (Microstrain) and tissue (Macrostrain) levels, clinical research and economic studies. To date over: 450 peer-reviewed articles 60 textbook citations 460abstracts 16 RCTs United Kingdom KCI Medical Ltd KCI House Langford Business Park Langford Locks Kidlington OX5 1GF United Kingdom 24h Customer Support KCI Advantage Centre Tel +44 (0) 800 980 8880 Fax +44 (0)1865 840 626 www.kci-medical.com kci international head office KCI Europe Holding B.V. Parktoren, 6th Floor Van Heuven Goedhartlaan 11 PO Box 129 1180 AC Amstelveen The Netherlands Tel +31 (0) 20 426 0000 Fax +31 (0) 20 426 0099 www.kci-medical.com GLOBAL HEAD OFFICE KCI International 8023 Vantage Drive San Antonio TX 78230 U.S.A. T(free) 1 800 531 5396, extension 6335 Tel +1 210 255 6335 Fax +1 210 255 6991 www.kci-medical.com 2009 KCI Licensing, Inc. All Rights Reserved. All trademarks designated herein are property of KCI Licensing, Inc, its affiliates and licensors. Those KCI trademarks designated with the symbol are registered and those designated with TM are considered to be proprietary trademarks or are pending trademark applications in at least one country where this product/ work is commercialized. Most KCI products referred to herein are subject to patents or patent applications. KCI Product code KCII 1083-01-09-En