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Clinical Assessment of the Efficacy of a Single-Use Negative Pressure Wound Therapy System, Compared to Traditional Negative Pressure Wound Therapy in the Treatment of Venous Leg Ulcers and Diabetic Foot Ulcers: A Randomized Controlled Trial

Other presenters

Cyaandi Dove, DPM
Alex Reyzelman, DPM
Dean Vayser, DPM, FACFAS
Henry Jaimes, MD, PhD

Poster location

At least 70% of leg ulcers are the result of chronic venous insufficiency1

Diabetic foot ulcers (DFUs) affect 15 – 25% of all diabetic subjects during their lifetime1,3,4 and precede 84% of all lower leg amputations.5 For DFUs that fail to improve (>50% wound area reduction) after four weeks of standard wound therapy it is recommended to consider the use of adjunctive wound therapy options, including Negative Pressure Wound Therapy (NPWT)6

Equivalent clinical outcomes have been noted in comparative studies of traditional Negative Pressure Wound Management (tNPWT) systems.7,8 tNPWT may be complicated to apply and use, and the size of the pump and the canister may be intrusive and limit patient mobility2,8,9

Single Use Negative Pressure Wound Therapy (sNPWT) systems are based on the same principles of action as tNPWT systems, but are smaller and disposable.8 Therefore, for approved indications, sNPWT systems are expected to simplify the application and management of NPWT, at the same time making the therapy accessible to more patients, including active and homebound individuals10

1. Singer A, Tassiopoulos A, Kirsner R, Evaluation and Management of Lower-Extremity Ulcers, N Engl J Med, 2017; 377: 1559-67.
2. Vig S, Dowsett C, Berg L, et al, International expert panel on negative pressure wound therapy. Evidence-based recommendations for the use of negative pressure wound therapy in chronic wounds: steps towards an international consensus, J Tissue Viability, 2011; 20 Suppl 1: S1-S18.
3. Andrews KL, Houdek MT, Kiemele LJ, Wound management of chronic diabetic foot ulcers: from the basics to regenerative medicine, Prosthet Orthot Int, 2015; 39(1): 29-39.
4. Markakis K, Bowling FL, Boulton AJ, The diabetic foot in 2015: an overview. Diabetes Metab Res Rev, 2016; 32 Suppl 1:169-78.
5. Brem H, Tomic-Canic M, Cellular and molecular basis of wound healing in diabetes, J Clin Invest, 2007; 117(5):1219-22.
6. Hingorani A, LaMuraglia GM, Henke P, et al. The management of diabetic foot: A clinical practice guideline by the Society for Vascular Surgery in collaboration with the American Podiatric Medical Association and the Society for Vascular Medicine. J Vasc Surg, 2016; 63(2 Suppl):3S-21S.
7. Rahmanian-Schwarz A, Wilkomm L, Gonser P, Hirt B and Schaller H, A novel option in negative pressure wound therapy (NPWT) for chronic and acute wound care, Burns, 2012; 38(4): 573-577.
8. Hurd T, Trueman P, Rossington A, Use of a portable, single use negative pressure wound therapy device in home care patients with low to moderately exuding wounds: A case series, Ostomy Wound Management, 2014; 60(3): 30-36.
9. Birke-Sorensen H, Malmsjo M, Rome P, et al, International expert panel on negative pressure wound therapy. Evidence based recommendations for negative pressure wound therapy: treatment variables (pressure levels, wound filler and contact layer)-steps towards an international consensus, J Plast Reconstr Aesthet Surg, 2011; 64 Suppl: S1-S16.
10. Delhougne G, Hogan C, Tarka K, Nair S, A retrospective, cost-minimization analysis of disposable and traditional negative pressure wound therapy Medicare paid claims, Ostomy Wound Management, 2018; 64(1): 26-33 doi:10.25270/owm.2017.6.
11. Malmsjö M, Lindstedt S, Ingemansson R. Biological eff ects of a disposable, canisterless Negative Pressure Wound Therapy system. (2014) Eplasty, 14: e15