A Prospective, Controlled, Randomised, Clinical Study of Negative Pressure Device Without Foam or Gauze for Skin and Soft Tissue Defects

Abstract

All common negative pressure wound therapy (NPWT) systems include a filler material usually foam or gauze at the wound/device interface. The filler material distributes the negative pressure evenly to all parts of the wound. The foam or gauze may fragment contributing to foreign material being retained in the wound, becoming colonised with bacteria over time, and painful dressing changes. To mitigate these, negative aspects, an impermeable embossed single-layer NPWT membrane dressing has been developed. The dressing has been coined Negative Pressure—Platform Wound Device (NP-PWD) and a foam or gauze is not required to deliver negative pressure. Rather, the pressure is permeated via the spaces between the embossed pyramids and the wrinkles in the membrane. The purpose of this study was to compare the NP-PWD to the standard of care (SOC) NPWT system in the treatment of skin and soft tissue defects. This was a prospective, randomised, controlled clinical trial. The wounds were treated with the NP-PWD or SOC NPWT system. The randomised treatment was applied for 2 days to up to 9 days after the initial application. Follow-up data were collected at each dressing change/removal and included photographs, and assessments for wound healing, infection, and adverse events. In total 24 subjects (12 NP-PWD and 12 SOC) completed the study. The NP-PWD was easy to use and fast to apply and the patients tolerated it well. The transparency of the NP-PWD allowed the provider to see the wound without removing the dressing which is an improvement over traditional NPWT. In terms of wound healing, inflammation, pain, and infection, no differences were observed between the NP-PWD and the SOC NPWT system. The NP-PWD is a simplified, single component NPWT system eliminating the use of the filler material that commonly causes challenges during treatment.