Evaluation of a new incisional dressing and disposable negative pressure device compared to the market-leading system for dressing survivability, user comfort, and skin cleanliness: A randomized trial in healthy volunteers

Introduction: Incisional negative pressure wound therapy (iNPWT) reduces the risk of surgical site infections and other wound complications. However, skin irritation can occur from the application of iNPWT.1,2 A new incisional dressing aims to minimize the risk of skin irritation when used with iNPWT. This study compares the new incisional dressing with a new disposable NPWT device (experimental condition) to the market-leading iNPWT system (control condition) for dressing survivability, pain/discomfort, nuisance, skin irritation, and skin bioburden levels at seven days.Methods:Sixteen healthy volunteers aged 40–80 with healthy skin and no history of knee pain, skin sensitivity, or allergies to dressing components, chlorhexidine, or isopropyl alcohol participated in the study (NCT05559697). Participants acted as their own control, with researchers randomizing the experimental condition to a specific knee.  Researchers prepped each knee as if for surgery, placed each dressing, and started the NPWT device according to manufacturer instructions. Participants rated discomfort and nuisance using a 100 mm VAS scale and assessed dressing damage daily. Participants continued with each device for seven days unless there was patient discomfort, an adverse skin reaction, and/or pressure could not be maintained. At dressing removal, intact dressings were removed aseptically, knees were swabbed and photographed, and a blinded clinician performed a skin assessment using an FDA-defined scale.3 The Wilcoxon Rank Sum test was used to compare outcomes between the experimental and control devices.Results:No significant difference existed in dressing survivability with 11 experimental and six control dressings lasting seven days. Each surviving dressing maintained a clean environment with no growth of bacteria from knee swabs. Participants indicated improved discomfort (-21mm [-37.5 - -3.00], p=0.0042) and nuisance (-38.3 [-54.00 - -19.00]) for the experimental condition than the control condition at removal. Knees exposed to the experimental condition exhibited lower skin irritation scores than the control condition(-3.00 [-5 - -1], p=0.0035).Discussion: Study results demonstrate improved patient comfort and tolerance for the new iNPWT system and lower skin irritation scores than the control system.References:1. Groenen et al. (2023) eClinicalMedicine. https://doi.org/10.1016/j.eclinm.2023.102105 2. James et al. (2024) Am J Surg. https://doi.org/10.1016/j.amjsurg.2023.10.031 3. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm