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
Presenter Classification
Faculty
Presentation Type
Podium or Poster Presentation
Publication Date
4-24-2025
Start Date
24-4-2025 11:40 AM
End Date
24-4-2025 12:00 PM
Keywords
Incisional Negative Pressure Wound Therapy, Skin Irritation, Patient Comfort, Patient Tolerance, Medical Adhesive Related Skin Injury
Abstract Type
Research
Abstract
Purpose and Aim
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. 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
This quantitative study was approved by IRB at Lincoln Memorial University. Sixteen healthy volunteers aged meeting inclusion and exclusion criteria participated in the study. Participants acted as their own control, with researchers randomizing the experimental condition to a specific knee. Researchers prepped each knee, 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 for one week unless an unexpected event resulted in discontinuation of a device.
At dressing removal, knees were swabbed, photographed, and a blinded clinician performed a skin assessment using an FDA-defined scale. The Wilcoxon Rank Sum test was used to compare outcomes between groups.
Results
No significant difference existed in dressing survivability and skin infection risk. However, study results demonstrate improved patient comfort and tolerance for the new iNPWT system and lower skin irritation scores than the control system.
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
Purpose and Aim
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. 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
This quantitative study was approved by IRB at Lincoln Memorial University. Sixteen healthy volunteers aged meeting inclusion and exclusion criteria participated in the study. Participants acted as their own control, with researchers randomizing the experimental condition to a specific knee. Researchers prepped each knee, 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 for one week unless an unexpected event resulted in discontinuation of a device.
At dressing removal, knees were swabbed, photographed, and a blinded clinician performed a skin assessment using an FDA-defined scale. The Wilcoxon Rank Sum test was used to compare outcomes between groups.
Results
No significant difference existed in dressing survivability and skin infection risk. However, study results demonstrate improved patient comfort and tolerance for the new iNPWT system and lower skin irritation scores than the control system.