Evaluation of a Switchable Acrylic Adhesive Drape for Safer Removal in Negative Pressure Wound Therapy Applications.

Study Summary

Negative pressure wound therapy (NPWT) is widely used for chronic and acute wounds, severe burns, and post-operative care. Despite its benefits, the strong adhesive required to maintain an airtight seal increases the risk of medical adhesive-related skin injuries (MARSI), pain, and discomfort during removal. Global Biomedical Technologies (GBT) aims to develop an NPWT drape with "switchable adhesive" technology to enhance removal while maintaining an effective seal. This innovation is expected to benefit both single-use and serial-use NPWT applications by reducing MARSI and improving patient comfort. This project will compare the functionality and acceptability of Comfort Release® NPWT drapes with the industry-standard V.A.C. drape (KCI Technologies, Inc.) in a non-blinded randomized controlled trial. Specific Aims Aim 1: Compare Comfort Release® drapes with V.A.C. drapes in single-use NPWT applications in post-surgical patients (n=200) at Columbia University Medical Center, Weill Cornell Medical Center, and Absolute Medical Center. Milestones: Demonstrate statistically significant (α=0.05) improvement over V.A.C. drapes in: Reduction of MARSI (Medical Adhesive-Related Skin Injury scoring system) Decreased pain (Indiana Polyclinic Combined Pain Scale) Reduced need for pain/anxiety medication Equivalent or improved seal effectiveness (leak incidence rate) Clinician acceptability Aim 2: Compare Comfort Release® drapes with V.A.C. drapes in serial-use NPWT applications in chronic wound patients (n=100) at Weill Cornell Medical Center and Vital Medical Research. Patients will undergo three NPWT drape changes per week. Milestones: Demonstrate statistically significant (α=0.05) improvement over V.A.C. drapes in: Reduction of MARSI Decreased pain (Indiana Polyclinic Combined Pain Scale) Improved compliance with treatment duration Reduced need for pain/anxiety medication Equivalent or better seal effectiveness Clinician acceptability (questionnaire score \>4) Reduced

Primary Outcome

Measure: The percentage of patients experiencing Medical Adhesive-Related Skin Injury from surgical drape removal as assessed using the MARSI scale upon drape removal, and, if any abnormality is noted, a second MARSI assessment is completed. If there is a MARSI score of 1 or 2 = follow up assessment in completed in approximately 15 minutes, and a score of 3 or 4 = follow up assessment is completed in approximately 30 minutes.

Conditions Studied

Interventions

• DEVICE Comfort Release® NPWT drape

Study Locations (4)