NCT06717308

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

Recruiting now NA Last updated 4 December 2025

What this trial tests

NA trial testing Comfort Release® NPWT drape in Frequency and Type of Medical Adhesive-Related Skin Injury in 300 participants. Currently enrolling.

Timeline

10 February 2025

Primary endpoint
31 August 2026

15 September 2026

Quick facts

Lead sponsor	Global Biomedical Technologies, LLC
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	300
Start date	10 February 2025
Primary completion	31 August 2026
Estimated completion	15 September 2026
Sites	4 locations across United States

Drugs / interventions tested

• Comfort Release® NPWT drape

Conditions studied

• Frequency and Type of Medical Adhesive-Related Skin Injury — all drugs for Frequency and Type of Medical Adhesive-Related Skin Injury →
• NPWT Drape Seal Effectiveness Rate (or Leak Incidence Rate) — all drugs for NPWT Drape Seal Effectiveness Rate (or Leak Incidence Rate) →
• Clinician Acceptability of New NPWT Drape — all drugs for Clinician Acceptability of New NPWT Drape →
• Patient Drop-out Rate From Prescribed NPWT Treatment — all drugs for Patient Drop-out Rate From Prescribed NPWT Treatment →

Sponsor

Global Biomedical Technologies, LLC

Who can join

18 and older, any sex, with Frequency and Type of Medical Adhesive-Related Skin Injury or NPWT Drape Seal Effectiveness Rate (or Leak Incidence Rate). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 nursing time by ≥20% Economic value through time and cost savings

At each dressing change and final removal, qualitative data from clinicians will assess the acceptability and usability of Comfort Release® NPWT drapes.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.