Home › NCT06717308

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

Surgical Drape With an Atraumatic Acrylic Adhesive for Negative Pressure Wound Therapy

Who can join

Ages 18 and older · All sexes

Inclusion Criteria:

1. 18 years or older post-surgical inpatients with a plan of treatment using NPWT
2. Able to communicate and consent to participation in the study
3. Access to V.A.C. by KCI drape and NPWT kits
4. Able to report pain level using a pain scale.
5. If outpatient- able to return to the clinic for all drape/dressing changes

Exclusion Criteria:

1. History of known hypersensitivity to acrylic adhesives
2. History of known hypersensitivity to isopropyl alcohol
3. The patient is expected to be unconscious during the drape removal/change

   -NOTE: For the Weill Cornell Medicine site only: Patient is expected to be unconscious during ALL drape removal/changes.
4. Under the age of 18 years 5. Unable to give consent, including a language barrier, unless an interpreter is readily available.

About the study

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.), or other facility standard drape, in a non-blinded randomized controlled trial.

Specific Aims Aim 1: Compare Comfort Release® drapes with V.A.C. drapes in single or short-term 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 Reduced nursing time by ≥20% Economic value through time and cost savings 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, Vital Medical Research, and All South Bay Footcare. Patients will undergo approximately three NPWT drape changes per week.

Milestones: Demonstrate statistically significant (α=0.05) improvement over V.A.C./or standard 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 at final removal, qualitative data from clinicians will be collected to assess the acceptability and usability of Comfort Release® NPWT drapes.

What is being tested

• Comfort Release® NPWT drape (device)

Sponsor: Global Biomedical Technologies, LLC · Participants: 300 · Started: Feb 10, 2025

Contact the study team

• Howard S Rosing, Sponsor, MD, PhD · Phone: 239-330-5646
• Denise L Anderson, Director of Clinical Operations & Communications, RN, WCC · Phone: 833-726-9269

Official record on ClinicalTrials.gov — NCT06717308

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.