NCT06717308RecruitingNot Applicable

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

Global Biomedical Technologies, LLC9 sites in 1 country300 target enrollmentStarted: February 10, 2025Last updated: August 12, 2026

Conditions

Interventions

Trial Snapshot

Phase: Not Applicable
Status: Recruiting
Sponsor
Enrollment: 300
Locations: 9
Primary Endpoint: Incidence of Medical Adhesive-Related Skin Injury (MARSI).

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

Brief 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.), 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.

Detailed Description

Study Overview: Two-Aimed NPWT Drape Clinical Trial

Global Biomedical Technologies is advancing a novel surgical drape for negative pressure wound therapy (NPWT) that leverages Comfort Release®-a "switchable adhesive" technology designed for painless and trauma-free removal. This innovative adhesive incorporates oligo(glycerol sebacate) (OGS) and polyacrylate, allowing strong bonding during use and rapid release upon exposure to isopropyl alcohol (IPA). This product addresses the unmet need for effective NPWT adhesives that prevent medical adhesive-related skin injuries (MARSI) without compromising performance.

Key Features of Comfort Release® Adhesive:

Composition: OGS, a biodegradable elastomer pre-polymer, forms hydrogen bonds with IPA, enabling adhesive release.
Performance: A >70% drop in adhesive strength within 5 seconds of 70% IPA application.
Benefits: Reduces pain and trauma at removal, maintains effective NPWT seals, and improves patient outcomes.

This Direct-to-Phase II study compares the Comfort Release® NPWT drape with the market leader, V.A.C. drape (KCI Technologies, Inc.), or standard drape, focusing on clinical performance, patient outcomes, and clinician feedback.

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel
Primary Purpose: Treatment
Masking: None

Eligibility Criteria

Ages: 18 Years to — (Adult, Older Adult)
Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

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

Exclusion Criteria

•History of known hypersensitivity to acrylic adhesives
•History of known hypersensitivity to isopropyl alcohol
•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.
•Under the age of 18 years
•Unable to give consent, including a language barrier, unless an interpreter is readily available.

Arms & Interventions

Multi-use chronic wound NPWT drape application

Active Comparator

Aim 2: A comparison of the performance of Comfort Release® drapes with V.A.C. drapes in serial-use NPWT applications in a randomized controlled trial. Chronic wound patients (n=100) with prescribed NPWT will be enrolled at Weill Cornell Medical Center under Principal Investigator Dr. Robert Winchell, Vital Medical Research under Deeza Frankel, DPM, and All South Bay Footcare under Albert A. Elhiani, DPM. All patients will undergo 3 NPWT drape changes per week. Patients will be randomized to control (V.A.C. or standard drape) or intervention (Comfort Release® drape) for the duration of their study enrollment. All other components of the NPWT device, including but not limited to the pump, tubing, foam, or dressing insert, will be identical.

Randomize patients- 1/2 of the patients to receive KCI or standard drape, and 1/2 to receive the intervention- Comfort Release drape. The intervention is a change in a component of the NPWT treatment kit.

Intervention: Comfort Release® NPWT drape (Device)

Single or short-term use post-surgical NPWT drape application

Active Comparator

Aim 1 description: A comparison of the performance of Comfort Release® drapes with V.A.C. drapes in single-use NPWT applications in a randomized controlled trial. Post-surgical patients (n=200) with a prescribed treatment of Negative Pressure Wound Therapy (NPWT) will be enrolled at Columbia Presbyterian Hospital under co-Principal Investigator Dr. Jarrod Bogue, and Absolute Medical Center under PI: Daniel Careage, MD, for single-use NPWT. Patients will be randomized to a single-use control (V.A.C. drape) or intervention (Comfort Release® drape). All other components of the NPWT device, including but not limited to the pump, tubing, foam, or dressing insert, will be identical. Randomize patients- 1/2 of the patients to receive the KCI drape and 1/2 to receive the intervention - Comfort Release drape. The intervention is a change in a component in the NPWT treatment kit.

Intervention: Comfort Release® NPWT drape (Device)

Outcomes

Primary Outcomes

Incidence of Medical Adhesive-Related Skin Injury (MARSI).

Time Frame: From the first drape removal to the end of treatment- 1 to 8 weeks.

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.

Patient-reported pain scores during drape removal.