Recruiting

Acrylic Adhesive Drape

Sponsor:

Global Biomedical Technologies, LLC

Code:

NCT06717308

Conditions

Frequency and Type of Medical Adhesive-Related Skin Injury

NPWT Drape Seal Effectiveness Rate (or Leak Incidence Rate)

Clinician Acceptability of New NPWT Drape

Patient Drop-out Rate From Prescribed NPWT Treatment

Pain Assessment During Medical Adhesive Drape Removal

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Comfort Release® NPWT drape

Study Details

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.

Conditions

Frequency and Type of Medical Adhesive-Related Skin Injury

NPWT Drape Seal Effectiveness Rate (or Leak Incidence Rate)

Clinician Acceptability of New NPWT Drape

Patient Drop-out Rate From Prescribed NPWT Treatment

Pain Assessment During Medical Adhesive Drape Removal

Study ID

NCT06717308

Start date

Feb 10, 2025

Status verified date

Aug, 2026

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Feb 28, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Single or short-term use post-surgical NPWT drape application

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.

active comparator: Multi-use chronic wound NPWT drape application

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.

Interventions

Comfort Release® NPWT drape

Comfort Release® NPWT drape- painless and trauma-free removal, as compared to the control NPWT drape.

Primary outcome measure

  • Incidence of Medical Adhesive-Related Skin Injury (MARSI). [ Time Frame: From the first drape removal to the end of treatment- 1 to 8 weeks. ]
  • Patient-reported pain scores during drape removal. [ Time Frame: From enrollment to the end of treatment - from 1 - 8 weeks. ]
  • Change in medication use for anxiety, pain, and stress. [ Time Frame: From enrollment to the end of treatment - from 1 - 8 weeks. ]
  • Drape seal integrity (leak incidence rate). [ Time Frame: From enrollment to the end of treatment - from 1 - 8 weeks. ]
  • Patient drop-out rate from NPWT treatment due to drape issues. [ Time Frame: From enrollment to the end of treatment - from 1 - 8 weeks. ]

Central Contacts and Locations

Central contacts

Howard S Rosing, Sponsor, MD, PhD

239-330-5646hrosing@comfortrelease.com

Denise L Anderson, Director of Clinical Operations & Communications, RN, WCC

833-726-9269danderson@comfortrelease.com

Locations

Eazy Foot & Ankle

Recruiting

Los Angeles, California, United States, 90035

Contacts

Rosie Berrios, Office Manager

310-326-0202allsouthbayfootcare@gmail.com

Jazmine, Receptionist

424-279-9332info@eazyfoot.com

Principal Investigator:

Albert A Elhiani, DPM

All South Bay Footcare/Podiatry Group, Inc.

Recruiting

Torrance, California, United States, 90505

Contacts

Rosie Berrios, Office Manager

310-326-0202allsouthbayfootcare@gmail.com

Jazmine, Receptionist

424-279-9332info@eazyfoot.com

Principal Investigator:

Albert A Elhiani, DPM

Weill Cornell Medical Center

Recruiting

New York, New York, United States, 10065

Contacts

Amy Chun

chh4020@med.cornell.edu

Principal Investigator:

Robert J Winchell, MD

More Information

Sponsor

Global Biomedical Technologies, LLC

Last update posted

Aug 12, 2026

Last verified

Aug, 2026

Keywords

  • Medical Adhesive-Related Skin Injury (MARSI)
  • pain with adhesive medical products
  • wound care
  • NPWT drape
  • Negative Pressure Wound Therapy
  • Surgical Drapes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Global Biomedical Technologies, LLC on 2026-08-12.