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

Recruiting now · Not applicable

Conditions studied: 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

In brief

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-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.

Key facts

Study ID: NCT06717308
Run by: Global Biomedical Technologies, LLC
People needed: 300
Starts: 2025-02-10
Expected to finish: 2026-09-15
Last updated by the study team: 2026-06-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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 5. Unable to give consent, including a language barrier, unless an interpreter is readily available.

Where it is running

Absolute Medical Center, LLC — Miami, Florida, United States (enrolling)
Vital Medical Research — Sweetwater, Florida, United States (enrolling)
Weill Cornell Medical Center — New York, New York, United States (enrolling)
Eazy Foot & Ankle — Los Angeles, California, United States
All South Bay Footcare/Podiatry Group, Inc. — Torrance, California, United States
Columbia University Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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