New adhesive drape for easier removal in wound therapy
Official title: Surgical Drape With an Atraumatic Acrylic Adhesive for Negative Pressure Wound Therapy
Run by Global Biomedical Technologies, LLC · NCT06717308 · Data updated 2026-11-12
This study tests a new type of adhesive drape for wound therapy to see if it makes removal easier and more comfortable for patients after surgery compared to the standard drape.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Global Biomedical Technologies, LLC Industry-sponsored |
| Locations | 7 sites (Los Angeles, California and 6 other locations) |
| Status | Recruiting |
| Started | February 10, 2025 |
| Main results expected | February 28, 2027 |
| Study ends | March 31, 2027 |
| Registry record updated | October 29, 2026 |
| Trial ID | NCT06717308 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are post-surgical inpatients aged 18 and older who require NPWT and can communicate their pain levels.
✕Probably not a fit
Patients with known hypersensitivity to acrylic adhesives or isopropyl alcohol, or those who have had NPWT treatment in the past three months, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates a novel NPWT drape featuring 'switchable adhesive' technology designed to enhance patient comfort during removal while maintaining an effective seal. The Comfort Release® drape will be compared to the standard V.A.C. drape in post-surgical patients to assess skin irritation, pain levels, and clinician usability. The study aims to provide clinical validation for FDA clearance and improve outcomes related to medical adhesive-related skin injuries (MARSI). Participants will be monitored for pain assessment and overall satisfaction with the drape's performance.
Why it matters
Potential benefit: If successful, this innovation could significantly reduce pain and skin injuries associated with adhesive removal in wound therapy.
How similar studies have gone: While similar approaches have been explored, this specific switchable adhesive technology is novel and has not been widely tested in clinical settings.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 18 years or older post-surgical or chronic wound patients, inpatients or outpatients, 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 due to a language barrier, unless an interpreter is readily available.
Where it's running
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Eazy Foot & Ankle
Los Angeles, California, United States Recruiting -
All South Bay Footcare/Podiatry Group, Inc.
Torrance, California, United States Recruiting -
Absolute Medical Center, LLC
Miami, Florida, United States Recruiting -
Weill Cornell Medical Center
New York, New York, United States Recruiting -
Vital Medical Research
Sweetwater, Florida, United States Terminated -
Columbia University Medical Center
New York, New York, United States Completed
Show 1 more location
-
Cutting Edge Research LLC
Circleville, Ohio, United States Not yet recruiting
Study contacts
- Principal investigator: Howard S Rosing, MD, PhD — Global Biomedical Technologies, LLC
- Study coordinator: Howard S Rosing, Sponsor, MD, PhD
- Email: hrosing@comfortrelease.com
- Phone: 239-330-5646
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.