New adhesive drape for easier removal in wound therapy

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

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

• Phase: NA
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Global Biomedical Technologies, LLC (industry)
• Locations: 6 sites (Los Angeles, California and 5 other locations)
• Trial ID: NCT06717308 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are post-surgical inpatients aged 18 and older who require NPWT and can communicate their pain levels.

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.

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 performed: While similar approaches have been explored, this specific switchable adhesive technology is novel and has not been widely tested in clinical settings.

Eligibility criteria

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.

Where this trial is running

Los Angeles, California and 5 other locations

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

Study contacts

• Principal investigator: Howard S Rosing, MD, PhD — Global Biomedical Technologies, LLC
• Study coordinator: Howard S Rosing, Sponsor, MD, PhD

Conditions: Frequency and Type of Medical Adhesive-Related Skin Injury, NPWT Drape Seal Effectiveness Rate, Clinician Acceptability of New NPWT Drape, Patient Drop-out Rate From Prescribed NPWT Treatment, Pain Assessment During Medical Adhesive Drape Removal, Medical Adhesive-Related Skin Injury, pain with adhesive medical products, wound care