Evaluation of a Switchable Acrylic Adhesive Drape for Safer Removal in Negative Pressure Wound Therapy Applications.
Public ClinicalTrials.gov record NCT06717308. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Official title
Surgical Drape With an Atraumatic Acrylic Adhesive for Negative Pressure Wound Therapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06717308
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 300 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 9, 2025
- Primary completion
- Feb 27, 2027
- Completion
- Mar 30, 2027
- Last update posted
- Aug 11, 2026
2025 – 2027
United States locations
- U.S. sites
- 6
- U.S. states
- 3
- U.S. cities
- 5
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Eazy Foot & Ankle | Los Angeles | California | 90035 | Recruiting |
| All South Bay Footcare/Podiatry Group, Inc. | Torrance | California | 90505 | Recruiting |
| Absolute Medical Center, LLC | Miami | Florida | 33126 | Active, not recruiting |
| Vital Medical Research | Sweetwater | Florida | 33174 | Terminated |
| Columbia University Medical Center | New York | New York | 10032 | Completed |
| Weill Cornell Medical Center | New York | New York | 10065 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06717308, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 11, 2026 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06717308 live on ClinicalTrials.gov.