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NCT06717308 · ClinicalTrials.gov registry record · NA
Evaluation of a Switchable Acrylic Adhesive Drape for Safer Removal in Negative Pressure Wound Therapy Applications.
A NA study of Frequency and Type of Medical Adhesive-Related Skin Injury and NPWT Drape Seal Effectiveness Rate (or Leak Incidence Rate), sponsored by Global Biomedical Technologies.
- Recruiting
- Registry status
- NA
- Development phase
- 300
- Enrollment target
- 4
- Study locations
NCT06717308 is a NA study of Frequency and Type of Medical Adhesive-Related Skin Injury and NPWT Drape Seal Effectiveness Rate (or Leak Incidence Rate) that is actively recruiting participants, run by Global Biomedical Technologies. The registered enrollment target is 300 participants. The trial reports 4 study locations across 2 states.
The verdict
NCT06717308, a NA study of Frequency and Type of Medical Adhesive-Related Skin Injury and NPWT Drape Seal Effectiveness Rate (or Leak Incidence Rate), is actively recruiting participants, sponsored by Global Biomedical Technologies.
- RECRUITING
- Registry status
- NA
- Development phase
- 300 participants
- Enrollment target
- 4
- Study locations
Study 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.) 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 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 and Vital Medical Research. Patients will undergo three NPWT drape changes per week. Milestones: Demonstrate statistically significant (α=0.05) improvement over V.A.C. 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
Conditions Studied
Interventions
- DEVICE Comfort Release® NPWT drape
Study Locations (4)
Florida
- Absolute Medical Center, LLC - Miami
- Vital Medical Research - Sweetwater
New York
- Columbia University Medical Center - New York
- Weill Cornell Medical Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2025-02-10 |
| Est. Completion | 2026-09-15 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06717308
The ClinicalTrials.gov registry entry for NCT06717308 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Global Biomedical Technologies, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Frequency and Type of Medical Adhesive-Related Skin Injury appearing as the primary indexed condition, and to 1 intervention - of which Comfort Release® NPWT drape is the first listed.
NCT06717308 reports 4 study locations spanning 2 distinct geographic areas - top geographies include Florida, New York.
Frequently Asked Questions
What is clinical trial NCT06717308 about?
NCT06717308 is a clinical study titled "Evaluation of a Switchable Acrylic Adhesive Drape for Safer Removal in Negative Pressure Wound Therapy Applications.". 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...
What is the current status of trial NCT06717308?
This trial is currently recruiting. It is a NA study. The enrollment target is 300 participants. The study started on 2025-02-10. Estimated completion is 2026-09-15.
What conditions does trial NCT06717308 study?
This clinical trial studies the following 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.
What interventions are being tested in trial NCT06717308?
The interventions under investigation include: Comfort Release® NPWT drape (DEVICE).
Who is sponsoring clinical trial NCT06717308?
This trial is sponsored by Global Biomedical Technologies, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06717308 being conducted?
This trial has 4 study locations across Florida, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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