Condition: Frequency and Type of Medical Adhesive-Related Skin Injury · NPWT Drape Seal Effectiveness Rate (or Leak Incidence Rate) · Clinician Acceptability of New NPWT Drape · Sponsor: Global Biomedical Technologies, LLC
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…
This description comes directly from the study's public registry record.
Howard S Rosing, Sponsor, MD, PhD · 239-330-5646 · hrosing@comfortrelease.com
Denise L Anderson, Director of Clinical Operations & Communications, RN, WCC · 833-726-9269 · danderson@comfortrelease.com
Always discuss trial participation with your own doctor first.
| 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 |
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Source record: clinicaltrials.gov/study/NCT06717308