NCT06717308 · Global Biomedical Technologies, LLC
Evaluation of a Switchable Acrylic Adhesive Drape for Safer Removal in Negative Pressure Wound Therapy Applications.
What this study is about
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.
View original scientific description
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 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.
Interventions
DEVICE
Comfort Release® NPWT drape
Comfort Release® NPWT drape- painless and trauma-free removal, as compared to the control NPWT drape.
Primary outcome measures
Incidence of Medical Adhesive-Related Skin Injury (MARSI).
Time frame: From the first drape removal to the end of treatment- 1 to 8 weeks.
Measure: The percentage of patients experiencing Medical Adhesive-Related Skin Injury from surgical drape removal as assessed using the MARSI scale upon drape removal, and, if any abnormality is noted, a second MARSI assessment is completed. If there is a MARSI score of 1 or 2 = follow up assessment in completed in approximately 15 minutes, and a score of 3 or 4 = follow up assessment is completed in approximately 30 minutes.
Patient-reported pain scores during drape removal.
Time frame: From enrollment to the end of treatment - from 1 - 8 weeks.
Pain intensity scored on the Indiana Polyclinic Combined Pain Scale during the drape removal. Scale of 0 to10, 0 = no pain and 10= worst imaginable pain.
Change in medication use for anxiety, pain, and stress.
Time frame: From enrollment to the end of treatment - from 1 - 8 weeks.
Measure: Quantity (e.g., dosage or frequency) of medications used for anxiety, pain, and stress related to drape removal.
Drape seal integrity (leak incidence rate).
Time frame: From enrollment to the end of treatment - from 1 - 8 weeks.
Proportion of drapes maintaining an effective seal compared to or the control drape.
Patient drop-out rate from NPWT treatment due to drape issues.
Time frame: From enrollment to the end of treatment - from 1 - 8 weeks.
Measurement: Percentage of patient who discontinue NPWT treatment before completing the prescribed treatment duration drop-out from the prescribed treatment duration to determine how much pain and skin injury plays a role in patient compliance.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 18 years or older post-surgical inpatients with a plan of treatment using NPWT
- Able to communicate and consent to participation in the study
- Access to V.A.C. by KCI drape and NPWT kits
- Able to report pain level using a pain scale.
- If outpatient- able to return to the clinic for all drape/dressing changes
Exclusion criteria
- History of known hypersensitivity to acrylic adhesives
- History of known hypersensitivity to isopropyl alcohol
- 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.
- Under the age of 18 years 5. Unable to give consent, including a language barrier, unless an interpreter is readily available.
Where
- Los Angeles, California
- Torrance, California
- Miami, Florida
- Sweetwater, Florida
- New York, New York
Collaborators
National Institute for Biomedical Imaging and Bioengineering (NIBIB), Weill Medical College of Cornell University, Columbia University, Absolute Medical Center, LLC, Vital Medical Research, LLC, All South Bay Footcare, Eazy Foot & Ankle
Related conditions & keywords
Frequently asked questions
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Data: ClinicalTrials.gov · synced Jun 2, 2026 · Source of record for eligibility and locations