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Evaluation of a Switchable Acrylic Adhesive Drape for Safer Removal in Negative Pressure Wound Therapy Applications.

RecruitingNAAges 18 Years - anyAllGlobal Biomedical Technologies, LLC
NCT06717308 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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® drap

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📋 Eligibility rules (as published)
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.
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What it tests

  • Comfort Release® NPWT drape
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Where

7 sites
Eazy Foot & Ankle
Los Angeles, United States
All South Bay Footcare/Podiatry Group, Inc.
Torrance, United States
Absolute Medical Center, LLC
Miami, United States
Vital Medical Research
Sweetwater, United States
Columbia University Medical Center
New York, United States
Weill Cornell Medical Center
New York, United States
Cutting Edge Research LLC
Circleville, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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