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

Launched by GLOBAL BIOMEDICAL TECHNOLOGIES, LLC · Dec 3, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new type of medical adhesive drape designed for negative pressure wound therapy (NPWT), which is a treatment used for healing various types of wounds, especially those that are difficult to heal. The main goal is to see if the new drape, called Comfort Release®, can reduce skin injuries and pain during removal compared to the current standard drape. Researchers will enroll up to 300 participants, including post-surgical patients and those with chronic wounds, who are 18 years or older and can communicate their experiences.

Participants in the trial can expect to use either the Comfort Release® drape or the standard drape during their treatment. They will provide feedback on their pain levels and any skin irritation they experience. The study aims to find out if the new drape makes it easier and less painful to remove while still being effective in keeping wounds sealed. If you or a loved one are considering participation, it's important to know that individuals with specific allergies to adhesives or who have had recent NPWT treatment may not be eligible.

Gender

ALL

Eligibility criteria

• 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.
• Exclusion Criteria:
• • 1. History of known hypersensitivity to acrylic adhesives
• • 2. History of known hypersensitivity to isopropyl alcohol
• • 3. NPWT treatment within past 3 months
• • 4. The patient is expected to be unconscious during the drape removal/change
• • 5. Under the age of 18 years 6. Unable to give consent, including language barrier, unless an interpreter is readily available.