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 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.

Study Overview: Two-Aimed NPWT Drape Clinical Trial Global Biomedical Technologies is advancing a novel surgical drape for negative pressure wound therapy (NPWT) that leverages Comfort Release®-a "switchable adhesive" technology designed for painless and trauma-free removal. This innovative adhesive incorporates oligo(glycerol sebacate) (OGS) and polyacrylate, allowing strong bonding during use and rapid release upon exposure to isopropyl alcohol (IPA). This product addresses the unmet need for effective NPWT adhesives that prevent medical adhesive-related skin injuries (MARSI) without compromising performance. Key Features of Comfort Release® Adhesive: * Composition: OGS, a biodegradable elastomer pre-polymer, forms hydrogen bonds with IPA, enabling adhesive release. * Performance: A \>70% drop in adhesive strength within 5 seconds of 70% IPA application. * Benefits: Reduces pain and trauma at removal, maintains effective NPWT seals, and improves patient outcomes. This Direct-to-Phase II study compares the Comfort Release® NPWT drape with the market leader, V.A.C. drape (KCI Technologies, Inc.), or standard drape, focusing on clinical performance, patient outcomes, and clinician feedback. Study Objectives: 1. Evaluate Performance: Assess the skin irritation, pain, seal effectiveness, and clinician usability of the Comfort Release® drape. 2. Provide Clinical Validation: Gather data for FDA 510(k) clearance, supporting the introduction of a novel NPWT adhesive drape to the market. Purpose: NPWT is commonly used for the management of more than 100 indications, including chronic wounds, acute open wounds, burns, and post operative sites. An estimated 6.5 million patients suffer from chronic wounds, and an estimated 48 million inpatient surgeries are performed each year in the US3,4. NPWT involves covering a wound with an airtight dressing sealed by adhesive and applying sub-atmospheric pressure via a vacuum device. Strong adhesives are typically required for NPWT drapes. Exudate can leak with weaker adhesives, tainting peri-wound skin, reducing drape adherence, and potentially leading to macerated tissue, increased wound size, and slower or reduced healing. However, strong adhesives substantially increase the risk for medical adhesive-associated skin injuries (MARSI) during drape removal/changes. Drape removal can cause epidermal layers to separate and/or detach from the dermis, resulting in skin tears and moisture-associated skin damage, and skin irritation. Studies show the type of drape used correlates with acute pain during dressing changes and injury to the peri-wound tissue, in turn delaying the wound healing process. Previous attempts to develop a product with strong adhesion and easy removability have fallen short. Silicone adhesives have poor skin adherence and are expensive, thus requiring stronger adhering acrylic sealing strips or other acrylic components to mitigate leaks. Addressing this unmet need, Global Biomedical Tech Покажи пълното описание...

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.