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 Technologies has developed an adhesive acrylic NPWT drape incorporating innovative ester oligomers that release from the skin with the addition of isopropyl alcohol. This painless adhesive technology, "Comfort Release®," has proven high patient satisfaction with a low incidence of MARSI. This project will confirm the superior functionality and acceptability of Comport Release® NPWT drapes against the market leader (V.A.C. drape by KCI Technologies, Inc.), or standard drape, in both single-use and serial-use NPWT applications. The data obtained from this Direct to Phase II project is expected to support a 510K FDA clearance.

   The proposed research aims to provide the clinical validation and data needed for a 510 (k) FDA clearance. If successful, the knowledge gained as a result of this trial can bring to market a novel surgical drape for wound therapy that has strong potential to be pain-free and atraumatic and will help facilitate wound healing. This can potentially contribute to improved patient outcomes. Given that there are minimal risks in this trial, we find it reasonable to obtain the knowledge and clinical data needed to bring this drape to pursue FDA clearance and bring this novel NPWT drape to market.

   Addressing this, Global Biomedical Technologies will compare Comfort Release® NPWT drape with an innovative "switchable adhesive" technology for painless and trauma free removal with the standard KCI V.A.C.® drape in post-surgical wound patients. The types of post-op wounds that receive NPWT that are eligible for this study include adult acute wounds and incisions, as well as chronic wounds and burns.

   ________________________________________

   Study Design:

   Single-Center, Two-Armed, Randomized Trial

   • Aim 1: Short-duration use (200 patients):

     o Assess single-use (in most cases) application, skin irritation, pain at removal, and seal effectiveness.

     • Study duration: Approximately 2 years.
     • Population: General post-surgical patients.

   • Aim 2: Serial-use application (100 patients):

     • Assess cumulative effects, including MARSI incidence, narcotic usage, compliance, and leak rates.
     • Study duration: Approximately 2 years.
     • Population: Chronic wound patients undergoing serial NPWT.

   Assessments:

   • Skin Irritation and Injury:

   • Tool: MARSI scoring system (erythema, tension blisters, maceration, etc.).

   • Immediate and 30-minute post-removal assessments.

     • Pain Evaluation:

   • Scale: Indiana Polyclinic Combined Pain Scale (0-10).

     • Seal Effectiveness:

   • Leak incidence recorded by clinicians.

     • Treatment Compliance:

   • Monitoring adherence to prescribed NPWT regimens.

     • Medication Use:

   • Tracking pain and stress-reducing medication usage.

     • Clinician Acceptability:

   • Documented via case report forms.

   Risk Mitigation and Ethical Considerations:

   • Minimal Risks:

     • Potential for skin irritation or discomfort, inherent to NPWT.
     • Breach of confidentiality mitigated through deidentification and secure data storage.

   • Informed Consent:

     • Lay-language consent forms provided, ensuring participants fully understand study procedures, risks, and benefits.
     • Oversight by Denise Anderson, RN, WCC, with site coordinators.

   • Adverse Event Reporting:

     • Immediate reporting of new risks or adverse events to the Columbia IRB.

   Statistical and Sample Size Justification:

   • Aim 1: 200 patients across two sites (CUIMC, AMC). o Effect size: Moderate (d=0.4); significance at α=0.05 with 80% power.
   • Aim 2: 25/25/50 patients/group (100 total) at three sites (WCM, VMR, and ASBF). o Effect size: Moderate (d=0.6), targeting higher MARSI incidence in chronic cases.

   Sponsor & Principal-Investigator Howard S. Rosing, MD, PhD CEO, Global Biomedical Technologies, LLC 1211 Acorn Knob Greensboro, GA 30642 Contact: hrosing@comfortrelease.com Phone: (m) 239-330-5646

   Principal Investigator:

   Robert John Winchell, MD Chief, Division of Trauma & Burns Weill Cornell Medical Center (WCM) 525 East 68th Street, Room P7-714, Box 116 New York, NY 10065 Contact: row9057@med.cornell.edu Phone: 646-962-8490

   Co-Principal Investigator:

   Jarrod Terrence Bogue, MD Clinical Instructor in Surgery, Columbia University Irving Medical Center (CUIMC) 161 Fort Washington Avenue, Suite 5 New York, NY 10032 Contact: jb3892@cumc.columbia.edu Phone: 203-668-8595

   Co-Principal Investigator:

   Daniel Careage, MD- Careaga Plastic Surgery 220 Alhambra Circle, First Floor Coral Gables, FL 33134 Absolute Medical Center (AMC) 5040 Northwest 7th Street Suite 500 Miami, Florida 33126 Contact: Juan Diaz drdiaz@absolutemedicalcenter.com> 305-508-0004

   Co-Principal Investigator:

   Deeza Frankel, DPM Vital Medical Research (VMR) 10780 W Flagler ST, Suite #6 Sweetwater, FL 33174 Contact: Alejandro Morlan, APRN Alejandro.m@vitalmedicalresearch.com 305-703-4414

   Co-Principal Investigator:

   Albert Avi Elhiani, DPM All South Bay Footcare/Podiatry Group, Inc. 23365 Hawthorne Blvd., Suite 101 Torrance, CA 90505 Phone: (310) 326-0202

   Second location:

   Eazy Foot & Ankle 9233 W. Pico Blvd, #201 Los Angeles, CA 90035 (424) 279-9332 Contact: Rosie Berrios allsouthbayfootcare@gmail.com 310-326-0202

   IRB Compliance: Advarra IRB serves as the single IRB for all participating sites. Advarra IRB is fully accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP).

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.

Study patient results within the 2 Aims against the control - market leader product results.

Jan 6, 2025

Health care professional status is required. All requests for access will be emailed to danderson@comfortrelease.com.