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Surgical drape with a releasable acrylic adhesive for atraumatic negative pressure wound therapy

Award Number: R44EB036280
ORGANIZATION: NATIONAL INSTITUTE Of BIOMEDICAL IMAGING & BIOENGINEERING
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/13/2024
PERIOD OF PERFORMANCE END DATE: 08/31/2026

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Surgical drape with a releasable acrylic adhesive for atraumatic negative pressure wound therapy - Abstract – Negative pressure wound therapy (NPWT) is commonly used for the management of a broad spectrum of more than 100 indications, including chronic wounds, acute open wounds, burns, and post operative care. An estimated 6.5 million patients suffer from chronic wounds and an estimated 48 million inpatient surgeries are performed each year in the US. NPWT involves covering a wound with an airtight dressing, sealed by adhesive, and applying sub-atmospheric pressure. If the NPWT drape is not strongly adhered, maceration of tissue surrounding the wound due to leaking exudate can increase the wound size and slow the healing, eventually leading to the loss of the adherence of the drape to the skin. However, strong adhesives substantially increase the chances for medical adhesive-related skin injuries (MARSI) during drape removal/changes. NPWT patients are highly susceptible to this type of secondary trauma. For single use NPWT applications the estimated MARSI incidence rate is between 1-10% whereas serial NPWT users experience MARSI >20% of the time; however, an acceptable MARSI rate should be zero. Studies show that the type of drape used corelates with the amount of acute pain during dressing changes and additional injury to the peri-wound tissue, which can delay the wound healing process. Atraumatic dressings reduce patient pain and stress burden but attempts to develop a product that adheres well yet is easily removed have fallen short. Addressing this unmet need, Global Biomedical Technologies has developed an adhesive acrylic NPWT drape that incorporates innovative ester oligomers that release from the skin via the application of isopropyl alcohol. The underlying technology is a pressure sensitive bioengineered medical adhesive made with oligo (glycerol sebacate) and polyacrylate. This painless adhesive technology, “Comfort Release®,” has been demonstrated to result in high patient satisfaction and decreased nursing time in bandage and tape applications. This project will validate the superior functionality and acceptability of Comfort Release® NPWT drapes against the state-of-the art (V.A.C. drape by KCI Technologies, Inc.) in both single-use and serial-use NPWT applications. Specific Aims of this Direct-to-Phase II are as follows: 1) Compare performance of Comfort Release® drapes with V.A.C. drapes in single-use NPWT applications in a randomized controlled trial. Post-surgical patients (n=200) will be enrolled at Columbia Presbyterian Hospital and Weill Cornell Medical Center. 2) Compare performance of Comfort Release® drapes with V.A.C. drapes in serial-use NPWT applications in a randomized controlled trial. Chronic wound patients (n=100) will be enrolled at Weil Cornell Medical Center where they will undergo 3 NPWT drape changes per week. At each dressing change and on final dressing removal, qualitative data will be collected from clinicians participating in each aim to assess clinician acceptability of the Comfort Release® drape. Successful completion of this project is expected to yield the data needed to support a 510K FDA clearance.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $796,446 )
2025	2025	GLOBAL BIOMEDICAL TECHNOLOGIES LLC	1090 TAILWATER UNIT E	GREENSBORO	GA	30642	GREENE	USA	Discovery and Applied Research for Technological Innovations to Improve Human Health	001	2	8/14/2025	NON-COMPETING CONTINUATION	$796,446
2025	2024	GLOBAL BIOMEDICAL TECHNOLOGIES LLC	1090 TAILWATER UNIT E	GREENSBORO	GA	30642	GREENE	USA	Discovery and Applied Research for Technological Innovations to Improve Human Health	000	1	11/12/2024	NEW	$0
														Subtotal = $796,446

Issue Date FY: 2024 ( Subtotal = $1,216,704 )
2024	2024	GLOBAL BIOMEDICAL TECHNOLOGIES LLC	13901 WILLISTON WAY	NAPLES	FL	34119	COLLIER	USA	Discovery and Applied Research for Technological Innovations to Improve Human Health	000	1	9/13/2024	NEW	$1,216,704
														Subtotal = $1,216,704

Grand Total All Awards = $2,013,150

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Surgical drape with a releasable acrylic adhesive for atraumatic negative pressure wound therapy

Award Number: R44EB036280

ORGANIZATION: NATIONAL INSTITUTE Of BIOMEDICAL IMAGING & BIOENGINEERING

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/13/2024

PERIOD OF PERFORMANCE END DATE: 08/31/2026

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