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.