Prototype Development and Clinical Testing of a Temperature-Sensitive High-Adhesion Medical Tape to Reduce Medical-Adhesive Related Skin Injury and Improve Quality of Care

Abstract

Medical adhesives are used to secure wound care dressings and critical devices to the skin. Without means for safe removal, these strong adhesives are difficult to painlessly remove from the skin, and often result in medical adhesive related skin injuries (MARSI), which can take weeks to heal and increase the risk of infection. Alternatively, to avoid MARSI, lower adhesion medical tapes are chosen, leading to device dislodgement and further medical complications. ThermoTape is a high adhesion medical tape designed for low skin trauma upon release. By warming the skin-attached tape prior to removal, a significant loss in adhesion is achieved, allowing for more rapid, painless, and injury-free removal. A C14/C18 acrylate copolymer was developed and combined with a selected pressure sensitive adhesive material. This formulation was applied as a wet film on a thin backing substrate and heated to remove solvents. The addition of 1% C14/C18 acrylate copolymer yielded the largest temperature responsive drop in adhesion to a surface and was further refined by control of film drying times and temperature. The adhesive film was characterized with AFM, where distinct nanodomains were identified on the exterior surface of the pressure sensitive adhesive. After heating above the melting point of the additive, these nanodomains contribute to a reduction in the adhesive peel force perhaps by weakening the adhesive-substrate boundary layer. ThermoTape was clinically tested in a 53-subject comparative single-blind clinical trial. ThermoTape was benchmarked with Tegaderm™ (high adhesion) and Kind Removal Tape (KRT- low adhesion). All three tapes were applied to both the left and right forearm and were removed 24 hours later, the right arm without heat and the left arm by directly applying a heat pack for 30 seconds. There were clinically and statistically significant results supporting reduced pain of ThermoTape with warming, with an average of 58% decrease in pain, which is paired with a statistically significant 45% reduction in skin redness. In contrast, there were statistically insignificant differences in pain and redness for Tegaderm™ and KRT with warming. These results provide compelling evidence that warming ThermoTape prior to removal can reduce pain and injury when compared to standard medical tapes. This could allow for stronger attachment of wound care dressings and critical medical devices while reducing the cases of MARSI. Two ThermoTape prototypes were fabricated with two different PSA thicknesses, representing two different use cases, and demonstrating the tunability of the ThermoTape system. Increasing the thickness enabled a higher peel force at 25ºC, accompanied by a release similar to KRT. Several pilot studies were conducted to further refine the design, demonstrate long-term wear, test different PSA thicknesses, and to prepare for clinical testing at Harborview Medical Center. A manufacturing plan was developed to transition ThermoTape from the lab to high volume manufacturing.