A temperature-sensitive, high-adhesion medical tape: a comparative, single-blind clinical trial.

OBJECTIVE: Medical adhesives are used to secure wound care dressings and other critical devices to the skin. While high peel-strength adhesives provide more secure skin attachment, they are difficult to remove from the skin and are correlated with medical adhesive-related skin injuries (MARSI), including skin tears, and an increased risk of infection. Lower-adhesion medical tapes may be applied to avoid MARSI, leading to dressing or device dislodgement and further medical complications. METHOD: This paper reports on the clinical testing of a new, high-adhesion medical tape, ThermoTape (University of Washington, US), designed for low skin trauma upon release. ThermoTape was benchmarked with Tegaderm (3M, US) and Kind Removal Tape (KRT) (3M, US). All three tapes were applied to both the left and right forearm of healthy volunteers and were removed 24 hours later-the right arm without applying heat and the left arm by applying a heat pack for 30 seconds before removal. Tape wear, self-reported pain (0-10 scale) and skin redness 15 minutes after removal were recorded. RESULTS: This was a 53-subject comparative, single-blind clinical trial. There were clinically and statistically significant results supporting reduced pain during removal of ThermoTape with warming, with an average 58% decrease in pain, paired with a statistically significant 45% reduction in skin redness (p<0.01 for both values). In contrast, there were statistically insignificant differences in pain and redness for removal of Tegaderm and KRT with warming. ThermoTape after warming, in comparison with Tegaderm without warming, produced a reduced pain score of >1 on the 0-10 Wong-Baker/Face pain scale, which was statistically significant (p<0.01). CONCLUSION: These results provide compelling evidence that warming ThermoTape prior to removal can reduce pain and injury when compared with standard medical tapes. This could allow for stronger attachment of wound care dressings and critical medical devices while reducing cases of MARSI.

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

Medical adhesives are used to secure wound care dressings and other critical devices to the skin. Without means of safe removal, these stronger adhesives are difficult to painlessly remove from the skin and may cause medical-adhesive-related skin injuries (MARSI), including skin tears and an increased risk of infection. Lower-adhesion medical tapes may be applied to avoid MARSI, leading to device dislodgement and further medical complications. This paper outlines the development of a high-adhesion medical tape designed for low skin trauma upon release. By warming the skin-attached tape for 10-30 s, a significant loss in adhesion was achieved. A C14/C18 copolymer was developed and combined with a selected pressure-sensitive adhesive (PSA) material. The addition of 1% C14/C18 copolymer yielded the largest temperature-responsive drop in surface adhesion. The adhesive film was characterized using AFM, and distinct nanodomains were identified on the exterior surface of the PSA. Our optimized formulation yielded 67% drop in adhesion when warmed to 45 °C, perhaps due to melting nanodomains weakening the adhesive-substrate boundary layer. Pilot clinical testing resulted in a significant decrease in pain when a heat pack was used for removal, giving an average pain reduction of 66%.

Chitosan-based composite bilayer scaffold as an in vitro osteochondral defect regeneration model.

Prolonged osteochondral tissue damage can result in osteoarthritis and decreased quality of life. Multiphasic scaffolds, where different layers model different microenvironments, are a promising treatment approach, yet stable joining between layers during fabrication remains challenging. Here, a bilayer scaffold for osteochondral tissue regeneration was fabricated using thermally-induced phase separation (TIPS). Two distinct polymer solutions were layered before TIPS, and the resulting porous, bilayer scaffold was characterized by seamless interfacial integration and a mechanical stiffness gradient reflecting the native osteochondral microenvironment. Chitosan is a critical component of both scaffold layers to facilitate cell attachment and the formation of polyelectrolyte complexes with other biologically relevant natural polymers. The articular cartilage region was optimized for hyaluronic acid content and stiffness, while the subchondral bone region was defined by higher stiffness and osteoconductive hydroxyapatite content. Following co-culture with chondrocyte-like (SW-1353 or mesenchymal stem cells) and osteoblast-like cells (MG63), cell proliferation and migration to the interface along with increased gene expression associated with relevant markers of osteogenesis and chondrogenesis indicates the potential of this bilayer scaffold for osteochondral tissue regeneration.