Skin Protectants Made of Curable Polymers: Effect of Application on Local Skin Temperature.

Objective: To measure the skin temperature after application of a new skin protectant intended for incontinence-associated dermatitis (IAD), compared with a commercial product with an analogous cyanoacrylate-based chemistry. Approach: Twelve healthy human volunteers received an application of the new product on one thigh and of the comparator on the other thigh. An infrared camera using ThermaCAM™ software imaged the skin and measured the temperature at the skin surface over time to characterize the thermal cure profile induced by the products on the skin. Results: The new product led to a drop in skin surface temperature (endothermic reaction), whereas the commercial product displayed an exotherm and a slight rise in skin surface temperature. Innovation: Cyanoacrylate-based chemistries come in various formulations, differing in the side chains and additives used. They are liquid monomers that polymerize after application, and this polymerization is accompanied by an exothermic reaction that can be perceived as an unpleasant warming sensation, especially on compromised skin. A new formulation was designed to mitigate this rise in temperature. Conclusion: The new skin protectant may potentially be more comfortable for IAD patients, since it causes a drop in skin surface temperature instead of a rise during the curing process that follows application.

In vivo methods to evaluate a new skin protectant for loss of skin integrity.

A new skin protectant was developed for use on conditions involving partial-thickness skin loss such as severe incontinence-associated dermatitis. This new formulation is based on a cyanoacrylate chemistry designed to polymerize in situ and create a breathable film able to protect the skin surface from external irritants. This film provides an environment favorable for healing to occur beneath the film. To evaluate the characteristics of the novel chemistry, we devised a preclinical testing strategy comprising three different animal models. The data from all three models was considered collectively to create an overall assessment of effectiveness. A guinea pig model was used to evaluate the barrier efficacy of the new product in protecting intact skin from irritation. A porcine partial-thickness wound model was used to evaluate the efficacy of the product in helping control minor bleeding and exudate. A similar model was also used to assess the process of reepithelialization in the continued presence of an irritant. In the first model, untreated sites had 8.5 times more irritation than sites covered with the new product (p < 0.001). In the second model, a single application of the new product successfully attached to intact peri-wound skin and to denuded, weepy skin. It significantly reduced the amount of fluid weeping from the wounds (p ≤ 0.001) and continued to perform throughout a 96 hours experiment. In the third model, the percent of reepithelialization was significantly greater for the wounds covered with the new product than for the control wounds (p = 0.003; on average, 18.3% greater, with a 95% confidence interval of 9.2% to 27.5%). These results suggest that the new skin protectant protects intact and denuded skin from irritants and provides an environment favorable to healing, offering promise for the management of various conditions involving loss of epidermis.