Evaluation of a New Advanced Barrier Film to protect wounds from simulated incontinence fluid in a porcine model

A porcine model was used to test a new therapy for patients who suffer from incontinence-associated dermatitis or general loss of skin integrity. The objective was to evaluate the process of re-epithelialization in the continued presence of simulated incontinence fluid. Seven Yorkshire pigs were prepped for sterile field surgery. On each pig, ten partial thickness wounds (2 x 2 in) were created using a dermatome set to 0.5 mm thickness (5 on each side of the spine). Pressure was applied for 5 minutes with a gauze pad to reduce drainage. Treatments were applied in a randomized fashion, using 35 sites for the control group (uncoated) and 35 sites for the treatment (coated with the new barrier film). The film was allowed to dry for 5 minutes. The wounds were challenged with simulated incontinence fluid (pancreatin in alkaline solution, pH 9) using an occlusive patch test system and then covered with a foam dressing. After 96 hours, samples were excised from each wound for histological evaluation of re-epithelialization. Data was analyzed using a mixed model analysis of variance, with treatment group as a fixed factor in the analysis, and pig and pig-by-treatment group as random factors. The percent of re-epithelialization was significantly greater for the wounds covered with the new barrier film than for the control wounds (p=0.003; on average, 18.3% greater, with a 95% confidence interval of 9.2% to 27.5%). Treated wounds had consistent, continuous, long stretches of re-epithelialized epidermis frequently displaying elongated rete pegs similar to native epidermis. Control wounds had inconsistent, less linear and more disorganized epidermis as well as foreign material from the patch. In this experiment, the new barrier film provided an environment for re-epithelialization to occur in the continued presence of a simulated incontinence fluid over a period of 96 hours and protected wounds from debris.