Effect of oxiplex∗ films (PEO/CMC) on adhesion formation and reformation in rabbit models and on peritoneal infection in a rat model

Abstract

Objective: To assess the efficacy of Oxiplex (FzioMed, Inc., San Luis Obispo, CA) barriers. Design: Film of polyethylene oxide and carboxymethylcellulose (Oxiplex) were tested for strength and tissue adherence. Films were selected for evaluation in models for biocompatability and adherence. Three films were selected for evaluation in efficacy studies, and one was evaluated for effects on bacterial peritonitis. Handling characteristics of Oxiplex film were evaluated via laparoscopy. Setting: University laboratory. Patient(s): Rabbits, rats, pigs. Intervention(s): Placement of Oxiplex prototypes at the site of injury. Main Outcome Measure(s): Mechanical properties, biocompatibility, tissue adherence, adhesion development, infection potentiation, and device handling. Result(s): Mechanical tests indicated that tensile strength and elongation were inversely correlated. All films tested had excellent tissue adherence properties. Selected films, based on residence time and biocompatibility, prevented adhesion formation in all animals and were highly efficacious in preventing adhesion reformation. The optimal Oxiplex prototype prevented adhesion reformation in 91% of the animals. This Oxiplex film, dyed to allow visualization, prevented adhesion reformation and did not affect bacterial peritonitis. In a laparoscopic model, the Oxiplex film, delivered in FilmSert forceps, via a 5.0-mm trocar, rapidly unfurled and could be easily applied to tissue with strong adherence. Conclusion(s): These data show development of an adhesion prevention material that is tissue adherent, can be placed via laparoscopy, and does not affect host resistance.