Adhesion prophylaxis using a copolymer with rationally designed material properties.

BACKGROUND: Physical barriers are the only licensed adjuncts for adhesion prophylaxis in the United States and Europe. Here, we investigate D,L-polylactide-epsilon-caprolactonetrimethylenecarbonate (PCT copolymer), which is a rationally designed biomaterial, as an adhesion barrier.
METHODS: PCT copolymer membranes were produced by polymerization of the monomers, dissolution in organic solvents, and subsequently processing them by means of modified phase inversion and freeze drying. In vitro cytotoxicity was assayed by fibroblast culture. In vivo adhesion prophylaxis was studied in a rat model that involved standardized traumatization by electrocautery and suturing. The quantity and quality of the resulting adhesions were scored 14 days postoperatively. Complete autopsy was performed in each animal, and the implantation sites were examined histologically. The suitability for human laparoscopic application was investigated in a patient admitted for routine myomectomy.
RESULTS: The PCT copolymer had no effect on the proliferation of cultured cells in vitro. The in vivo model showed that the quantity of adhesions that cover the traumatized areas was significantly less in animals treated with PCT copolymer membrane (32%) than in untreated animals (78%) (P < .01). Adhesions of both dense and filmy quality were affected. In the animals, autopsy and histologic examination of the relevant tissues revealed no indication of adverse reactions to the PCT copolymer. Human laparoscopic application was successful.
CONCLUSION: The PCT copolymer membrane is biocompatible with the abdominal cavity and decreased adhesions in the animal model. It is also suitable for human laparoscopic application. Therefore, the PCT copolymer represents a candidate for additional clinical evaluation.