Evaluation of a bioresorbable polylactide sheet for the reduction of pelvic soft tissue attachments in a porcine animal model

Abstract

In an adult porcine model, the effectiveness of a bioresorbable film to minimize soft tissue attachment to the pelvic viscera was evaluated at 4-week and 12-week endpoints. Following a transperitoneal laparotomy through a midline incision, the bladder and uterus were abraded in all animals to promote soft tissue attachment to the viscera. Control animals received no further treatment. The experimental group animals were treated with bioresorbable polylactide (PLa) sheets, 0.02 mm thick, one between the bladder and the abdominal wall, and a second sheet between the bladder and the uterus. Quantitative assessment of the severity and location of soft tissue attachments, and qualitative histologic assessment were performed at 4 and 12 weeks post-operatively. Statistically significant differences in the quantitative soft tissue attachment scores were observed in comparing the PLa film treated animals versus the control animals, at both the 4-week and 12-week time points. In the control animals, the formation of numerous thick fibrous bands was observed at both time points. Histology revealed no adverse reaction to the bioresorbable PLa barrier film. The bioresorbable PLa sheet provided an effective barrier between adjacent anatomical structures and minimized soft tissue attachments to the device when in contact with the viscera as compared to the control groups. Surgical dissection planes between the abdominal wall and adjacent soft tissues were maintained with the use of the PLa sheet at both time points.