Use of bioresorbable membrane (sodium hyaluronate plus carboxymethylcellulose) after controlled bowel injuries in a rabbit model

PURPOSE: Patients in whom enterolysis is performed are at high risk for rec urrence of adhesions and for injury during adhesiolysis. Therefore, the aim of this study was to assess the safety of sodium hyaluronate-based bioreso rbable membrane (Seprafilm(R)) after myotomy and enterotomy. METHODS: A tot al of 60 rabbits underwent laparotomy with equal distribution to one of thr ee groups: creation of either three repaired, or three unrepaired myotomies , or three repaired enterotomies. Thus, a total of 180 defects were created in the same anatomic positions. One-half of the animals in each group had the surface of the myotomies or enterotomies covered by Seprafilm(R). Fourt een days later, after complete absorption of Seprafilm(R), the presence of intra-abdominal abscess, adhesions, and the integrity of the suture line we re evaluated by a surgeon blinded to the use of Seprafilm(R) and by a stand ard radiographic isobaric contrast study. Statistical analysis was done by use of Fisher's exact test; significance was set at P < 0.05. RESULTS: The incidence of adhesions in the repaired myotomy group were 2 (6.6 percent) a nd 9 (30 percent) in the Seprafilm(R) and control (nonSeprafilm(R)) groups, respectively (P < 0.05); in the unrepaired myotomy group, 2 (6.6 percent) and 10 (33 percent) in the Seprafilm(R) and control groups, respectively (P < 0.05); and in the enterotomy group, 28 (94 percent) and 29 (97 percent) in the Seprafilm(R) and control groups, respectively (P = not significant). A single phlegmon occurred in the myotomy group at a Seprafilm(R) site (1. 6 (1/60) vs. 0 percent, P = not significant). There were no leaks in this g roup. In the enterotomy group, the incidence of phlegmons was 33 percent (1 0/30) in the Seprafilmo(R) group, whereas it was 27 percent (8/30) in the n onSeprafilm(R) group (P = not significant). The incidence of leaks was 6.6 (2/30) and 10 percent (3/30) in the Seprafilm(R) and nonbeprafilm(R) group, respectively (P = not significant). CONCLUSION: The use of Seprafilm(R) at the sites of myotomies significantly reduced the incidence of adhesions. E ffectiveness at the enterotomy site may have been attenuated by a greater i nflammatory response. Importantly, Seprafilm(R) did not increase septic mor tality in any group.