Use of the PROACT System for reduction of postsurgical peritoneal adhesions.

OBJECTIVE

To assess the efficacy and safety of a new surgical device designed to prevent adhesions.

DESIGN

Prospective, controlled two-phase porcine study.

SETTING

Good Laboratory Practice-certified animal facility.

ANIMAL(S): Phase I: 10 pigs underwent peritoneal treatment with the PROACT System (NTERO Surgical, Inc., Palo Alto, California) at the time of the laparotomy incision, and four had the incision made without treatment. Phase II: 22 animals were randomized to treatment or control groups.

INTERVENTION(S): Animals in both groups underwent laparotomy incision and small bowel resection. The treatment group received treatment to the peritoneum before the peritoneal incision was made. Necropsy and adhesion evaluation were conducted by a blinded reviewer 7-13 days after the initial surgery.

MAIN OUTCOME MEASURE(S): Presence or absence of adhesions.

RESULT(S): Phase I: no treated animal developed adhesions to the incision site; three of four control animals developed adhesions to the incision site. Phase II: 4 of 10 control animals and no treated animals developed midline abdominal wall adhesions. Distal adhesions tended to also be reduced in treated animals. No side effects or increased risks were noted.

CONCLUSION(S): The PROACT System appears to be safe and efficacious in reducing adhesions to the laparotomy incision line in the porcine model.