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.


METHODS
Prospective, controlled two-phase porcine study.


METHODS
Good Laboratory Practice-certified animal facility.


METHODS
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.


METHODS
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.


METHODS
Presence or absence of adhesions.


RESULTS
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.


CONCLUSIONS
The PROACT System appears to be safe and efficacious in reducing adhesions to the laparotomy incision line in the porcine model.
Diamond
Michael P
MP
Department of Obstetrics and Gynecology, Wayne State University School of Medicine, Detroit, Michigan 48201, USA. mdiamond@med.wayne.edu
Stecco
Kathy
K
Paulson
Amelia J
AJ
D000818:Animals; D007421:Intestine, Small / Q000601:surgery; D007813:Laparotomy / Q000295:instrumentation*; D010532:Peritoneal Diseases / Q000517:prevention & control*; D011183:Postoperative Complications / Q000517:prevention & control*; D011446:Prospective Studies; D011897:Random Allocation; D013552:Swine; D000267:Tissue Adhesions / Q000517:prevention & control*