New adhesion barrier heads for multicenter trial. (Initial Study Included 14 Women).

SAN DIEGO -- A sprayable adhesion barrier being used in Europe performed well enough in a U.S. feasibility study to justify a pivotal trial, Dr. D. Alan Johns said at the World Congress on Endometriosis.

The hydrogel barrier, which is known as SprayGel, was tested on 14 women in the United States who were undergoing laparoscopic bilateral adnexal surgery for endometriosis or for lysis of adhesions, said Dr. Johns of the Texas Institute of Clinical Research in Fort Worth.

Each woman served as her own control, with one ovary randomly selected to receive the hydrogel barrier after surgery. The barrier was not applied to the other ovary.

Videotapes taken at the initial laparoscopy and at a second-look laparoscopy 3-6 weeks after the surgery were reviewed by a surgeon who did not know which side had received the hydrogel product.

The barrier decreased the incidence of postoperative adhesions by 71%, decreased the extent of adhesions by 69%, and decreased adhesion severity by 43% on the sides sprayed with the hydrogel, compared with the unsprayed sides. Surgeons removed any adhesions found on second-look laparoscopy on both the treated and untreated sides.

The maker of the sprayable adhesion barrier, Confluent Surgical Inc. of Waltham, Mass., funded the initial trial.

Confluent Surgical Inc. also is starting a multicenter pivotal trial of the product in an effort to win Food and Drug Administration approval for the indication of preventing development of adhesions after the performance of laparoscopic surgery on adnexal structures.