Abstract
Objective To evaluate the efficacy of Interceed (TC7) Absorbable Adhesion Barrier, an oxidized regenerated cellulose fabric, as a barrier to the development of postsurgical ovarian adhesions after surgery involving the ovaries.
Methods In a multicenter randomized study, 55 patients with bilateral ovarian disease were treated at initial laparotomy. At the end of the procedure, one ovary was assigned randomly to be wrapped with Interceed and the other was left uncovered. A second-look laparoscopy was performed 10-98 days later to evaluate the occurrence and severity of adhesions and the raw ovarian surface area exposed after lysis of adhesions.
Results At second-look laparoscopy, 26 of 55 Interceed-treated ovaries were free of adhesions, compared with 14 of 55 untreated control ovaries, a statistically significant difference (P = .028, Fisher exact test). At second-look laparoscopy, ovaries treated with Interceed formed adhesions less extensively (1.66 +/- 0.34 cm2) than did untreated ovaries (2.75 +/- 0.60 cm2) and with a greater reduction of raw ovarian surface area (difference in area differential -1.89 +/- 0.96 cm2; P = .055, paired t test). Adhesion scores at second-look laparoscopy were reduced significantly for ovaries treated with Interceed compared with untreated ovaries (P = .02, Wilcoxon signed-rank test). No adverse events were recorded during the course of the study.
Conclusion Treatment of ovaries with Interceed significantly reduced the occurrence and severity of postsurgical ovarian adhesions.
Interceed adhesion barrier ovarian surgery randomized trial, oxidized regenerated cellulose postsurgical ovarian adhesion prevention, bilateral ovarian disease laparotomy adhesion reduction, second-look laparoscopy adhesion assessment after ovarian surgery, TC7 absorbable adhesion barrier ovary multicenter study, postsurgical ovarian adhesion prevention barrier methods, Franklin Interceed ovarian adhesion study group, adhesion score reduction ovarian surgery randomized controlled trial, raw ovarian surface area adhesion lysis outcomes, fertility surgery adhesion prevention absorbable barrier
PMID 7651638 7651638 DOI 10.1016/0029-7844(95)00175-q 10.1016/0029-7844(95)00175-q
Keywords
Adult, Cellulose, Oxidized/therapeutic Use, Female, Humans, Matched-Pair Analysis, Ovarian Diseases/prevention & Control/surgery, Postoperative Complications/pathology/prevention & Control, Reoperation, Severity of Illness Index, Tissue Adhesions/prevention & Control, Treatment Outcome, Cellulose, Oxidized, INTERCEED