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
Cite this article
Franklin, R. R. (1995). Reduction of ovarian adhesions by the use of Interceed. Ovarian Adhesion Study Group. Obstetrics and gynecology, 86(3), 335-340. https://doi.org/10.1016/0029-7844(95)00175-q
Franklin RR. Reduction of ovarian adhesions by the use of Interceed. Ovarian Adhesion Study Group. Obstet Gynecol. 1995;86(3):335-340. doi:10.1016/0029-7844(95)00175-q
Franklin, R. R. "Reduction of ovarian adhesions by the use of Interceed. Ovarian Adhesion Study Group." Obstetrics and gynecology, vol. 86, no. 3, 1995, pp. 335-340.
To evaluate the safety and efficacy of an oxidized, regenerated, cellulose adhesion barrier (Interceed TC7) in the reduction of pelvic adhesions. Clinical studies published or completed by December 31, 1994, evaluating the barrier used at laparotomy were considered for a metaanalysis. Of 10 studies (n = 560) identified, data from 7 (n = 389) met the inclusion criteria for determining the reduction in the incidence of adhesions and 5 (n = 311) for determining the reduction in adhesion extent (raw surface area after adhesiolysis). There was a 24.2 +/- 3.3% difference in the incidence of adhesions (P < .001) between barrier-treated and untreated sites. Adhesion-free outcomes were 1.5-2.5 times more likely at barrier-treated sites than at sites with good surgical technique alone (odds ratio = 2.89; 95% confidence interval = 2.15-3.90). Barrier treatment resulted in a greater reduction (1.1 +/- 0.4 cm2) in adhesion extent (raw surface area) than good surgical technique alone (P < .001). Four adverse events were recorded; they were typical of those seen after surgery. No event was considered to be definitely related to the use of the barrier. The barrier significantly reduced the incidence and extent of adhesions as compared with no treatment, confirming the conclusion from individual studies that it is safe and effective in pelvic laparotomy surgery.
Nordic Adhesion Prevention Study Group, 1995·Fertil Steril
To evaluate the efficacy of Interceed as an adjuvant in the prevention of postoperative adhesion reformation to the ovary, fallopian tube, and fimbria when used together with microsurgical techniques. Prospective, randomized, multicenter, controlled clinical study. Normal human volunteers in an academic research environment. Sixty-six women suffering from infertility due at least in part to bilateral tubal disease with bilateral adhesions attached to ovaries, fallopian tubes, and fimbriae. Adhesiolysis bilaterly through laparotomy with microsurgical techniques, application of Interceed on one of the sides randomly assigned not known by the surgeon before application, follow-up laparoscopy 4 to 10 weeks postoperatively, with each patient serving as her own control. Adhesion severity scores at all sites and number of adhesion free organs after laparotomy and follow-up laparoscopy. When the initial scores registered at the operation for fertility were compared with those registered at the second-look laparoscopy, the results indicated that gentle microsurgical techniques resulted in a significant reduction of postoperative adhesions. Adnexa, which were covered with Interceed, had significantly lower adhesion scores than the control adnexa, representing an improvement of 39% compared with microsurgery alone (control) in reducing adhesion reformation scores. When combined with microsurgical techniques, Interceed reduced adhesion reformation scores by 70%. The number of ovaries, fallopian tubes, and fimbriae without adhesions at the time of second-look laparoscopy was significantly increased by approximately twofold when organs were covered with Interceed. In a prospective, randomized, multicenter, controlled clinical study using a protocol in which other adjuvants have been shown not to be efficacious, Interceed was shown to reduce significantly the incidence and severity of adhesion reformation to the ovary, fallopian tube, and fimbria after infertility surgery.
To (1) review the events leading to peritoneal adhesion formation; (2) review traditional adhesion prevention adjuvants; (3) overview studies for adhesion prevention barriers including a perspective for their use; and (4) look toward the future of adhesion prevention. A great deal of effort has been dedicated to reduce adhesion formation because of the morbidity associated with adhesions and the associated economic burden, which considering only hospital costs and surgeons' fees, was $1,180 million in the United States. To understand the role of adhesion barriers in gynecological surgery, an appreciation of the cellular cascade and temporal nature of peritoneal repair is necessary. Evidence indicates that areas denuded of peritoneum will heal satisfactorily and that suturing of the peritoneum may increase adhesion formation. Physical barriers, including both mechanical and viscous solutions, are widely used to prevent adhesion formation by limiting tissue apposition during the critical stages of mesothelial repair. Clinical studies do not support the use of intraperitoneal, dextran for adhesion prevention. Theoretical considerations of peritoneal fluid dynamics indicate that crystalloid instillates should not prevent adhesion formation because of their short intraperitoneal residence. This prediction is consistent with clinical observation. The availability of Interceed (Johnson and Johnson Medical, Inc., Arlington, TX) and Gore-Tex Surgical Membrane (W.L. Gore, Flagstaff, Arizona) barriers provides substantial progress in postsurgical adhesion prevention. Although many investigators are incorporating adhesion prevention barriers into their routine clinical situations, physician acceptance is constrained by technical difficulties.
Eight patients with extensive adhesions and 10 undergoing myomectomy had Gore-Tex surgical membranes placed to prevent adhesion formation/reformation. At the time of second-look laparoscopy, the membranes were removed easily, and the extent of adhesion was minimal. Further studies are ongoing to validate these findings and to compare the Gore-Tex surgical membrane with antiadhesion agents.