Metaanalysis of the safety and efficacy of an adhesion barrier (Interceed TC7) in laparotomy

OBJECTIVE: To evaluate the safety and efficacy of an oxidized, regenerated, cellulose adhesion barrier (Interceed TC7) in the reduction of pelvic adhe sions. STUDY DESIGN: Clinical studies published or completed by December 31, 1994, evaluating the barrier used at laparotomy were considered for a metaanalys is. RESULTS: Of 10 studies (n=560) identified, data from 7 (n=389) met the incl usion criteria for determining the reduction in the incidence of adhesions and 5 (n=312)for determining the reduction in adhesion extent (raw surface area after adhesiolysis). There was a 24.2+/-3.3% difference in the inciden ce of adhesions (P<.001) between barrier-treated and untreated sites. Adhes ion-fi ee 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% co nfidence interval = 2.15-3.90). Barrier treatment resulted in a greater red uction (1.1 +/- 0.4 cm(2)) 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 teas considered to be de finitely related to the use of the barrier. CONCLUSION: The barrier significantly reduced the incidence and extent of a dhesions as compared with Ilo treatment, confirming the conclusion from ind ividual studies that it is safe and effective in pelvic laparotomy surgery.