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 adhesions.


METHODS
Clinical studies published or completed by December 31, 1994, evaluating the barrier used at laparotomy were considered for a metaanalysis.


RESULTS
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.


CONCLUSIONS
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.
D002483:Cellulose, Oxidized / Q000627:therapeutic use*; D005260:Female; D005831:Genital Diseases, Female / Q000601:surgery*; D006801:Humans; D015994:Incidence; D007813:Laparotomy / Q000009:adverse effects*; D012086:Reoperation; D012107:Research Design; D012449:Safety; D012720:Severity of Illness Index; D000267:Tissue Adhesions / Q000145:classification / Q000209:etiology* / Q000517:prevention & control*; D016896:Treatment Outcome