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Background: The safety and efficacy of Seprafilm (Genzyme Corporation, Cambrid ge, Mass) in adult surgery patients have been established. The aim of this study was to evaluate the safety and efficacy of Seprafilm in pediatric surgical pati ents. Methods: One hundred twenty-two pediatric abdominal surgery patients were enrolled. Sixty-seven patients received Seprafilm application. Of these patien ts, 18 again received Seprafilm at abdominal closure during a second surgery, an d of the 18, 4 received Seprafilm at closure after a third surgery. Of the 55 co ntrol patients who did not receive Seprafilm, 14 had a second surgery, and of th ese 14 patients, 4 had a third surgery. Adverse events, operation time, and bloo d loss were compared with assessed Seprafilm safety. Seprafilm efficacy evaluati ons included incidence and severity of adhesions in those patients who required relaparotomy. Results: The incidence (Seprafilm, 40.9%; control, 82.4%) and se verity (Seprafilm: 59.1%, grade 0; control: 17.6%, grade 0) of adhesions under the abdominal incision site were significantly reduced in the Seprafilm group ( P = .007 and P = .0009, respectively). In addition, mean relaparotomy operation time was significantly shorter for Seprafilmpatients (P = .004). At relaparotomy , blood loss/body weight ratio for Seprafilm patients compared with control pati ents showed a trend toward but did not reach significance (P = .09). Conclusions : Decreased incidence and severity of postsurgical adhesions with Seprafilmin pe diatric patientsmay lead to reduction of the risks associated with subsequent op eration.
Background: The safety and efficacy of Seprafilm (Genzyme Corporation, Cambrid ge, Mass) in adult surgery patients have been established. The aim of this study was to evaluate the safety and efficacy of Seprafilm in pediatric surgical pati ents. Methods: One hundred twenty Of these patien ts, 18 second received Seprafilm at abdominal closure during a second surgery, an d of the 18, 4 received Seprafilm at closure after a third surgery. Of the 55 co ntrol patients who did not receive Seprafilm, 14 had a second surgery, and of th ese 14 patients, 4 had a third surgery. Adverse events, operation time, and bloo d loss were compared with the assessed Seprafilm safety. Seprafilm efficacy evaluati ons included incidence and severity of adhesions in those patients who required relaparotomy. Results: The incidence (Seprafilm, 40.9%; control, 82.4%) and se verity (Seprafilm: 59.1%, grade 0; co ntrol: 17.6%, grade 0) of adhesions under the abdominal incision site were significantly reduced in the Seprafilm group (P = .007 and P = .0009, respectively). In addition, mean relaparotomy operation time was significantly shorter for Seprafilmpatients (P = .004). At relaparotomy, blood loss / body weight ratio for Seprafilm patients compared with control pati ents showed a trend toward but did not reach significance (P = .09). Conclusions: Decreased incidence and severity of postsurgical adhesions with Seprafilmin pe diatric patientsmay lead to reduction of the risks associated with subsequent op eration.