Randomized clinical trial comparing polypropylene or polydioxanone for midline abdominal wall closure

Abstract

Abstract Background Incisional hernia is a frequent complication of abdominal surgery, often requiring surgical intervention. This prospective randomized trial compared suture materials for closure of the fascia after abdominal surgery. Methods In 456 patients the abdominal fascia was closed with either non-absorbable (polypropylene; Prolene®) or absorbable (polydioxanone; PDS®) suture material. Follow-up was by clinical examination and ultrasonography at 6-month intervals. Outcome measures were incisional hernia, surgical-site infection and suture sinus. Results Some 223 patients were analysed after closure with Prolene® and 233 after PDS®. Median follow-up was 32 and 31 months respectively. There was no significant difference in the incidence of incisional hernia between the groups: 20·2 per cent (45 of 223) for Prolene® and 24·9 per cent (58 of 233) with PDS® (P = 0·229). Kaplan-Meier analysis showed a cumulative rate after 4 years of 23·7 and 30·2 per cent for Prolene® and PDS® respectively (P = 0·222). Secondary outcome measures showed no significant differences. Conclusion The incidence of incisional hernia in both groups was higher than expected from previous literature. There were no significant differences between the two suture methods. Registration number: ISRCTN65599814 (http://www.clinical-trials.com).