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

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 (R)) or absorbable (polydioxanone; PDS (R)) 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 (R) and 233 after PDS (R). 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 (R) and 24.9 per cent (58 of 233) with PDS (R) (P = 0.229). Kaplan-Meier analysis showed a cumulative rate after 4 years of 23.7 and 30.2 per cent for Prolene (R) and PDS (R) 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).