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

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).