Efficacy and safety of two disposable circumcision suture devices for circumcision in adults: a prospective comparative multicenter study.

Abstract

The objective of this study was to evaluate and compare efficacy and safety of two different Disposable circumcision suture devices (DCSDs). A prospective comparative non-randomized multicenter study was performed between November 2019 and February 2023. Patients underwent circumcision using a DCSD (CircCurer^TM or the ZSR^® device) according to the surgeon preference and device availability. A total of 378 patients were circumcised; 184 using CircCurer^TM and 194 patients using ZSR^®. No differences in baseline characteristics were observed. CircCurer and ZSR Groups showed similar rates of operative time (7.7 ±2.1 vs 7.3 ±2.0 min), surgical site infection (1.1% Vs 1.5%), edema (13% Vs 8.2%), hematomas (2.7% Vs 1.1%), and postoperative pain (2.5 Vs 2.0 points). ZSR Group had a significantly higher rate of clip fallout (62.9% Vs 38%, p < 0.001). At 2 months, patients of both groups reported a median satisfaction of 9 (8-9) points. Main limitation consist in non-randomized study. DCSDs seem to be effective and safe, with short operative times, uncommon and mild complications, and high patient satisfaction. ZSR^® device has a higher rate of spontaneous staple dropout.