Sutureless Adult Voluntary Male Circumcision with Topical Anesthetic: A Randomized Field Trial of Unicirc, a Single-Use Surgical Instrument

INTRODUCTION The World Health Organization has solicited rapid and minimally invasive techniques to facilitate scale-up of voluntary medical male circumcision (VMMC). STUDY DESIGN Non-blinded randomized controlled field trial with 2:1 allocation ratio. PARTICIPANTS 75 adult male volunteers. SETTING Outpatient primary care clinic. INTERVENTION Open surgical circumcision under local anesthetic with suturing vs. Unicirc disposable instrument under topical anesthetic and wound sealing with cyanoacrylate tissue adhesive. PRIMARY OUTCOME Intraoperative duration. SECONDARY OUTCOMES Intraoperative and postoperative pain; adverse events; time to healing; patient satisfaction; cosmetic result. RESULTS The intraoperative time was less with the Unicirc technique (median 12 vs. 25 min, p < 0.001). Wound healing and cosmetic results were superior in the Unicirc group. Adverse events were similar in both groups. CONCLUSIONS VMMC with Unicirc under topical anesthetic and wound sealing with cyanoacrylate tissue adhesive is rapid, heals by primary intention with superior cosmetic results, and is potentially safer and more cost-effective than open surgical VMMC. TRIAL REGISTRATION Clinicaltrials.gov NCT02443792.