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