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

Abstract

The World Health Organization has solicited rapid and minimally invasive techniques to facilitate scale-up of voluntary medical male circumcision (VMMC).Non-blinded randomized controlled field trial with 2:1 allocation ratio.75 adult male volunteers.Outpatient primary care clinic.Open surgical circumcision under local anesthetic with suturing vs. Unicirc disposable instrument under topical anesthetic and wound sealing with cyanoacrylate tissue adhesive.Intraoperative duration.Intraoperative and postoperative pain; adverse events; time to healing; patient satisfaction; cosmetic result.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.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.Clinicaltrials.gov NCT02443792.