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.