Rapid, minimally invasive adult voluntary male circumcision: A randomised trial of Unicirc, a novel disposable device

摘要

BACKGROUND: Voluntary medical male circumcision (VMMC) is a priority HIV preventive intervention. To facilitate VMMC scale-up, the World Health Organization is seeking circumcision techniques that are faster, easier, and safer than open surgical methods. OBJECTIVE: To compare open surgical circumcision with suturing v. the Unicirc disposable instrument plus tissue adhesive. METHODS: We conducted a non-blinded randomised controlled trial at an outpatient primary healthcare clinic in Cape Town, South Africa, with 2:1 allocation ratio of 150 male volunteers who were at least 18 years of age. Our primary outcome was intraoperative time and secondary outcomes were ease of performance, post-operative pain, adverse events, time to healing, patient satisfaction and cosmetic result.