Research

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

Peter S Millard, Hannah R Wilson, Norman D Goldstuck, Chibuzo Anaso

Abstract


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.

Results. The intraoperative time was less with the Unicirc/adhesive technique (median 13 v. 22.6 min, respectively; p<0.001). The intraoperative suturing rate was 17% using the Unicirc device. Other adverse events and wound healing outcomes were similar in both groups, but the cosmetic result was superior in the Unicirc group. Doctors found the Unicirc procedure easier to perform and preferred it to the open surgical technique.

Conclusions. This study has important implications for the scale-up of VMMC services. Excising the foreskin with the Unicirc instrument and sealing the wound with cyanoacrylate tissue adhesive in adults is quicker, easier to learn, and is potentially safer than open surgical VMMC. Further studies should be conducted with the optimised device. This new instrument has the potential to facilitate more rapid scale-up and save costs. 


Authors' affiliations

Peter S Millard, Graduate Program in Public Health, University of New England, Portland, Maine, USA

Hannah R Wilson, Department of Pediatrics, New York University, New York, USA

Norman D Goldstuck, Department of Obstetrics and Gynaecology, Faculty of Medicine and Health Sciences, Stellenbosch University and Tygerberg Hospital, Cape Town, South Africa

Chibuzo Anaso, Simunye Primary Health Care, Mitchells Plain, Western Cape, South Africa

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Keywords

circumcision; HIV prevention

Cite this article

South African Medical Journal 2014;104(1):52-57. DOI:10.7196/SAMJ.7357

Article History

Date submitted: 2013-08-09
Date published: 2013-11-20

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