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.
RCT Entities:
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: Brian Matovu; Mercy Takuwa; Charles Norman Mpaata; Fiona Denison; Noah Kiwanuka; Steff Lewis; John Norrie; Sam Ononge; Owen Muhimbise; Sharon Tuck; Maureen Dimitri Etuket; Robert T Ssekitoleko Journal: Front Med Technol Date: 2022-07-28