No-needle, single-visit adult male circumcision with Unicirc: a multi-centre field trial

PLoS One. 2015 Mar 30;10(3):e0121686. doi: 10.1371/journal.pone.0121686. eCollection 2015.

Abstract

Background: Voluntary medical male circumcision (VMMC) is a priority HIV preventive intervention. Current adult circumcision methods need improvement.

Methods: Field trial in 3 primary care centres. Minimally invasive VMMC using the Unicirc instrument following topical lidocaine/prilocaine anesthetic. Men were followed up at 1 and 4 weeks.

Results: We circumcised 110 healthy volunteers. Two men complained of transient burning pain during circumcision, but none required injectable anaesthesia. Median blood loss was 1ml and median procedure time was 9.0 min. There were 7 (6.3%) moderate complications (5 (4.5%) post-operative bleeds requiring suture and 2 (1.8%) post-operative infections) affecting 7 men. No men experienced significant wound dehiscence. 90.4% of men were fully healed at 4 weeks of follow-up and all were highly satisfied.

Conclusions: Use of topical anaesthesia obviates the need for injectable anesthetic and makes the Unicirc procedure nearly painless. Unicirc is rapid, easy to learn, heals by primary intention with excellent cosmetic results, obviates the need for a return visit for device removal, and is potentially cheaper and safer than other methods. Use of this method will greatly facilitate scale-up of mass circumcision programs.

Trial registration: ClinicalTrials.gov NCT02091726.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Anesthetics, Local / administration & dosage
  • Circumcision, Male / adverse effects
  • Circumcision, Male / instrumentation*
  • Circumcision, Male / methods
  • HIV Infections / prevention & control
  • HIV Infections / transmission
  • Humans
  • Male
  • Minimally Invasive Surgical Procedures / adverse effects
  • Minimally Invasive Surgical Procedures / instrumentation
  • Minimally Invasive Surgical Procedures / methods
  • Postoperative Hemorrhage / etiology
  • South Africa
  • Surgical Wound Infection / etiology
  • Time Factors
  • Tissue Adhesives / administration & dosage
  • Wound Healing
  • Young Adult

Substances

  • Anesthetics, Local
  • Tissue Adhesives

Associated data

  • ClinicalTrials.gov/NCT02091726

Grants and funding

This study was supported by Simunye Primary Health Care. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.