title: The safety and acceptance of the PrePex device for non-surgical adult male circumcision in Rakai, Uganda. A non-randomized observational study.
abstract: OBJECTIVE
  To assess the safety and acceptance of the PrePex device for medical male circumcision (MMC) in rural Uganda.
  
  
  METHODS
  In an observational study, HIV-uninfected, uncircumcised men aged 18 and older who requested elective MMC were informed about the PrePex and dorsal slit methods and offered a free choice of their preferred procedure. 100 men received PrePex to assess preliminary safety (aim 1). An additional 329 men, 250 chose PrePex and 79 chose Dorsal slit, were enrolled following approval by the Safety Monitoring Committee (aim 2). Men were followed up at 7 days to assess adverse events (AEs) and to remove the PrePex device. Wound healing was assessed at 4 weeks, with subsequent weekly follow up until completed healing.
  
  
  RESULTS
  The PrePex device was contraindicated in 5.7% of men due to a tight prepuce or phimosis/adhesions. Among 429 enrolled men 350 (82.0%) got the PrePex device and 79 (18.0%) the dorsal slit procedure. 250 of 329 men (76.0%) who were invited to choose between the 2 procedures chose Prepex. There were 9 AEs (2.6%) with the PrePex, of which 5 (1.4%) were severe complications, 4 due to patient self-removal of the device leading to edema and urinary obstruction requiring emergency surgical circumcision, and one due to wound dehiscence following device removal. 71.8% of men reported an unpleasant odor prior to PrePex removal. Cumulative rates of completed wound healing with the PrePex were 56.7% at week 4, 84.8% week 5, 97.6% week 6 and 98.6% week 7, compared to 98.7% at week 4 with dorsal slit (p<0.0001).
  
  
  CONCLUSIONS
  The PrePex device was well accepted, but healing was slower than with dorsal slit surgery. Severe complications, primarily following PrePex self-removal, required rapid access to emergency surgical facilities. The need to return for removal and delayed healing may increase Program cost and client burden.
authors.affiliation: Rakai Health Sciences Program, Entebbe, Uganda.
authors.forename: Godfrey
authors.initials: G
authors.lastname: Kigozi
authors.affiliation: Rakai Health Sciences Program, Entebbe, Uganda.
authors.forename: Richard
authors.initials: R
authors.lastname: Musoke
authors.affiliation: Rakai Health Sciences Program, Entebbe, Uganda.
authors.forename: Stephen
authors.initials: S
authors.lastname: Watya
authors.affiliation: Rakai Health Sciences Program, Entebbe, Uganda.
authors.forename: Nehemia
authors.initials: N
authors.lastname: Kighoma
authors.affiliation: Rakai Health Sciences Program, Entebbe, Uganda.
authors.forename: James
authors.initials: J
authors.lastname: Nkale
authors.affiliation: Rakai Health Sciences Program, Entebbe, Uganda.
authors.forename: Mary
authors.initials: M
authors.lastname: Nakafeero
authors.affiliation: Department of Urology, Mulago Hospital, Kampala, Uganda.
authors.forename: Dan
authors.initials: D
authors.lastname: Namuguzi
authors.affiliation: Rakai Health Sciences Program, Entebbe, Uganda; School of Public Health, Makerere University College of Health Sciences, Kampala, Uganda.
authors.forename: David
authors.initials: D
authors.lastname: Serwada
authors.affiliation: Rakai Health Sciences Program, Entebbe, Uganda.
authors.forename: Fred
authors.initials: F
authors.lastname: Nalugoda
authors.affiliation: Rakai Health Sciences Program, Entebbe, Uganda; College of Health Sciences, Makerere University, Kampala, Uganda.
authors.forename: Nelson
authors.initials: N
authors.lastname: Sewankambo
authors.affiliation: Rakai Health Sciences Program, Entebbe, Uganda; Department of Epidemiology, Johns Hopkins University, Bloomberg School of Public Health, Baltimore, Maryland, United States of America.
authors.forename: Maria Joan
authors.initials: MJ
authors.lastname: Wawer
authors.affiliation: Rakai Health Sciences Program, Entebbe, Uganda; Department of Epidemiology, Johns Hopkins University, Bloomberg School of Public Health, Baltimore, Maryland, United States of America.
authors.forename: Ronald Henry
authors.initials: RH
authors.lastname: Gray
mesh_terms: D000293:Adolescent; D000328:Adult; D002944:Circumcision, Male / Q000009:adverse effects / Q000295:instrumentation* / Q000592:standards; D006801:Humans; D008297:Male; D064887:Observational Studies as Topic; D014454:Uganda; D014945:Wound Healing / Q000502:physiology; D055815:Young Adult