PMID- 25144194
OWN - NLM
STAT- MEDLINE
DCOM- 20150511
LR  - 20211021
IS  - 1932-6203 (Electronic)
IS  - 1932-6203 (Linking)
VI  - 9
IP  - 8
DP  - 2014
TI  - The safety and acceptance of the PrePex device for non-surgical adult male 
      circumcision in Rakai, Uganda. A non-randomized observational study.
PG  - e100008
LID - 10.1371/journal.pone.0100008 [doi]
LID - e100008
AB  - OBJECTIVES: 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). CONCLUSION: 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.
FAU - Kigozi, Godfrey
AU  - Kigozi G
AD  - Rakai Health Sciences Program, Entebbe, Uganda.
FAU - Musoke, Richard
AU  - Musoke R
AD  - Rakai Health Sciences Program, Entebbe, Uganda.
FAU - Watya, Stephen
AU  - Watya S
AD  - Rakai Health Sciences Program, Entebbe, Uganda.
FAU - Kighoma, Nehemia
AU  - Kighoma N
AD  - Rakai Health Sciences Program, Entebbe, Uganda.
FAU - Nkale, James
AU  - Nkale J
AD  - Rakai Health Sciences Program, Entebbe, Uganda.
FAU - Nakafeero, Mary
AU  - Nakafeero M
AD  - Rakai Health Sciences Program, Entebbe, Uganda.
FAU - Namuguzi, Dan
AU  - Namuguzi D
AD  - Department of Urology, Mulago Hospital, Kampala, Uganda.
FAU - Serwada, David
AU  - Serwada D
AD  - Rakai Health Sciences Program, Entebbe, Uganda; School of Public Health, Makerere 
      University College of Health Sciences, Kampala, Uganda.
FAU - Nalugoda, Fred
AU  - Nalugoda F
AD  - Rakai Health Sciences Program, Entebbe, Uganda.
FAU - Sewankambo, Nelson
AU  - Sewankambo N
AD  - Rakai Health Sciences Program, Entebbe, Uganda; College of Health Sciences, 
      Makerere University, Kampala, Uganda.
FAU - Wawer, Maria Joan
AU  - Wawer MJ
AD  - Rakai Health Sciences Program, Entebbe, Uganda; Department of Epidemiology, Johns 
      Hopkins University, Bloomberg School of Public Health, Baltimore, Maryland, 
      United States of America.
FAU - Gray, Ronald Henry
AU  - Gray RH
AD  - Rakai Health Sciences Program, Entebbe, Uganda; Department of Epidemiology, Johns 
      Hopkins University, Bloomberg School of Public Health, Baltimore, Maryland, 
      United States of America.
LA  - eng
GR  - U01 AI075115-0451/AI/NIAID NIH HHS/United States
PT  - Journal Article
PT  - Research Support, N.I.H., Extramural
DEP - 20140821
PL  - United States
TA  - PLoS One
JT  - PloS one
JID - 101285081
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Circumcision, Male/adverse effects/*instrumentation/standards
MH  - Humans
MH  - Male
MH  - Observational Studies as Topic
MH  - Uganda
MH  - Wound Healing/physiology
MH  - Young Adult
PMC - PMC4140666
COIS- Competing Interests: Ronald H. Gray is a member of the PLOS ONE editorial board. 
      This does not alter the authors' adherence to PLOS ONE Editorial policies and 
      criteria.
EDAT- 2014/08/22 06:00
MHDA- 2015/05/12 06:00
PMCR- 2014/08/21
CRDT- 2014/08/22 06:00
PHST- 2014/01/14 00:00 [received]
PHST- 2014/05/21 00:00 [accepted]
PHST- 2014/08/22 06:00 [entrez]
PHST- 2014/08/22 06:00 [pubmed]
PHST- 2015/05/12 06:00 [medline]
PHST- 2014/08/21 00:00 [pmc-release]
AID - PONE-D-13-51115 [pii]
AID - 10.1371/journal.pone.0100008 [doi]
PST - epublish
SO  - PLoS One. 2014 Aug 21;9(8):e100008. doi: 10.1371/journal.pone.0100008. 
      eCollection 2014.