PMID- 24788898
OWN - NLM
STAT- MEDLINE
DCOM- 20141218
LR  - 20211021
IS  - 1932-6203 (Electronic)
IS  - 1932-6203 (Linking)
VI  - 9
IP  - 5
DP  - 2014
TI  - Safety, effectiveness and acceptability of the PrePex device for adult male 
      circumcision in Kenya.
PG  - e95357
LID - 10.1371/journal.pone.0095357 [doi]
LID - e95357
AB  - OBJECTIVE: To assess the safety, effectiveness and acceptability of the PrePex 
      device for adult medical male circumcision (MMC) in routine service delivery in 
      Kenya. METHODS: We enrolled 427 men ages 18-49 at one fixed and two outreach 
      clinics. Procedures were performed by trained clinical officers and nurses. The 
      first 50 enrollees were scheduled for six follow-up visits, and remaining men 
      were followed at Days 7 and 42. We recorded adverse events (AEs) and time to 
      complete healing, and interviewed men about acceptability and pain. RESULTS: 
      Placement and removal procedures each averaged between 3 and 4 minutes. 
      Self-reported pain was minimal during placement but was fleetingly intense during 
      removal. The rate of moderate/severe AEs was 5.9% overall (95% confidence 
      interval [CI] 3.8%-8.5%), all of which resolved without sequelae. AEs included 5 
      device displacements, 2 spontaneous foreskin detachments, and 9 cases of 
      insufficient foreskin removal. Surgical completion of MMC was required for 9 men 
      (2.1%). Among the closely monitored first 50 participants, the probability of 
      complete healing by Day 42 was 0.44 (95% CI 0.30-0.58), and 0.90 by Day 56. A 
      large majority of men was favorable about their MMC procedure and would recommend 
      PrePex to friends and family. CONCLUSIONS: The PrePex device was effective for 
      MMC in Kenya, and well-accepted. The AE rate was higher than reported for 
      surgical procedures there, or in previous PrePex studies. Healing time is longer 
      than following surgical circumcision. Provider experience and clearer counseling 
      on post-placement and post-removal care should lead to lower AE rates. TRIAL 
      REGISTRATION: ClinicalTrials.gov NCT01711411.
FAU - Feldblum, Paul J
AU  - Feldblum PJ
AD  - Clinical Sciences Unit, FHI 360, Durham, North Carolina, United States of 
      America.
FAU - Odoyo-June, Elijah
AU  - Odoyo-June E
AD  - Nyanza Reproductive Health Society, Kisumu, Kenya; Centers for Disease Control 
      and Prevention/Kenya, Nairobi, Kenya.
FAU - Obiero, Walter
AU  - Obiero W
AD  - Nyanza Reproductive Health Society, Kisumu, Kenya; University of Illinois at 
      Chicago, Chicago, Illinois, United States of America.
FAU - Bailey, Robert C
AU  - Bailey RC
AD  - University of Illinois at Chicago, Chicago, Illinois, United States of America.
FAU - Combes, Stephanie
AU  - Combes S
AD  - Clinical Sciences Unit, FHI 360, Durham, North Carolina, United States of 
      America.
FAU - Hart, Catherine
AU  - Hart C
AD  - Clinical Sciences Unit, FHI 360, Durham, North Carolina, United States of 
      America.
FAU - Jou Lai, Jaim
AU  - Jou Lai J
AD  - Quantitative Sciences Department, FHI 360, Durham, North Carolina, United States 
      of America.
FAU - Fischer, Shelly
AU  - Fischer S
AD  - Clinical Sciences Unit, FHI 360, Durham, North Carolina, United States of 
      America.
FAU - Cherutich, Peter
AU  - Cherutich P
AD  - National AIDS & STI Control Programme, Nairobi, Kenya.
LA  - eng
SI  - ClinicalTrials.gov/NCT01711411
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20140501
PL  - United States
TA  - PLoS One
JT  - PloS one
JID - 101285081
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Circumcision, Male/adverse effects/*instrumentation/*methods
MH  - Humans
MH  - Kenya
MH  - Male
MH  - Middle Aged
MH  - Pain Measurement
MH  - *Patient Acceptance of Health Care
MH  - Self Report
MH  - Treatment Outcome
MH  - Wound Healing
MH  - Young Adult
PMC - PMC4006910
COIS- Competing Interests: The authors have declared that no competing interests exist.
EDAT- 2014/05/03 06:00
MHDA- 2014/12/19 06:00
PMCR- 2014/05/01
CRDT- 2014/05/03 06:00
PHST- 2014/01/15 00:00 [received]
PHST- 2014/03/25 00:00 [accepted]
PHST- 2014/05/03 06:00 [entrez]
PHST- 2014/05/03 06:00 [pubmed]
PHST- 2014/12/19 06:00 [medline]
PHST- 2014/05/01 00:00 [pmc-release]
AID - PONE-D-14-02000 [pii]
AID - 10.1371/journal.pone.0095357 [doi]
PST - epublish
SO  - PLoS One. 2014 May 1;9(5):e95357. doi: 10.1371/journal.pone.0095357. eCollection 
      2014.