title: The safety profile and acceptability of a disposable male circumcision device in Kenyan men undergoing voluntary medical male circumcision.
abstract: OBJECTIVE
  We established the safety and effectiveness as well as the acceptability of the Alisklamp® device for male circumcision among Kenyan men.
  
  
  METHODS
  To qualify for this hospital based, prospective, interventional cohort study one needed to be an uncircumcised adult male who was HIV negative with no comorbid factors or genitourinary anomalies precluding circumcision. A total of 58 men were recruited from a population of 90. Outcome measures were the safety profile of Alisklamp and its efficiency and acceptability by participants.
  
  
  RESULTS
  All 58 procedures were completed without device malfunction, hemorrhage or undesirable preputial excision. Mean ± SD procedure time was 2.43 ± 1.36 minutes and mean device removal time was 15.8 ± 7.4 seconds. There were 2 adverse events, including mild edema and superficial wound infection related to poor hygiene in 1 case each. All men resumed routine activity immediately after circumcision. Of the 58 participants 25.9% experienced mild nocturnal erectile pains that required no medication. During 6-week followup all men were satisfied with the procedure, tolerated the device well and would recommend it to a friend.
  
  
  CONCLUSIONS
  Alisklamp has an excellent safety profile and excellent acceptability among men who undergo circumcision using the device. This technique is easy to teach and it would prove to be a handy device to scale up the rate of male circumcision. Based on these findings the device merits a comparative clinical trial.
authors.affiliation: Department of Surgery and Anaesthesiology, School of Medicine, Moi University, Eldoret, Kenya. musau_pius@yahoo.com
authors.forename: Pius
authors.initials: P
authors.lastname: Musau
authors.forename: Mustafa
authors.initials: M
authors.lastname: Demirelli
authors.forename: Nicholas
authors.initials: N
authors.lastname: Muraguri
authors.forename: Francis
authors.initials: F
authors.lastname: Ndwiga
authors.forename: Daniel
authors.initials: D
authors.lastname: Wainaina
authors.forename: Nabila Amin
authors.initials: NA
authors.lastname: Ali
mesh_terms: D000293:Adolescent; D000328:Adult; D002944:Circumcision, Male / Q000295:instrumentation* / Q000379:methods; D020878:Device Removal; D004867:Equipment Design; D006801:Humans; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D016896:Treatment Outcome; D055815:Young Adult