PURPOSE: We established the safety and effectiveness as well as the acceptability of the Alisklamp® device for male circumcision among Kenyan men. MATERIALS AND 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.
PURPOSE: We established the safety and effectiveness as well as the acceptability of the Alisklamp® device for male circumcision among Kenyan men. MATERIALS AND 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: Larissa Jennings; Jane Bertrand; Dino Rech; Steven A Harvey; Karin Hatzold; Christopher A Samkange; Dickens S Omondi Aduda; Bennett Fimbo; Peter Cherutich; Linnea Perry; Delivette Castor; Emmanuel Njeuhmeli Journal: PLoS One Date: 2014-05-06 Impact factor: 3.240