The Safety Profile and Acceptability of a Disposable Male Circumcision Device in Kenyan Men Undergoing Voluntary Medical Male Circumcision

Purpose: We established the safety and effectiveness as well as the acceptability of the Alisklamp(R) 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.