High rate of adverse events following circumcision of young male adults with the Tara KLamp technique: A randomized trial in South Africa.

Abstract

Background: The Tara KLamp invention has been claimed to enable circumcisions to be performed safely and easily in many environments. Published evaluation studies were conducted among young children only.

Methods: Following a randomized controlled trial (MCRCT) in 3274 participants on the impact of male circumcision on HIV transmission, 69 control group members participated in this male circumcision methods trial (MCMT) and were randomized to a Forceps Guided (FG) group and a Tara KLamp (TK) group) and circumcised.

Results: Of the 166 men asked to participate 97 declined, most (94) refusing circumcision with the Tara KLamp technique; 34 men were randomized to the FG group and 35 to the TK group, and 32 and 24 patients were circumcised with the FG and TK methods respectively, of whom respectively 91% and 79% attended the post-circumcision visit.
All 12 adverse event sheets corresponded to the TK group (p<0.001) and circumcised with the TK method. Less favourable outcomes were associated with the TK method, including any sign of an adverse event (37% vs. 3%; p=0.004), delayed wound healing (21% vs. 3%; p=0.004) and problem with penis appearance (31% vs. 3%; p=0.001).
Participants randomized to the TK method were significantly more likely to report bleeding (21% vs. 0%; p=0.02), damage to the penis (21% vs. 0%; p=0.02), infection (32% vs. 0%; p=0.002), swelling (83% vs. 0%; p<10-3), and problem with urinating (16% vs. 0%; p=0.056). The mean score of self-estimated pain was 9.5 for participants circumcised with TK as compared to 6.1 for other participants (adjusted p=0.003).

Conclusion: This study provides compelling evidence to strongly caution against the use of the Tara KLamp method among young adults.