Safety of a disposable male circumcision kit. results from a randomized controlled trial conducted in South Africa

Objective: Properly sterilized instruments and appropriate consumables are needed to perform male circumcision procedures in safe conditions. In response to this need a South African company recently prepared a single-use sterilized toolkit (Cir-Kit) containing all disposable instruments, consumables and pharmaceutical products needed to perform one single male circumcision among young male adults according to the most common technique used in South Africa (the Forceps Guided technique). The objective of this study was to evaluate the safety of this new circumcision kit. Patients and Methods: Following on from a randomized controlled trial on the impact of male circumcision on HIV transmission, 511 of 3274 participants agreed to take part in a trial on male circumcision methods. They were circumcised by one of the three general practitioners already performing the circumcisions in the main trial on the impact of circumcision, using the Forceps Guided method. The patients were randomized into two groups of equal size (using the Cir-Kit (CK group), or using conventional reusable instruments (RI group)). Adverse events were recorded by the general practitioners in charge of the follow-up to surgery, and the participants attended a check-up visit 6 weeks after surgery, during which they underwent a clinical examination performed by a nurse and answered a standardized questionnaire, including the assessment of pain using a visual pain analogue scale. Results: Of the 513 men invited to participate, 511 consented and 259 were randomized to the RI group and 252 to the CK group. Eighty per cent of those circumcised by the RI method and 85% of those circumcised by the CK method attended the post-circumcision visit, as reported by the nurse from genital examination performed during the post-circumcision visit or reported by participants to the nurse. No statistically significant difference in complication rates was found between the two groups (with type I error risk of 5%). All equivalence tests were significant when lower and upper bounds for difference were taken at D=±10% (±20 mm for mean pain score). With D=±5% (±10 mm for mean pain score), 7 out of 13 equivalence tests remained significant. Conclusion: The male circumcision Cir-Kit toolkit was found to be equivalent to re-usable conventional instruments as used in optimal safety conditions. This product will be useful when used in settings where sterilization of reusable instruments is not easy or where consumables and pharmaceutical products are scarce. Practitioners' training, proper follow-up of the patients and access to medical facilities in case of serious complications are, however, also required. Fond et objectif : Les instruments correctement stérilisés et les consommables appropriés sont nécessaires pour exécuter les procédures de circoncision dans des conditions de sécurité sanitaire satisfaisante. En réponse à ce besoin une compagnie sud-africaine a récemment préparé une trousse à usage un