Early infant male circumcision using devices

Authors
Category Primary study
Registry of TrialsPan African Clinical Trials Registry
Year 2012
INTERVENTION: Circumcision using AccuCirc Circumcision using Mogen clamp CONDITION: ; HIV/AIDS ; Surgery ; Urological and Genital Diseases ; Paediatrics ; Early infant circumcision ultimately for HIV prevention Early infant circumcision ultimately for HIV prevention HIV/AIDS Paediatrics Surgery Urological and Genital Diseases PRIMARY OUTCOME: ¿ Acceptability ‐ The proportion of parents who report being satisfied with the procedure by EIMC technique ¿ Cost ‐ Monetary cost of equipment usage for each technique plus training costs and labour cost associated with EIMC under each technique and the cost of AE under each technique ¿ Safety ‐ Number of AEs (minor, moderate and severe) related to each EIMC technique SECONDARY OUTCOME: ¿ Assessment of competency of EIMC using each device ¿ Proportion of babies excluded due to unsuitability for circumcision ¿ Proportion with complete wound healing at 7 and 14 days post circumcision for each EIMC technique ¿ Safety stratified by infant HIV exposure status ¿ Time required for each EIMC technique Provider opinions of each device INCLUSION CRITERIA: Live born male infants at study sites aged 7‐10 days. Ability to follow‐up regularly at study clinic until 2 weeks postpartum Mother prepared to provide locator information and to be visited home between delivery and circumcision Mother prepared to provide verifiable cell phone (mobile) number Provision of written informed consent Baby should have received vitamin K (routine or offered by study staff)
Epistemonikos ID: 799c21d37c4a7cc2d7357f5de961b404051efe39
First added on: Aug 22, 2024