A new Male Circumcision (MC) device, PrePex, has shown great promise as a way to radically shift the MC landscape. PrePex is an innovative circumcision device requiring no injected anesthesia, sutures, or sterile settings. Moreover, it is designed for use by minimally skilled healthcare professionals rather than surgeons. Two initial studies conducted in Rwanda in 2010 and 2011 demonstrated an excellent safety profile when the procedure was performed by skilled physicians
Rwanda Has also completed a third study to assess the safety and efficacy of MC when performed by nurses using PrePex in both rural and urban hospitals, Device safety was assessed by the rate of clinical adverse events and device-related incidents attributed to the PrePex device and its procedures, the study report was shared with the WHO Male Circumcision Technical Advisory Group. On February 2011 the WHO provided Rwanda with recommendation to phase in MC scale up with the PrePex device on adults. Moreover the WHO recommended Rwanda to study the PrePex for use on adolescent population, starting on ages 15-17 and thereafter on ages 12-14 and 10-12.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
300
The PrePex device is designed to enable conducting male circumcision procedure that is bloodless with no anesthesia and no sutures. For contraindicated subjects, a preparation procedure will take place.
Rwanda Military Hospital
Kigali, Kigali, Rwanda
Incidence of Serious Adverse Events on adolescent male population including contraindicated subjects in ages 10 to 17
Time frame: up to 7 weeks
Glans fully exposed
Time frame: Up to 7 weeks
The pain at key time points
Time frame: Up to 7 weeks
Time to complete healing
Time frame: Up to 7 weeks
Time to numb the foreskin using topical Lidocaine 5% cream - for contraindicated subjects only
Time frame: Up to 7 weeks
Rate of side effects
Time frame: Up to 7 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.