A proof of concept study to evaluate the feasibility of using the Shang Ring, a novel male circumcision device across all childhood age groups namely infants (under 1), 1-5 age group, 6-12 age group and the 13-17 age group. The study will evaluate the safety, efficacy and course of wound healing when using the Shang Ring technique across the four childhood age groups.
A proof of concept study to evaluate the feasibility of using the Shang Ring, a novel male circumcision device across all childhood age groups namely infants (under 1), 1-5 age group, 6-12 age group and the 13-17 age group. The study will evaluate efficacy, procedure time, difficulties during surgery and post-operative events shall be assessed. To evaluate safety, the investigators will clinically observe for adverse events during the course of healing. The investigators will also evaluate to length of time taken for complete healing to be achieved.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
80
Homa Bay District Hospital
Homa Bay, Kenya
To evaluate safety when using the Shang Ring technique across the 4 age groups ranging from infants to adolescents.
Documentation of adverse events based on clinical exam findings
Time frame: 42 days after circumcision
To evaluate efficacy when using the Shang Ring technique across the 4 age groups ranging from infants to adolescents.
To evaluate efficacy, procedure time, peri- and postoperative surgical complications, and problems with use of the device will be assessed.
Time frame: 42 days after circumcision
To evaluate the course of wound healing when using the Shang Ring technique across the 4 age groups ranging from infants to adolescents.
Evaluation of the course of healing and length of time required for complete healing will be based on clinical exam findings.
Time frame: 42 days after circumcision
To determine the acceptability of the Shang Ring device by the participants (or their parents)
Clients and/or parents shall be interviewed on their experience with the Shang Ring during their participation in the study.
Time frame: 42 days after circumcison
To evaluate the ease of use of the Shang Ring technique across the 4 age groups ranging from infants to adolescents
To evaluate the ease of use of the Shang Ring device, clinicians shall be interviewed on the difficulties they faced with using the device and their perception about use of the device relative to conventional surgical approaches
Time frame: 42 days after circumcision
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