| dc.description.abstract | To assess healing with Shang Ring removal at
different prespecified times; whether spontaneous detachment occurs
with delayed removal; problems, complaints, and acceptability of
wearing the device; satisfaction among participants; and acceptability
of the procedure among providers.
Methods: Fifty HIV-negative men underwent a Shang Ring circumcision
in Kenya. Men were randomly assigned for device
removal at 7 (15 men), 14 (15 men), or 21 days (20 men). Followup
visits were at 7, 14, 21, 28, and 42 days after circumcision and
2 days after removal.
Results: Circumcision and device removal were conducted without
significant problems. Mean times for circumcision and device removal
were 6.5(SD = 2.4) and2.5(SD = 0.8) minutes, respectively. Complete
detachment of the device occurred in 22 (66.7%) men who wore it
more than 7 days. Seven men (14.0%) with partial detachments
requested removal 8–14 days post circumcision due to pain/discomfort.
Healing progressed normally in all participants;cumulative probabilities of complete healing were similar across groups. No severe or serious
adverse events occurred. Acceptability among participants was high.
Providers reported that Shang Ring circumcision was“very easy” compared
with the forceps-guided procedure.
Conclusion: The Shang Ring is safe and easy to use according to
label instructions (7 day removal). Detachments occurred without
significant problems, although some men requested removal of partially
detached rings. Removal time had little effect on healing. These
data help allay concerns about men not returning for ring removal and
expand the evidence base suggesting the Shang Ring could facilitate
rapid male circumcision rollout in sub-Saharan Africa. | en_US |
