The Safety and Acceptance of the PrePex Device for Non- Surgical Adult Male Circumcision in Rakai, Uganda. A Non-Randomized Observational Study

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dc.contributor.authorKigozi, Godfrey
dc.contributor.authorMusoke, Richard
dc.contributor.authorWatya, Stephen
dc.contributor.authorKighoma, Nehemia
dc.contributor.authorNkale, James
dc.contributor.authorNakafeero, Mary
dc.contributor.authorNamuguzi, Dan
dc.contributor.authorSerwada, David
dc.contributor.authorNalugoda, Fred
dc.contributor.authorSewankambo, Nelson
dc.contributor.authorWawer, Maria Joan
dc.contributor.authorGray, Ronald Henry
dc.date.accessioned2022-06-14T12:20:31Z
dc.date.available2022-06-14T12:20:31Z
dc.date.issued2014
dc.description.abstractTo assess the safety and acceptance of the PrePex device for medical male circumcision (MMC) in rural Uganda.In an observational study, HIV-uninfected, uncircumcised men aged 18 and older who requested elective MMC were informed about the PrePex and dorsal slit methods and offered a free choice of their preferred procedure. 100 men received PrePex to assess preliminary safety (aim 1). An additional 329 men, 250 chose PrePex and 79 chose Dorsal slit, were enrolled following approval by the Safety Monitoring Committee (aim 2). Men were followed up at 7 days to assess adverse events (AEs) and to remove the PrePex device. Wound healing was assessed at 4 weeks, with subsequent weekly follow up until completed healing.The PrePex device was contraindicated in 5.7% of men due to a tight prepuce or phimosis/adhesions. Among 429 enrolled men 350 (82.0%) got the PrePex device and 79 (18.0%) the dorsal slit procedure. 250 of 329 men (76.0%) who were invited to choose between the 2 procedures chose Prepex. There were 9 AEs (2.6%) with the PrePex, of which 5 (1.4%) were severe complications, 4 due to patient self-removal of the device leading to edema and urinary obstruction requiring emergency surgical circumcision, and one due to wound dehiscence following device removal. 71.8% of men reported an unpleasant odor prior to PrePex removal. Cumulative rates of completed wound healing with the PrePex were 56.7% at week 4, 84.8% week 5, 97.6% week 6 and 98.6% week 7, compared to 98.7% at week 4 with dorsal slit (p<0.0001).The PrePex device was well accepted, but healing was slower than with dorsal slit surgery. Severe complications, primarily following PrePex self-removal, required rapid access to emergency surgical facilities. The need to return for removal and delayed healing may increase Program cost and client burden.en_US
dc.identifier.citationKigozi, G., Musoke, R., Watya, S., Kighoma, N., Nkale, J., Nakafeero, M., ... & Gray, R. H. (2014). The safety and acceptance of the PrePex device for non-surgical adult male circumcision in Rakai, Uganda. A non-randomized observational study. PloS one, 9(8), e100008.https://doi.org/10.1371/journal.pone.0100008en_US
dc.identifier.urihttps://nru.uncst.go.ug/handle/123456789/3958
dc.language.isoenen_US
dc.publisherPloS oneen_US
dc.titleThe Safety and Acceptance of the PrePex Device for Non- Surgical Adult Male Circumcision in Rakai, Uganda. A Non-Randomized Observational Studyen_US
dc.typeArticleen_US
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