TY - JOUR
T1 - The safety and acceptance of the PrePex device for non-surgical adult male circumcision in Rakai, Uganda. A non-randomized observational study
AU - Kigozi, Godfrey
AU - Musoke, Richard
AU - Watya, Stephen
AU - Kighoma, Nehemia
AU - Nkale, James
AU - Nakafeero, Mary
AU - Namuguzi, Dan
AU - Serwada, David
AU - Nalugoda, Fred
AU - Sewankambo, Nelson
AU - Wawer, Maria Joan
AU - Gray, Ronald Henry
N1 - Funding Information:
This study was supported by grant UO1 AI075115-0451 from the Division of AIDS (DAIDS) of the US National Institutes of Health (NIH). We acknowledge the assistance of the Rwandan Training team (Dr.Ngeruka M. Leon, Dr.Sibomana Alphouse, Amuhinde Jacpus and Lior Levert) and Margaret Nagujja from IHK and express our gratitude to the study participants and Rakai Health Sciences Program staff.
PY - 2014/8/21
Y1 - 2014/8/21
N2 - Objectives: To assess the safety and acceptance of the PrePex device for medical male circumcision (MMC) in rural Uganda. Methods: 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. Results: 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). Conclusion: 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.
AB - Objectives: To assess the safety and acceptance of the PrePex device for medical male circumcision (MMC) in rural Uganda. Methods: 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. Results: 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). Conclusion: 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.
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U2 - 10.1371/journal.pone.0100008
DO - 10.1371/journal.pone.0100008
M3 - Article
C2 - 25144194
AN - SCOPUS:84929056271
SN - 1932-6203
VL - 9
JO - PloS one
JF - PloS one
IS - 8
M1 - e100008
ER -