PMID- 29566320 OWN - NLM STAT- MEDLINE DCOM- 20190128 LR - 20191113 IS - 1118-4841 (Print) IS - 1118-4841 (Linking) VI - 20 IP - 4 DP - 2016 Dec TI - Prospective Observational Study of the ShangRing Device for Adult Medical Male Circumcision in a Routine Clinical Setting in Malawi. PG - 60-66 AB - We evaluated the safety and acceptability of the ShangRing device for male circumcision during routine clinical service delivery in Namitete, Malawi. We conducted a prospective observational study enrolling 500 HIV-negative men ages 18 to 49 years at St. Gabriel's Hospital. Participants returned for two follow-up visits: the removal visit (day 7 after placement) and the healing check visit (day 42 after placement). We assessed pain, adverse events (AEs), acceptability, and healing. 500 men were screened; 498 were circumcised using the ShangRing and comprised the analysis population. Seven participants (1.4%) experienced moderate AEs related to circumcision. 93% were judged to be completely healed at or before the day 42 visit; 6% were judged to be healed later than the day 42 visit; 5 participants (1.0%) were lost to follow-up. 98% of men stated they were very satisfied with the appearance of their circumcised penis, and 99.6% would recommend ShangRing circumcision to family/friends. Adult male circumcision using the ShangRing was safe with a low AE rate at this service delivery site. Acceptability factors were also favorable. Addition of the ShangRing device could be beneficial to achieving the goals of the circumcision program in Malawi. FAU - Feldblum, Paul J AU - Feldblum PJ AD - FHI 360, Durham, North Carolina, USA. FAU - Mwambula, Chikondi AU - Mwambula C AD - St. Gabriel's Hospital, Namitete, Malawi. FAU - Selemani, Monija AU - Selemani M AD - St. Gabriel's Hospital, Namitete, Malawi. FAU - Long, Sarah AU - Long S AD - FHI 360, Durham, North Carolina, USA. FAU - Telela, Dyson James AU - Telela DJ AD - Christian Health Association of Malawi (CHAM), Lilongwe, Malawi. FAU - Mwenyekonde, Elled AU - Mwenyekonde E AD - Christian Health Association of Malawi (CHAM), Lilongwe, Malawi. FAU - Lai, Jaim Jou AU - Lai JJ AD - FHI 360, Durham, North Carolina, USA. FAU - Veena, Valentine AU - Veena V AD - FHI 360, Nairobi, Kenya. FAU - Mbeya, Phyela AU - Mbeya P AD - St. Gabriel's Hospital, Namitete, Malawi. LA - eng PT - Journal Article PT - Observational Study PL - Nigeria TA - Afr J Reprod Health JT - African journal of reproductive health JID - 9712263 SB - IM MH - Adolescent MH - Adult MH - Circumcision, Male/adverse effects/*instrumentation/statistics & numerical data MH - *Equipment and Supplies/adverse effects/standards MH - *Hospitals/statistics & numerical data MH - Humans MH - Malawi/epidemiology MH - Male MH - Middle Aged MH - Patient Acceptance of Health Care/statistics & numerical data MH - Patient Satisfaction/statistics & numerical data MH - Wound Healing/physiology MH - Young Adult OTO - NOTNLM OT - Malawi OT - ShangRing device OT - male circumcision OT - safety EDAT- 2016/12/01 00:00 MHDA- 2019/01/29 06:00 CRDT- 2018/03/23 06:00 PHST- 2018/03/23 06:00 [entrez] PHST- 2016/12/01 00:00 [pubmed] PHST- 2019/01/29 06:00 [medline] AID - 10.29063/ajrh2016/v20i4.6 [doi] PST - ppublish SO - Afr J Reprod Health. 2016 Dec;20(4):60-66. doi: 10.29063/ajrh2016/v20i4.6.