ShangRing versus Mogen clamp for early infant male circumcision in eastern sub-Saharan Africa: a multicentre, non-inferiority, adaptive, randomised controlled trial
In: The Lancet Global Health, Jg. 10 (2022), Heft 10, S. e1514-e1522
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Summary: Background: Use of medical devices represents a unique opportunity to facilitate scale-up of early infant male circumcision (EIMC) across sub-Saharan Africa. The ShangRing, a circumcision device prequalified by WHO, is approved for use in adults and adolescents and requires topical anaesthesia only. We aimed to investigate the safety and efficacy of the ShangRing versus the Mogen clamp for EIMC in infants across eastern sub-Saharan Africa. Methods: In this multicentre, non-inferiority, open-label, randomised controlled trial, we enrolled healthy male infants (aged
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ShangRing versus Mogen clamp for early infant male circumcision in eastern sub-Saharan Africa: a multicentre, non-inferiority, adaptive, randomised controlled trial
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| Autor/in / Beteiligte Person: | Spyridon P Basourakos, MD ; Quincy G Nang, MD, MPH ; Karla V Ballman, ProfPhD ; Omar Al Hussein Al Awamlh, MD ; Nahid Punjani, MD ; Kaylee Ho, BSc ; Mark A Barone, DVM ; Quentin D Awori, MBChB ; Daniel Ouma, BSc ; Jairus Oketch, KRCHN ; Alice E Christensen, CNS ; Augustino Hellar, MMed ; Maende Makokha, MSPH ; Alphonce Isangu, BA ; Robert Salim, MD ; Jackson Lija, MMed ; Ronald H Gray, ProfPhD ; Stephen Kiboneka, MBChB ; Aggrey Anok, BSc ; Godfrey Kigozi, PhD ; Regina Nakabuye, DCM ; Charles Ddamulira, DCM ; Andrew Mulooki, DCM ; Silas Odiya, DCM ; Rose Nazziwa, DCM ; Marc Goldstein, ProfMD ; Philip S Li, ProfMD ; Richard K Lee, MD, MBA |
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| Zeitschrift: | The Lancet Global Health, Jg. 10 (2022), Heft 10, S. e1514-e1522 |
| Veröffentlichung: | Elsevier, 2022 |
| Medientyp: | academicJournal |
| ISSN: | 2214-109X (print) |
| DOI: | 10.1016/S2214-109X(22)00326-6 |
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