Lina Posada Calderon, Spyridon P Basourakos, Karla V Ballman, Kaylee Ho, Mark A Barone, Quentin Awori, Daniel Ouma, Jairus Oketch, Alice Christensen, Augustino Hellar, Maende Makokha, Alphonce Isangu, Robert Salim, Jackson Lija, Ronald Gray, Stephen Kiboneka, Aggrey Anok, Godfrey Kigozi, Regina Nakabuye, Charles Ddamulira, Silas Odiya, Marc Goldstein, Philip S Li, Richard K Lee
{"title":"尚灵治疗早期男婴包皮环切术的安全性和有效性。","authors":"Lina Posada Calderon, Spyridon P Basourakos, Karla V Ballman, Kaylee Ho, Mark A Barone, Quentin Awori, Daniel Ouma, Jairus Oketch, Alice Christensen, Augustino Hellar, Maende Makokha, Alphonce Isangu, Robert Salim, Jackson Lija, Ronald Gray, Stephen Kiboneka, Aggrey Anok, Godfrey Kigozi, Regina Nakabuye, Charles Ddamulira, Silas Odiya, Marc Goldstein, Philip S Li, Richard K Lee","doi":"10.1136/bmjgh-2024-017903","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>Male circumcision (MC) has been shown to decrease transmission of HIV and is a critical strategy to decrease its incidence in countries with high rates of heterosexually transmitted HIV. Early infant MC (EIMC), with single-use MC devices, could increase rates of MC in Sub-Saharan Africa. Our objective was to determine the safety, efficacy and satisfaction of ShangRing EIMC in resource-constrained environments.</p><p><strong>Methods: </strong>Healthy male infants aged 1-60 days underwent ShangRing EIMC performed by non-physician clinicians in 14 sites in Kenya, Tanzania and Uganda. The primary outcomes were the safety and efficacy of ShangRing EIMC. Secondary outcomes were pain related to the procedure, wound healing and parental satisfaction. Male infants were assessed at discharge and on postoperative days 7 and 28 for wound healing and complications. This trial is registered with Clinical.</p><p><strong>Trials: </strong>gov, NCT03338699, and is complete.</p><p><strong>Results: </strong>From the 1697 participants enrolled from February to November 2020, 1691 (99.6%) underwent ShangRing EIMC. Median duration of the procedure was 10 min (IQR 6-13). The mean Neonatal Infant Pain Scale 20 min postprocedure was 0.3 (SD 0.8), indicating no pain. At the time of discharge, 1679 (99.0%) participants had a normal-appearing wound and 1574 (93.1%) demonstrated complete wound healing at 28 days. A total of 17 (1.0%) AEs were reported, most related to bleeding. A total of 1635 (99.1%) of parents were satisfied with the appearance of the circumcised penis at 28 days.</p><p><strong>Conclusion: </strong>ShangRing EIMC is a simple and successful MC method that non-physician clinicians can perform safely, with low AE rate, satisfactory wound healing and high satisfaction rate among parents. This indicates that the ShangRing EIMC can be considered a long-term strategic approach to accelerate the scale-up of MC in Sub-Saharan Africa.</p><p><strong>Trial registration number: </strong>NCT03338699.</p>","PeriodicalId":9137,"journal":{"name":"BMJ Global Health","volume":"10 9","pages":""},"PeriodicalIF":6.1000,"publicationDate":"2025-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12481264/pdf/","citationCount":"0","resultStr":"{\"title\":\"Safety and efficacy of the ShangRing for early infant male circumcision in the routine clinical setting.\",\"authors\":\"Lina Posada Calderon, Spyridon P Basourakos, Karla V Ballman, Kaylee Ho, Mark A Barone, Quentin Awori, Daniel Ouma, Jairus Oketch, Alice Christensen, Augustino Hellar, Maende Makokha, Alphonce Isangu, Robert Salim, Jackson Lija, Ronald Gray, Stephen Kiboneka, Aggrey Anok, Godfrey Kigozi, Regina Nakabuye, Charles Ddamulira, Silas Odiya, Marc Goldstein, Philip S Li, Richard K Lee\",\"doi\":\"10.1136/bmjgh-2024-017903\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>Male circumcision (MC) has been shown to decrease transmission of HIV and is a critical strategy to decrease its incidence in countries with high rates of heterosexually transmitted HIV. Early infant MC (EIMC), with single-use MC devices, could increase rates of MC in Sub-Saharan Africa. Our objective was to determine the safety, efficacy and satisfaction of ShangRing EIMC in resource-constrained environments.</p><p><strong>Methods: </strong>Healthy male infants aged 1-60 days underwent ShangRing EIMC performed by non-physician clinicians in 14 sites in Kenya, Tanzania and Uganda. The primary outcomes were the safety and efficacy of ShangRing EIMC. Secondary outcomes were pain related to the procedure, wound healing and parental satisfaction. Male infants were assessed at discharge and on postoperative days 7 and 28 for wound healing and complications. This trial is registered with Clinical.</p><p><strong>Trials: </strong>gov, NCT03338699, and is complete.</p><p><strong>Results: </strong>From the 1697 participants enrolled from February to November 2020, 1691 (99.6%) underwent ShangRing EIMC. Median duration of the procedure was 10 min (IQR 6-13). The mean Neonatal Infant Pain Scale 20 min postprocedure was 0.3 (SD 0.8), indicating no pain. At the time of discharge, 1679 (99.0%) participants had a normal-appearing wound and 1574 (93.1%) demonstrated complete wound healing at 28 days. A total of 17 (1.0%) AEs were reported, most related to bleeding. A total of 1635 (99.1%) of parents were satisfied with the appearance of the circumcised penis at 28 days.</p><p><strong>Conclusion: </strong>ShangRing EIMC is a simple and successful MC method that non-physician clinicians can perform safely, with low AE rate, satisfactory wound healing and high satisfaction rate among parents. 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Safety and efficacy of the ShangRing for early infant male circumcision in the routine clinical setting.
Introduction: Male circumcision (MC) has been shown to decrease transmission of HIV and is a critical strategy to decrease its incidence in countries with high rates of heterosexually transmitted HIV. Early infant MC (EIMC), with single-use MC devices, could increase rates of MC in Sub-Saharan Africa. Our objective was to determine the safety, efficacy and satisfaction of ShangRing EIMC in resource-constrained environments.
Methods: Healthy male infants aged 1-60 days underwent ShangRing EIMC performed by non-physician clinicians in 14 sites in Kenya, Tanzania and Uganda. The primary outcomes were the safety and efficacy of ShangRing EIMC. Secondary outcomes were pain related to the procedure, wound healing and parental satisfaction. Male infants were assessed at discharge and on postoperative days 7 and 28 for wound healing and complications. This trial is registered with Clinical.
Trials: gov, NCT03338699, and is complete.
Results: From the 1697 participants enrolled from February to November 2020, 1691 (99.6%) underwent ShangRing EIMC. Median duration of the procedure was 10 min (IQR 6-13). The mean Neonatal Infant Pain Scale 20 min postprocedure was 0.3 (SD 0.8), indicating no pain. At the time of discharge, 1679 (99.0%) participants had a normal-appearing wound and 1574 (93.1%) demonstrated complete wound healing at 28 days. A total of 17 (1.0%) AEs were reported, most related to bleeding. A total of 1635 (99.1%) of parents were satisfied with the appearance of the circumcised penis at 28 days.
Conclusion: ShangRing EIMC is a simple and successful MC method that non-physician clinicians can perform safely, with low AE rate, satisfactory wound healing and high satisfaction rate among parents. This indicates that the ShangRing EIMC can be considered a long-term strategic approach to accelerate the scale-up of MC in Sub-Saharan Africa.
期刊介绍：
BMJ Global Health is an online Open Access journal from BMJ that focuses on publishing high-quality peer-reviewed content pertinent to individuals engaged in global health, including policy makers, funders, researchers, clinicians, and frontline healthcare workers. The journal encompasses all facets of global health, with a special emphasis on submissions addressing underfunded areas such as non-communicable diseases (NCDs). It welcomes research across all study phases and designs, from study protocols to phase I trials to meta-analyses, including small or specialized studies. The journal also encourages opinionated discussions on controversial topics.
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