The Safety Profile and Acceptability of a Disposable Male Circumcision Device in Kenyan Men Undergoing Voluntary Medical Male Circumcision

Musau, P; Demirelli, Mustafa; Muraguri, Nicholas; Ndwiga, Francis; Wainaina, Daniel; Ali, Nabila Amin

doi:10.1016/j.juro.2011.07.027

Cited by 10 publications

(9 citation statements)

References 8 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…[3][4][5] In the world various MC methods exist. 6,7 In the WHO MC manual 3 adult techniques are included, including dorsal slit, forceps guided and sleeve resection. 8 However, there is a continuing need to improve the safety and efficacy of the circumcision procedure, which may involve improving procedures and devices.…”

mentioning

confidence: 99%

RETRACTED: A Randomized Clinical Study of Circumcision with a Ring Device Versus Conventional Circumcision

Cheng

Yan

et al. 2012

Journal of Urology

View full text Add to dashboard Cite

show abstract

mentioning

confidence: 99%

RETRACTED: A Randomized Clinical Study of Circumcision with a Ring Device Versus Conventional Circumcision

Cheng

Yan

et al. 2012

Journal of Urology

View full text Add to dashboard Cite

show abstract

“…However, the rapid expansion of VMMC programs has raised questions regarding the extent to which health systems can deliver VMMC according to minimum quality standards which are sustained at-scale [8], [9]. Ensuring correct performance of VMMC procedures during scale-up is essential in realizing the potential health impact of averted HIV infections and in reducing health systems costs for HIV-related care [10], [11].…”

Section: Introductionmentioning

confidence: 99%

Quality of Voluntary Medical Male Circumcision Services during Scale-Up: A Comparative Process Evaluation in Kenya, South Africa, Tanzania and Zimbabwe

et al. 2014

View full text Add to dashboard Cite

BackgroundThe rapid expansion of voluntary medical male circumcision (VMMC) has raised concerns whether health systems can deliver and sustain VMMC according to minimum quality criteria.Methods and FindingsA comparative process evaluation was used to examine data from SYMMACS, the Systematic Monitoring of the Voluntary Medical Male Circumcision Scale-Up, among health facilities providing VMMC across two years of program scale-up. Site-level assessments examined the availability of guidelines, supplies and equipment, infection control, and continuity of care services. Direct observation of VMMC surgeries were used to assess care quality. Two sample tests of proportions and t-tests were used to examine differences in the percent of facilities meeting requisite preparedness standards and the mean number of directly-observed surgical tasks performed correctly. Results showed that safe, high quality VMMC can be implemented and sustained at-scale, although substantial variability was observed over time. In some settings, facility preparedness and VMMC service quality improved as the number of VMMC facilities increased. Yet, lapses in high performance and expansion of considerably deficient services were also observed. Surgical tasks had the highest quality scores, with lower performance levels in infection control, pre-operative examinations, and post-operative patient monitoring and counseling. The range of scale-up models used across countries additionally underscored the complexity of delivering high quality VMMC.ConclusionsGreater efforts are needed to integrate VMMC scale-up and quality improvement processes in sub-Saharan African settings. Monitoring of service quality, not just adverse events reporting, will be essential in realizing the full health impact of VMMC for HIV prevention.

show abstract

“…Various non-disposable [13,14] and disposable [9,15] circumcision devices have been developed that effectively prevent intraoperative bleeding by clamping the superficial dorsal veins and vessels between an inner and outer ring prior to transection of the foreskin, allowing the foreskin to be removed surgically or by natural atrophy. As a result, these techniques produce very little bleeding and may limit infection, pain, and other risks associated with adult MC [9,13–15].…”

Section: Discussionmentioning

confidence: 99%

“…As a result, these techniques produce very little bleeding and may limit infection, pain, and other risks associated with adult MC [9,13–15]. In comparison, the superficial dorsal vein of the penis is directly ligated during conventional MC surgery and hemostasis is achieved with sutures, causing a relatively large amount of intraoperative bleeding [7].…”

Section: Discussionmentioning

confidence: 99%

Safety and efficacy of a novel disposable circumcision device: A pilot randomized controlled clinical trial at 2 centers

Wang

Zhou²,

Xia³

et al. 2014

Med Sci Monit

View full text Add to dashboard Cite

BackgroundWe evaluated the safety and efficacy of a novel disposable male circumcision (MC) device developed by Jiangxi-Yuansheng-Langhe Medical Instrument Co., Ltd.Material/MethodsAdult male patients (n=120; mean age, 26.6 years) with redundant foreskin and/or phimosis were included in a randomized, multicenter pilot clinical trial from October 2011 to February 2012. Patients were divided into 2 groups and subjected to MC with a novel disposable device (Device Group) (n=60) or to conventional dissection technique (CDT) (Control Group) (n=60). Intraoperative bleeding, surgery duration, pain, healing, and satisfaction with penis appearance were assessed. Adverse events (AEs) were noted.ResultsIntraoperative bleeding volume [3.5±2.7 (15–35) ml vs. 13.1±6.1 (4–25) ml] and mean surgical time [7.6±4.5 (2–23) min vs. 23.6±4.4 (15–35) min] in the Device Group were significantly less than in the Control Group (P<0.01). No AEs were observed in either group. There were no significant differences in postoperative pain, healing, or satisfaction with penis appearance between groups (P>0.05).ConclusionsThis novel disposable circumcision device produced satisfactory preliminary adult MC results compared with CDT treatments. This device may be broadly used in men, such as those with phimosis, who are ineligible for CDT.

show abstract

The Safety Profile and Acceptability of a Disposable Male Circumcision Device in Kenyan Men Undergoing Voluntary Medical Male Circumcision

Cited by 10 publications

References 8 publications

RETRACTED: A Randomized Clinical Study of Circumcision with a Ring Device Versus Conventional Circumcision

RETRACTED: A Randomized Clinical Study of Circumcision with a Ring Device Versus Conventional Circumcision

Quality of Voluntary Medical Male Circumcision Services during Scale-Up: A Comparative Process Evaluation in Kenya, South Africa, Tanzania and Zimbabwe

Safety and efficacy of a novel disposable circumcision device: A pilot randomized controlled clinical trial at 2 centers

Contact Info

Product

Resources

About