Trial reportPloS one2016
A Phase II Randomized Controlled Trial Comparing Safety, Procedure Time, and Cost of the PrePex™ Device to Forceps Guided Surgical Circumcision in Zimbabwe.
Trial report in PloS one, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01956370 (Phase II - Evaluation of Safety and Efficacy of the PrePexTM Device for Rapid Scale up of Adult Male Circumcision Programs in Zimbabwe), which is not on this map. Cited by 9 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Phase II - Evaluation of Safety and Efficacy of the PrePexTM Device for Rapid Scale up of Adult Male Circumcision Programs in Zimbabwe (Comparative Study)
Who cites it
9 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Systematic review: Safety of surgical male circumcision in context of HIV prevention public health programmes.Gates open research · 2022Pooled it
- Circumcision devices versus standard surgical techniques in adolescent and adult male circumcisions.The Cochrane database of systematic reviews · 2021Pooled it
- Reducing Provider Workload While Preserving Patient Safety: A Randomized Control Trial Using 2-Way Texting for Postoperative Follow-up in Zimbabwe's Voluntary Medical Male Circumcision Program.Journal of acquired immune deficiency syndromes (1999) · 2020Trial
- Trial
- Circumcision devices versus standard surgical techniques in adolescent and adult male circumcisions: a Cochrane review.BJU international · 2022Review
- Review of investigational medical devices' clinical trials and regulations in Africa as a benchmark for new innovations.Frontiers in medical technology · 2022Review
- Article
- Article
- Safety and efficacy of the PrePex device in HIV-positive men: A single-arm study in Zimbabwe.PloS one · 2017Article
Corrections and comments
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Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe World Health Organization (WHO) and the Joint United Nations Program on HIV/AIDS promote MC (male circumcision) as a key HIV prevention strategy where HIV prevalence and incidence are high and MC prevalence is low. In Zimbabwe, to achieve the 1.26 million circumcisions needed to be performed by 2015 to achieve optimal MC coverage, a new approach was needed. The primary objective of the current trial was to assess the performance (safety, procedure time, and cost) of the PrePex device compared to forceps-guided surgical circumcision. METHODS AND
findingsThis Phase II, randomized, open-label trial in Zimbabwe involved healthy, non-circumcised adult male volunteers who were randomly assigned to the PrePex device (n = 160) or surgical arm (n = 80). Three doctors and 4 nurses, all certified on both circumcision methods, performed the procedures. The PrePex device procedure involves a plastic ring with a rubber O-ring that necrotizes the foreskin to facilitate easy and minimally invasive removal. Total procedure time was the primary endpoint. Adverse event (AE) data were also gathered for 90 days post-procedure. All 80 participants in the surgical arm and 158 participants in the PrePex arm achieved complete circumcision. The total procedure time for the PrePex device was approximately one-third of the total surgical procedure (4.8 minutes, Standard Deviation [SD]: 1.2 versus 14.6 minutes; SD: 4.2; p<0.00001). There were 2 AEs for 2 participants (rate of 1.3%, 95% Confidence Interval: 0.0025-4.53%), which were resolved with simple intervention. The AEs were device related, including 1 case of pain leading to device removal and 1 case of removal of the device.
conclusionsThe trial supports previous studies' conclusions that the PrePex procedure is safe, quick, easy to apply, and effective in terms of procedure time as an alternative to traditional surgical circumcision. The PrePex device has great potential for use in overburdened health systems and in resource-limited settings and is recommended for use in rapid scale-up of adult MC in Zimbabwe.
trial registrationClinicalTrials.gov NCT01956370.
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