Surgical Technique Clinical Trial
Official title:
A Randomized Controlled Trial of Open Surgical vs. Minimally-invasive Voluntary Adult Male Circumcision
This proposed randomized controlled trial will provide important data which will inform and enable the Mozambican government and global health programs to more effectively scale-up circumcision services. The investigators postulate that voluntary medical male circumcision using the Gomco clamp coupled with tissue adhesive meets WHO criteria for the ideal method: it is much easier to learn, faster, safer for both surgeons and patients, heals sooner, and is more cost effective than any other currently available technique.
Voluntary medical male circumcision (VMMC) is a priority preventive intervention and
Mozambique is a priority country for VMMC scale-up. PEPFAR recently estimated that one HIV
infection would be prevented between now and 2025 for every seven circumcisions performed in
Mozambique. Sofala Province, where the study will be conducted, has an HIV prevalence of 13%
among men and 18% among women. Approximately 8% of men aged 15-49 in Sofala Province, where
the study will take place, are currently circumcised.
In spite of their widely acknowledged drawbacks, open surgical techniques are the only VMMC
techniques the President's Emergency Plan for AIDS Relief (PEPFAR) program currently allows
in Africa. According to the Framework for Clinical Evaluation of Devices for Adult Male
Circumcision (WHO, 2011): "WHO and other health authorities wish to identify one or more
devices that (a) would make the VMMC safer, easier, and quicker; (b) would have more rapid
healing than current methods and/or might entail less risk of HIV transmission in the
post-operative period; (c) could be performed safely by health-care providers with a minimal
level of training; and (d) would be cost-effective compared to standard surgical methods for
male circumcision scale up."
This proposed randomized controlled trial will provide important data which will inform and
enable the Mozambican government and PEPFAR to more effectively scale-up circumcision
services. The investigators postulate that VMMC using the Gomco clamp coupled with tissue
adhesive meets WHO criteria for the ideal method: it is much easier to learn, faster, safer
for both surgeons and patients, heals sooner, and is more cost effective than any other
currently available technique.
The investigators propose a randomized controlled trial (RCT) comparing this
minimally-invasive circumcision technique to the open surgical technique:
- Gomco clamp with tissue adhesive: 100 men
- Open surgical circumcision: 100 men
The Gomco clamp is an FDA-approved device widely used in the US, but there are few data on
its use in Africa. Tissue adhesive is widely used in multiple areas of medicine;
specifically, multiple observational studies and RCTs have shown cyanoacrylate tissue
adhesives to be superior to suture closure in circumcision in boys. The investigators refer
to Gomco clamp circumcision coupled with tissue adhesive as a 'new' technique because these
two independently-validated components have only been coupled in observational studies among
men, and in randomized controlled trials among pre-pubertal boys, but never before in an RCT
among adult men. The open surgical method is PEPFAR-approved and will serve as the control
intervention.
Population: Men > 18 years of age who desire male circumcision Sample size: 200 (100 men in
each group) Study design: Randomized controlled trial Intervention: Gomco clamp circumcision
plus tissue adhesive vs. open surgical circumcision Follow-up visits: 2 days, 7 days, 14
days and 28 days. Optional 42 day follow-up if not completely healed by 4 weeks.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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