Sokal 2014.

Study characteristics
Methods	Design: parallel‐group open‐label RCT with 1‐to‐1 allocations conducted in 2 sites in Kenya. Designed as a superiority trial to prove superiority of Shang Ring over conventional circumcision. 400 men randomized. Ethical approval: FHI 360, the Kenya Medical Research Institute, and the University of Zambia. The Zambia Ministry of Health also granted permission to conduct the study Consent: participants provided informed consent. Duration of study: March–June 2011
Participants	Inclusion criteria: healthy uncircumcised, HIV‐negative men ages 18–54 years. Exclusion criteria: active genital infection, previous circumcision, an anatomic abnormality or another condition that contraindicated elective surgery under local anesthesia (e.g. bleeding diathesis, lidocaine allergy). Baseline characteristics: in both the Kenyan and Zambian groups, there were no differences in baseline characteristics between groups. The median age was 19 years in Kenya and 22.5 years in Zambia.
Interventions	Providers: 2 physicians and 2 nurses (experienced in conventional circumcisions and trained on SR) performed the procedures. Intervention group (SR): 200 participants. Local anesthetic (dorsal penile nerve and ring blocks injected with 1% lidocaine) and application of SR as per previous description in the literature. No specific mention of skin preparation techniques. Control group (conventional circumcision): 200 participants. Local anesthetic technique as above and conventional circumcision as per previous description in the literature. FG technique in Kenya and dorsal‐slit method in Zambia. Follow‐up: assessed on the 2nd, 7th, 14th, 21st, 28th, 35th, 42nd, 60th postoperative days for all groups.
Outcomes	Primary outcomes: safety assessed using the Public Services International/WHO Adverse Event Action Guide to classify adverse events as mild, moderate and severe moderate wound dehiscence: mucocutaneous gap of > 1 cm between wound edges pain and acceptability outcomes were assessed using a VAS ease of use and provider preferences measured duration of procedure (minutes) surgical difficulties encountered
Funding sources	Bill and Melinda Gates Foundation to FHI 360 (Grant OPPGH5166)
Declarations of interest	No conflicts of interest to disclose.
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Random sequences generated using permuted blocks with randomly chosen block size; low risk of selection bias.
Allocation concealment (selection bias)	Low risk	Allocation concealment was done using sequentially numbered, opaque, sealed, tamper‐evident envelopes. The unblinded nature of the trial coupled with block randomization could make allocations predictable; however, this was mitigated by use of random block size. Low risk of selection bias.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Blinding of participants and personnel was not possible with this surgical intervention and it was, therefore, unclear whether this may have impacted the performance of either group.
Blinding of outcome assessment (detection bias) Subjective outcomes (severe adverse events, moderate adverse events, minor adverse events, pain, patient satisfaction)	High risk	The outcome assessment was unblinded and would result in a possibility of detection bias for the subjective outcomes such as adverse effects.
Blinding of outcome assessment (detection bias) Objective outcomes (operative time)	Low risk	As the operative time was an objective outcome, the lack of blinding was not considered a risk of detection bias.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Attrition was clearly described in the published trial and was low for both groups.
Selective reporting (reporting bias)	Low risk	Study protocol available in ClinicalTrials.gov (NCT01300910) and the planned outcomes matched those reported in the trial; low risk of selective outcome reporting.
Other bias	Low risk	No other biases identified.