Methods |
RCT, unblinded |
Participants |
55 participants. 37 men, 18 women. Mean age 27 years. New and recurrence presentation. |
Interventions |
Off‐midline closure (Simple Bascom) vs. off‐midline closure ( Bascom's Cleft Closure). |
Outcomes |
Recurrence, RTW, wound healing rate |
Notes |
91% follow up at a mean of 36 months |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Adequate sequence generation? |
Unclear risk |
Quote: "Patients were randomized". |
Allocation concealment? |
Unclear risk |
Quote: "Patients were randomized by sequentially numbered sealed envelopes". No mention if they were opaque. |
Incomplete outcome data addressed?
All outcomes |
Unclear risk |
No information on exclusions, attrition, or missing data. |
Free of selective reporting? |
Low risk |
|
Free of other bias? |
Unclear risk |
It appears that before randomisation, participants were excluded from the study if they were not available for follow‐up evaluation. No information about the number of participants who were excluded or their characteristics. |