| Methods |
RCT, unblinded. |
| Participants |
46 participants. 37 men, 9 women, Mean age 22.5 years. New sinus presentation only. |
| Interventions |
Closed midline (midline primary closure) vs. closed off‐midline (rhomboid flap) |
| Outcomes |
SSI rate, recurrence rate, RTW, LOS, % healed wounds. |
| Notes |
Complete follow‐up at 18 months. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
Quote: "Randomly allocated". No information about randomisation method. |
| Allocation concealment? |
Unclear risk |
Quote: "allocated by a system of sequentially numbered sealed envelopes". No information about whether envelopes were opaque. |
| Incomplete outcome data addressed?
All outcomes |
Unclear risk |
No data reported on exclusions, attrition or missing data. |
| Free of selective reporting? |
High risk |
Element of selective under‐reporting. Data on time to complete wound healing were reported for closed off‐midline group but not for the midline closure group. |
| Free of other bias? |
Low risk |
|
