| Methods |
RCT, unblinded. |
| Participants |
200 participants. 168 men, 32 women. Mean age 27 years range 15‐60. New sinus presentation. |
| Interventions |
Midline closure (excision and primary closure) vs. off‐midline closure (rhomboid excision and Limberg flap). |
| Outcomes |
SSI rate, recurrence rate, RTW, other complications, LOS, pain score. |
| Notes |
100% follow‐up at 2 years. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Low risk |
Quote: "Randomly allocated....Computer generated table of random numbers". |
| Allocation concealment? |
Low risk |
Quote: "The randomization was carried out by an independent computer consultant". |
| Incomplete outcome data addressed?
All outcomes |
Low risk |
No participants were lost to follow up. |
| Free of selective reporting? |
Low risk |
|
| Free of other bias? |
Low risk |
|
