| Methods |
RCT, unblinded. |
| Participants |
140 participants. 118 men, 22 women. Mean age 23.8 years. New sinuses only. |
| Interventions |
Open healing (unroofing & Marsupialisation) vs off‐midline closure (rhomboid excision and classic Limberg flap). |
| Outcomes |
healing time, SSI, RTW, other complications, QOL, pain, operative time, time to sitting without pain, time to return to daily activities without pain, time to walk with out pain. |
| Notes |
Patients were follow up for a mean of 15 months. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Low risk |
Quote: "computer generated table of random numbers, we randomly assigned participants..". |
| Allocation concealment? |
Unclear risk |
Not reported. |
| Incomplete outcome data addressed?
All outcomes |
Unclear risk |
All participants in both groups were followed up on an outpatient basis until the healing was complete. No information about exclusion, attrition, or missing data. |
| Free of selective reporting? |
Low risk |
|
| Free of other bias? |
Unclear risk |
The study used telephone or outpatient appointments to assess further recurrence after data analyses but numbers by method were not specified. |
