| Methods |
RCT, unblinded. |
| Participants |
380 participants. 355 men, 25 women. Mean age 22.6 years. New and recurrence sinuses. |
| Interventions |
Midline closure (simple excision with closure) vs open healing (simple excision without closure). |
| Outcomes |
Healing time, SSI, recurrence, RTW, , operating time. |
| Notes |
Follow up of 100% at a mean of 35.75 months. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Low risk |
Quote: "an equal number of envelopes with those two options were available in the operating room...Nurse mixed the envelopes". |
| Allocation concealment? |
Low risk |
Quote: "closed envelope randomisation...Opaque envelopes". |
| Incomplete outcome data addressed?
All outcomes |
Unclear risk |
Appropriately described valid reasons for exclusion. No information on attrition or missing data. |
| Free of selective reporting? |
Low risk |
|
| Free of other bias? |
Low risk |
|
