| Methods |
RCT, unblinded. |
| Participants |
96 participants. 68 men, 28 women. Mean age 23 years (range 13‐52). Both de novo and recurrent sinuses. |
| Interventions |
Midline closure (primary closure) vs. open healing. |
| Outcomes |
Healing time, recurrence, RTW, other complications, % initial healing. |
| Notes |
Complete follow up for at least one year; <80% drop out by 2 years. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
Quote: "participants were randomised .... by taking a card from a sealed envelope". No information about the method of randomisation. |
| Allocation concealment? |
Unclear risk |
Quote: "...by taking a card from a sealed envelope". No information about whether envelopes were sealed or sequential. |
| Incomplete outcome data addressed?
All outcomes |
High risk |
After randomisation, 4 participants were excluded from the closure group as closure was not possible. No information about the method of analysis used (e.g. intention to treat analysis). |
| Free of selective reporting? |
High risk |
Element of selective under reporting. Not enough information provided to incorporate time to wound healing data. |
| Free of other bias? |
Low risk |
|
