Allaire 2000.
Methods | Randomised controlled trial. Randomisation by computer generated random number sequence, after fat depth had been measured. Numbers kept in opaque envelopes. No information on whether all envelopes were accounted for. Caregivers (surgeons) not blinded. No information on whether participants or outcome assessors were blinded. | |
Participants | 76 women undergoing caesarean section with more than 2 cm of subcutaneous fat.
26 women in the closure group and 50 women in the non‐closure group. Excluded if no time for adequate consent. Included if: first or repeat caesarean; prelabour or intrapartum caesarean. The type of skin incision was not described. |
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Interventions | Treatment group: closure of the subcutaneous tissue.
Control group for this review: non‐closure of the subcutaneous tissue (with or without subcutaneous drain). Three randomised groups: closure of subcutaneous tissue; subcutaneous drain used; no closure of subcutaneous tissue or use of subcutaneous drain. |
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Outcomes | Wound infection and wound complication incidence available on all randomised women.
No loss to follow up documented.
No significant difference in complications between the closure and the non‐closure groups. Wounds assessed prior to discharge and at staple removal (7 to 10 days postpartum). Further complications identified by retrospective chart review (timing not stated). |
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Notes | USA. 1995 to 1997. 1109 women delivered by caesarean section; 76 enrolled in the study. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Low risk | A ‐ Adequate |