Magann 2002.
Methods | Randomised controlled trial. Randomisation by random number. 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 blind to the randomised allocations. | |
Participants | 964 women undergoing caesarean section were randomised preoperatively.
590 women undergoing caesarean section were deemed eligible intra‐operatively because they had more than 2 cm of subcutaneous fat.
191 women in the closure group and 399 women in the non‐closure group Excluded if: no time for adequate consent; less than 2 cm of subcutaneous fat (when measured intraoperatively). Included if: first or repeat caesarean; prelabour or intrapartum caesarean; vertical or transverse skin incision. |
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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, wound complication and endometritis incidence available on all randomised women at staple removal (7 to 10 days postpartum).
Mean blood loss and mean duration of operation also available.
No loss to follow up documented at discharge from hospital.
No significant difference in complications between the closure and the non‐closure groups. Unclear at which point in the follow up the recorded outcomes were diagnosed. |
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Notes | USA. 1998 to 2001. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Low risk | A ‐ Adequate |