Naumann 1995.
Methods | Randomised controlled trial. Randomisation by computer generated random number sequence at time of surgery. Numbers kept in sealed envelopes. No information on whether all envelopes were accounted for. Caregivers (surgeons) not blinded. No information on whether participants were blinded. Outcome assessors were blind to the randomised allocations. | |
Participants | 245 women undergoing caesarean section with more than 2 cm of subcutaneous fat.
117 women in the closure group and 128 women in the non‐closure group. No stated exclusion criteria. Included if: first or repeat caesarean; prelabour or intrapartum caesarean, longitudinal or transverse skin incision. No information on wound drain use. |
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Interventions | Treatment group: closure of the subcutaneous fat. Control group: non‐closure of the subcutaneous fat. | |
Outcomes | Wound infection and wound complication incidence available on all randomised women. Outcomes assessed at hospital discharge, and at staple removal (7 to 10 days postnatally). There were significantly fewer wound complications in the closure group than in the non‐closure group. |
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Notes | USA. 1991 to 1993. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Low risk | A ‐ Adequate |