Stafford 1998.
Methods | Randomised controlled trial. Randomisation by shuffling sealed envelopes containing needles. No information on whether all envelopes were accounted for. Caregivers (surgeons) not blind. No information on whether participants or outcome assessors were blind to the randomised allocations. | |
Participants | 204 women undergoing caesarean section.
97 women in the blunt needle group and 106 women in the sharp needle group. 1 woman excluded ‐ allocation not known. No stated exclusion criteria. Included if: first or repeat caesarean; prelabour or intrapartum caesarean. The caesarean sections were consecutive and used a transverse skin incision. No information on obesity of patients or wound drain use. |
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Interventions | Treatment group: closure of the uterus, peritoneum and rectus sheath using dexon with blunt needles (fat closure optional).
Control group: closure of the uterus, peritoneum and rectus sheath using dexon with sharp needles (fat closure optional). One woman excluded because unable to use dexon throughout the operation. |
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Outcomes | Wound infection incidence available on 97 women in the blunt needle group and on 106 women in the sharp needle group at discharge (four days postnatally).
Loss to follow up: 1 woman excluded at surgery. No other loss to follow up at discharge.
Follow up at six weeks achieved for 61 women in the blunt needle group and 71 women in the sharp needle group. No significant difference in complications between the blunt needle and the sharp needle groups. Wounds assessed at discharge. |
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Notes | UK. 1994 to 1995. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Low risk | A ‐ Adequate |