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.

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.

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).

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

Methods

Randomised controlled trial.
Randomised from a 'list' in theatre.
No information on allocation concealment.
Caregivers (surgeons) not blinded.
No information on whether participants were blinded.
Outcome assessors not blinded but were "encouraged not to refer to the randomisation list" until after assessing the wound.

Participants

164 women undergoing caesarean section.
It is not clear how many women were in the closure group and how many were in the non‐closure group.

Excluded if prescribed antibiotics in the two weeks prior to caesarean, or if given antibiotics for cardiac prophylaxis.
Included if: first or repeat caesarean; prelabour or intrapartum caesarean; obese or 'non‐obese'.
All women in the trial had transverse skin incisions and no wound drains were used.

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 82 women in the closure group and 77 women in the non‐closure group.
Loss to follow up: 5 women. It is not clear from the paper which randomised group they were from.
No significant difference in complications between the closure and the non‐closure groups.

Wounds assessed during hospital admission. Women were asked to return to the hospital "if they developed any problems".

Notes

Turkey. 1995 to 1997.
Two groups of results reported; women with < 2 cm fat and women with > 2 cm fat.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

Randomised controlled trial.
Randomisation by computer‐generated 'permuted blocks' at the time of caesarean section.
Numbers kept in opaque envelopes. No information on whether all envelopes were accounted for.
Caregivers (surgeons) not blinded.
Participants blinded.
Outcome assessors were 'effectively' blinded because the allocation was not recorded in the notes, but some dictated operative reports may have been available.

Participants

327 women undergoing caesarean section.
162 women in the closure group and 165 women in the non‐closure group.

Excluded if delayed primary closure or drain insertion was planned preoperatively.
Included if: first or repeat caesarean; prelabour or intrapartum caesarean; obese or 'non‐obese'; longitudinal or transverse skin incision.
No wound drains were used.

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 135 in the closure group and 143 in the non‐closure group.
Loss to follow up: 27 women in the closure group; 22 women in the non‐closure group.
No significant difference in complications between the closure and the non‐closure groups.

Outcomes assessed at a postpartum visit (4 to 8 weeks postpartum).

Notes

USA. 1995 to 1997.
631 women delivered by caesarean section; 327 enrolled in the study.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

A ‐ Adequate

Methods

Randomised controlled trial.
Randomisation by computer‐generated list of numbers kept in delivery suite.
No information on allocation concealment.
Caregivers (surgeons) not blinded.
No information on whether participants were blinded.
Outcome assessors were not blinded but were "encouraged not to look at the randomisation list until after assessing the wound".

Participants

451 women undergoing caesarean section.
It is not clear how many women were randomised to the closure group and how many women were randomised to the non‐closure group.

No stated exclusion criteria.
Included if: first or repeat caesarean; prelabour or intrapartum; longitudinal or transverse skin incision.

No information on whether the women were obese or 'non‐obese'. Mean body mass index in both groups was greater than 30 kg/m2.
No information on wound drain use.

Interventions

Treatment group: closure of the camper fascia.
Control group: non‐closure of the camper fascia.

Outcomes

Superficial wound disruption incidence (including wound infection, haematoma or seroma) available on 222 women in the closure group and 216 women in the non‐closure group.
Loss to follow up: 13 women. It is not clear from the paper which randomised groups they were from.
There were fewer wound complications in the closure group compared with the non‐closure group.

Wounds assessed during hospital admission. Women were asked to return to the hospital "if they developed any problems". A chart review was also carried out at six weeks postpartum.

Notes

USA. 1991 to 1992.
Results were not reported by randomised group.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

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.

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.

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.

Notes

USA. 1998 to 2001.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

A ‐ Adequate

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.

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.

Notes

USA. 1991 to 1993.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

A ‐ Adequate

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.

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.

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.

Notes

UK. 1994 to 1995.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

A ‐ Adequate