| Methods |
Study design: randomised controlled trial. Object of randomisation: operations. |
| Participants |
USA. Surgeons and assistants performing caesarean sections. Closure of all anatomical layers. Number studied: 194 operations. Intervention group n = 204 surgeon‐operations. Control group n = 204 surgeon‐operations. All gloves collected. |
| Interventions |
Use of blunt needles. The control group used sharp needles. |
| Outcomes |
Outcome: number of glove perforations per operation. Perforation detection: the gloves were filled with water and perforations were noted as jets of water. |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
computerised random sequence generator |
| Allocation concealment (selection bias) |
Unclear risk |
surgeon nor assistant blinded to randomisation outcome |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
surgeon nor assistant blinded to randomisation outcome; blinding to type of needle is impossible for surgeons |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
the (testing) author was blind to which needle had been used |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
100% completion of surveys |
| Selective reporting (reporting bias) |
Low risk |
all outcomes reported |
