| Methods |
Study design: randomised controlled trial
Object of randomisation: patients |
| Participants |
Thailand
Primary surgeons in 300 caesarean sections in an antenatal clinic
Number randomised: 300
Intervention group n = 150; control group n = 150 |
| Interventions |
Double gloves worn by surgeons in the intervention group (150 glove sets)
The control group wore single gloves (150 glove pairs) |
| Outcomes |
Outcome: the number of perforations per total number of glove pairs
Measurement: both matching inner‐outer perforations and double‐inner perforations were recorded in the intervention group
Perforation detection: the gloves were filled with air and then immersed in water and perforations were noted as air bubbles |
| Notes |
— |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation |
Low risk |
Sealed envelopes, 1 out of 2 |
| Allocation concealment |
Low risk |
Randomisation at the time of operation |
| Blinding of study subjects |
Low risk |
Knowledge about the gloving method judged as low risk of changing the outcome |
| Blinding of outcome assessor |
High risk |
Bags with gloves were labelled with method and other information |
| Incomplete outcome data (attrition bias) |
Unclear risk |
Not reported |
| Selective outcome reporting (reporting bias) |
Low risk |
Glove perforation rates |
| Outcome measure (combined air and water test used?) |
High risk |
Air test only, filling with air and immersing in water |
