| Methods |
Study design: cluster‐randomised controlled trial
Object of randomisation: patient (operation) |
| Participants |
Denmark
Surgeons, assistants and scrub nurses performing elective gastrointestinal surgery
Number studied: 566 glove pairs
Intervention group n = 260; control group n = 306 |
| Interventions |
Double gloving with indicator system
Control group was single gloved |
| Outcomes |
Outcome: number of perforations per total number of gloves
Perforation detection: the gloves were filled with water and perforations were noted as a jet of water
Secondary outcomes: incidence of blood contamination of the hands, self detection of glove perforations during surgery |
| Notes |
— |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation |
Unclear risk |
Procedure not described |
| Allocation concealment |
Unclear risk |
No information |
| Blinding of study subjects |
Low risk |
Not possible; knowledge about the gloving method judged as having a low risk of changing the outcome |
| Blinding of outcome assessor |
Unclear risk |
No information |
| Incomplete outcome data (attrition bias) |
Unclear risk |
Some people used more than one pair of gloves but only the first pair was included in analysis; number of excluded cases not reported |
| Selective outcome reporting (reporting bias) |
Low risk |
Punctures in inner and outer gloves |
| Outcome measure (combined air and water test used?) |
High risk |
Water test only, filled with water (EN 455‐1) |
