Nordkam 2005.
| Methods | Study design: randomised controlled trial. Object of randomisation: patients. | |
| Participants | Netherlands. Surgeons and assistants performing laparotomies, abdominal closure: fascia. Number studied: 200 procedures, 400 operators and 406 pairs of gloves. Intervention group n = 200 surgeon‐operations. Control group n = 100 surgeon‐operations. Gloves changed before skin closure. | |
| Interventions | Use of blunt‐tapered needles. Control group used sharp needles. | |
| Outcomes | Outcome: Number of procedures with one or more glove perforations per total number of procedures. Outcome calculated: holes in gloves per operator per operation Perforation detection: The gloves were filled with water and perforations were noted as jets of water. Secondary outcome: Ease of use of the needles. |
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| Notes | We received additional information from the authors | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | randomisation by envelope; authors wrote that randomisation was based on a computer generated random number |
| Allocation concealment (selection bias) | Low risk | "just before closure of the fascia"; randomisation by envelope |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | team was aware of type of needle used; blinding to type of needle is impossible for surgeons |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | not reported; authors wrote that observer was blind to which needle was used |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | all gloves retrieved |
| Selective reporting (reporting bias) | Low risk | all outcomes reported |