| Methods |
Study design: randomised controlled trial according to operation date and time. Object of randomisation: operations |
| Participants |
Germany. Attending surgeon and assistant during abdominal closure: fascia and muscle. Number studied 100 operations (400 gloves). Intervention group n = 98 surgeon‐operations (196 gloves) Control group n = 102 surgeon‐operations (204 gloves) Gloves changed before closure. |
| Interventions |
Use of blunt needles to close the abdominal fascia. Control group used sharp needles |
| Outcomes |
Outcome 1. Number of perforations in gloves. 2. Force needed to use the needle 3. Ease of use of the needle. Gloves were filled with water and perforations were noted as jets of water |
| Notes |
Information from author:The surgeon called the study nurse while changing his gloves before closure of the laparotomy. Therefore, only elective surgery has been included in this study. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Randomisation was done according to operation date and time according to a random number list. |
| Allocation concealment (selection bias) |
Low risk |
Randomisation was done according to operation date and time |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Not reported; not possible |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
The person, who assessed the globes, identified the procedure by participant´s name + OP‐book number. Surgeon´s opinion was evaluated separately. (information from author) |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
All gloves reported |
| Selective reporting (reporting bias) |
Low risk |
All outcomes reported |
