Yerdel 2001.
| Methods | Study: prospective, randomised. Allocation: computer. Blinding: yes. | |
| Participants | 269 patients: 136 P / 133 C. | |
| Interventions |
Hernioplasty ATB: Ampicilln‐sulbactam 1,5 gr IV. MA: before the incision. Control: placebo. |
|
| Outcomes | IP= 1; IC= 12 | |
| Notes | Because of the high rate of wound infections, the code was broken after the discharge of patient 280 (140 patients in each group). | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated code by a resident who also prepared the sealed antibiotic or placebo syringes. He was unaware of the research in progress and was never involved in surgery, data collection or patient follow‐up. |
| Allocation concealment (selection bias) | Low risk | Yes |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Yes |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Yes |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Yes |
P = prophylaxis group, C = control group, IP = infected with prophylaxis, IC = infected without prophylaxis, NM = not mentioned, ATB = antibiotic, MA = timing of prophylaxis administration