Lewis 2002.
Study characteristics | |
Methods |
Study design: Parallel‐group randomised trials Duration of trial: 1992 ‐ 1995 Duration of follow‐up: Quote: "The patients were followed up by the infection control nurse on postoperative days 3, 5 to 7, 10 to 14, and at 1 month for diagnosis of surgical site infection, using the modified CDC criteria." Country of origin: Canada |
Participants |
Baseline characteristics
Number randomised: 215 participants
Number analysed: 213 participants Intervention: MBP+oAB
Control: MBP
Inclusion criteria Quote: "All patients who underwent elective surgery of the colon at the Queen Elizabeth Hospital in Montreal were eligible to enter the study" Exclusion criteria Quote: "Patients who were allergic to the study antibiotics or who had received antibiotics within the 2 weeks before operation, pregnant patients and those who refused informed consent were excluded." Baseline imbalances Quote: "The treatment groups were evenly matched with respect to age, gender, body mass index and preoperative serum albumin level and blood lymphocyte count. There were no significant differences between the groups with respect to the preoperative final diagnoses and operations performed." |
Interventions |
Comparison
MBP
oAB
Perioperative intravenous antibiotic prophylaxis
Adherence to regimen: ‐ |
Outcomes |
Outcomes sought in review and reported in trial
Outcomes sought but not reported in trial
Outcomes reported in trial but not used in review
|
Notes |
Source of funding: ‐ Conflicts of interest: ‐ Ethics approval: ‐ Informed consent: Quote: "All patients gave informed consent to participate in the study" Clinical trials registration: ‐ Sample size calculation:Quote: "The sample size was calculated assuming an infection rate at the surgical site of 10% to 15%, and a treatment difference of 10% (α risk 0.05, β risk 0.20)" |