| Methods |
Randomised controlled trial.
Single centre (Canadian) study between September 1985 and October 1988.
Randomisation method: unclear.
Blinding of assessors: not stated.
Patient stratification: using APACHE II score.
Power calculation: not performed.
Intention‐to‐treat analysis: not performed.
Sub‐group analysis: not performed.Follow up: not stated. |
| Participants |
Number of patients: 104.
52 (Imipenem/cilastatin, I‐C) versus 52 (Tobramycin/antianaerobe, T‐A).
Mean age: 52.0 (I‐C), 57.6 (T‐A).
Mean APACHE II Score: 11.2 (I‐C), 13.1(T‐A).
Inclusion criteria: patients admitted for emergency surgery with suspected intra‐abdominal infection.
Exclusion criteria: pregnant, gynaecological and perianal infections, overt renal failure requiring dialysis, concomitant CNS infection and known allergy to study drugs, uncomplicated cholecystitis, appendicitis without perforation, traumatic bowel perforation < 12 hours and perforated peptic ulcer < 24 hours. |
| Interventions |
2 regimens:
1) Imipenem/cilastatin 500 mg (6 hourly).
2) Tobramycin 1.5 mg/kg (8 hourly) and either clindamycin 600 mg (6 hourly) or metronidazole 500 mg (6 hourly).
Tobramycin level monitored at peak 6‐10 mcg/ml and trough < 1.5 mcg/ml.
Timing of antibiotic infusion: not stated.
Length: not stated. |
| Outcomes |
Clinical success.
Mortality. |
| Notes |
% of appendicitis patients: not stated.No statistically significant difference shown. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Unclear risk |
B ‐ Unclear |
