| Methods |
Double‐blinded, randomised controlled trial.
Single centre (USA) study between April 1982 and June 1983.
Randomisation method: computer generated random numbers.
Blinding of assessors: double‐blinded.
Patient stratification: not performed.
Power calculation: not used.
Intention‐to‐treat analysis: not performed.
Sub‐group analysis: not performed.Follow up: 6 months.
Placebos were used to maintain double‐blinding. |
| Participants |
Number of patients: 197.
Clinically evaluable patients: 105.
67 (Ampicillin/sulbactam, A‐S) versus 38 (Gentamicin/clindamycin, G‐C).
Mean age: 27.8 (A‐S), 26.7 (G‐C).
Inclusion criteria: patients with perforated and gangrenous appendicitis (fever > 38 degrees C, duration of symptoms > 24 hours, diffuse abdominal tenderness and WBC count > 13000).
Exclusion criteria: < 16 or > 75 years old, pregnant women and patients who had received antimicrobial therapy in the preceding 6 weeks. |
| Interventions |
2 regimens:
1) Ampicillin 2 G and sulbactam 1 G (6 hourly).
2) Gentamicin 1.5 mg/kg (8 hourly) and clindamycin 600 mg (6 hourly).
Gentamicin levels were monitored at peak 6 +/‐ 2 mcg/ml.
Timing of antibiotic infusion: prior to operation.
Length: afebrile for > 48 hours. |
| Outcomes |
Clinical success.
Wound infection and intra‐abdominal abscess.
Adverse reactions.
Duration of therapy, hospital stay and defervescence.. |
| Notes |
All patients had complicated appendicitis.
Trial had shown difference in clinical success rate in favour of gentamicin/clindamycin regimen.
Study supported by grant from Pfizer. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Low risk |
A ‐ Adequate |
