| Methods |
Randomised, double blinded controlled trial.
Single centre (USA) study.
Randomisation method: computer generated cards.
Assessors were blinded.
Patient stratification: not performed.
Power calculation: not performed.
Intention‐to‐treat analysis: not performed.
Sub‐group analysis: performed.
Follow up: not stated.
Placebo was used to maintain double‐blinding. |
| Participants |
Number of patients: 237.
Clinically evaluable patients: 130.
40 (Gentamicin/clindamycin, G‐C) versus 48 (Cefamandole) versus 42 (Cefoperazone).
Mean age +/‐ standard deviation: 30 +/‐ 1.6 (G‐C), 28 +/‐ 1.4 (Cefamandole), 29 +/‐ 1.5 (Cefoperazone).
Age range: 17‐64.
Inclusion criteria: duration of symptoms greater than 24 hours, diffuse abdominal tenderness, temperature > 101 degrees F, white blood cell count > 13000/mm3.
Exclusion criteria: < 16 or > 65 years old, pregnant or breast feeding, terminally ill, impaired renal function (serum creatinine > 1.8 mg/100 ml), allergic to study drugs or penicillin, septic shock (chills, leucopaenia and haemodynamically unstable), previously established localised periappendiceal abscess. |
| Interventions |
3 regimens used:
1) Gentamicin 1.5 mg/kg (8 hourly) and clindamycin 600 mg (6 hourly).
2) Cefamandole 1.5 g (6 hourly) and placebo.
3) Cefoperazone 2.0 g (12 hourly) and placebo.
Gentamicin serum level monitored to maintain peak serum levels at 7 +/‐ 1.5 mcg/ml and trough levels below 2 mcg/ml.
Timing of antibiotic infusion: pre‐operatively.
Length: > 5 days or until patient was afebrile for 48 hours. |
| Outcomes |
Clinical success.
Wound infection, intra‐abdominal abscess and clinical sepsis.
Adverse reactions. |
| Notes |
Adverse reactions were all minor.
All patients had complicated appendicitis.Gentamicin/clindamycin regimen was statistically more effective than cephalosporin regimens alone. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Low risk |
A ‐ Adequate |
