Author, date and country | Patient group | Study type (level of evidence) | Outcomes | Key results | Study Weaknesses |
---|---|---|---|---|---|
Stevenson J et al 2003 UK | 193 adult patients (without diabetes, steroid treatment or peripheral vascular disease) with an open fracture of the distal phalanx All wounds were thoroughly irrigated and debrided. 98 patients received antibiotics (flucloxacillin po) and the remaining 95 were in the placebo group | Double-blind, prospective, randomised placebo-controlled clinical trial Level 1b | Follow up rates: Day4/5; Day 14; 8 weeks | 100% follow up at day 4/5; 91% follow up at day 14; 67% follow up at 8 weeks | |
Compliance | 84% compliant in antibiotic group; 91% compliant in placebo group | ||||
Infection rate | 3% (3/98 patients) developed superficial infection in the antibiotic group; 4% (4/95 patients) in the placebo group; Overall 4% (7/193 patients) infection rate; A difference of proportion test confirmed no significant difference; No patients developed deep wound infection or osteitis | ||||
Positive bacterial swab | 86% (6/7) of infections grew Staphylococcus aureus; 1/7 (14%) grew E.Coli, coliforms and enterococcus | ||||
Suprock MD et al 1990 USA | 91 patients with open fractures of the finger Aggressive surgical irrigation and debridement with 45 patients receiving antibiotics and the remaining 46 in the control group | Prospective randomised controlled clinical trial Level 2a | Number of infections | 9% (4 patients) in each group developed clinical signs of infection; None developed osteomyelitis | Small numbers Not double blind trial No exclusion criteria - patients with underlying diseases such as Diabetes or peripheral vascular disease were included |
Positive bacterial swab | 2.1% (2/91 patients) had cultures that grew Staphylococcus aureus | ||||
Sloan JP et al, 1986, UK3 1986 UK | 85 adult patients with open fractures of the distal phalanx (<6 hours) treated by conventional surgery. Patients were randomised to one of four treatment regimes: 1. No antibiotics 2. Cephradine 500mg PO QDS for 5 days 3. Cephradine 1gm pre-operatively and then 500mg PO QDS for 5 days 4. Cephradine 1gm IV pre-operatively and then 1 gm post-operatively | Prospective randomised controlled clinical trial Level 2a | Signs of infection | Group 1 (no antibiotics) was discontinued after first 40 patients. 30% (3/10 patients) developed infection - felt unethical to continue; no significant difference in the infection rate between Groups 2-4 with differing regimes of antibiotic treatment; overall infection rate 4.7%; no patient developed osteomyelitis | Small numbers Not double blind study No long term follow up (only Day 2 & 5) |
Positive bacterial swab | 4/85 (5%) developed bacteriologically proven infections; 75% grew Staphylococcus aureus and 25% grew viridans-type streptococcus |