Author, date and country | Patient group | Study type (level of evidence) | Outcomes | Key results | Study Weaknesses |
---|---|---|---|---|---|
Stevenson et al, 2003, UK | 193 patients >16 years old with an open fracture of the distal phalanx Randomised to placebo or flucloxacillin 500mg qds for 5 days, with all receiving wound toilet and tissue repair Excluded closed subungual haematoma & fracture, but include trephined subungual haematoma & fracture Exclusion criteria were wounds >12 hours old, Hx of diabetes, oral steroid therapy, fractures cause by a bite, those on an antibiotic, allergy to penicillin | Randomised controlled trial, single blinded | Infection rate in each group (review carried out at 4 or 5 days, 14 days and 8 weeks) | Non-significant difference in infection rates as measured by a difference in proportion test between the two groups (P>0.05). 4% in placebo group, 3% in antibiotic group. 84% overall compliance rate with flucloxacillin | Strengths included a pilot study to allow an accurate power calculation, as well as analysis on an intention to treat basis |
Altergott et al, 2008, USA | 146 patients < 18 years old with injuries distal to DIPJ classified into damage to nailbed requiring repair, simple laceration, loss of skin or pulp, partial amputation, full amputation Patients randomized to no antibiotic or cephalexin 50mg/kg divided tds for 7 days, with all receiving wound toilet and tissue repair Exclusion criteria were wounds > 8 hours old, gross contamination, immune deficiency, diabetes, steroid therapy, oncological disorder, allergy to cephalosporins, or those on an antibiotic | Randomised trial, single blinded non inferiority | Infection rate in each group (review carried out at 7 days) | No statistical difference in infection rate between the no antibiotic group 1.45% (95% CI 0.04% - 7.81%) versus 1.52% (95% CI 0.04% - 8.16%) in the antibiotic group. Upper limit of a 1 sided 95% CI for the difference in rates was 4.9% (suggesting that the infection rate in the no antibiotic group would not exceed that of the antibiotic group by more than 4.9%). | Power calculation was a pragmatic combination of the numbers researchers expected to be able to recruit combined with a power calculation No true randomization Study terminated early due to staffing issues 11 subjects withdrew – no intention to treat analysis Infection rates too low to allow inter-group analysis |
Sloan et al, 1987, UK | 85 adults presenting with recent (<6 h) open fractures of distal phalanges | Controlled clinical trial comparing no antibiotics with three different antibiotic regimes | Infection rate | Three out of 10 patients who received no antibiotics developed infection compared with a total of two out of 75 patients who had received antibiotic | Small numbers. No randomisation or randomisation not described. Stopped recruiting patients to no antibiotic group as felt unethical due to high infection rate. Unblinded. Describes variable wound severity but no description of severity of injuries in each of the groups |
Suprock et al, 1990, USA | 91 patients with open fractures of the finger. Surgical irrigation and debridement with or without antibiotics | Controlled clinical trial | Infection rate | Four patients in each group developed infection | Quasi-randomisation technique (alternate days). No blinding |