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  • Antibiotic prophylaxis for ED patients with simple hand lacerations: a feasibility randomized controlled trial.

Antibiotic prophylaxis for ED patients with simple hand lacerations: a feasibility randomized controlled trial.

The American journal of emergency medicine (2014-05-06)
Nicole Berwald, Feras Khan, Shahriar Zehtabchi
ABSTRACT

The benefit of antibiotic prophylaxis for simple hand lacerations (lacerations that do not involve special structures) has not been adequately studied. To assess the feasibility of a randomized controlled trial to determine the role of antibiotic prophylaxis in emergency department (ED) patients with simple hand lacerations. Randomized, double-blind, placebo-controlled pilot trial in 2 urban academic EDs. Adult (≥18 years old) patients with simple hand lacerations were randomized to cephalexin, 500 mg; clindamycin, 300 mg; or placebo (every 6 hours for 7 days, all in identical capsules). (1) feasibility determined by the number of patients who agreed to enroll and number of patients who completed follow-up, (2) infection rate (determined by 2 physicians at 10-14 days), (3) satisfaction with wound appearance (measured by a visual analogue scale at 30 days via phone). Medians, quartiles, and percentages with 95% confidence intervals (CI) were used to present data. Groups were compared with Kruskal-Wallis and Fisher exact tests, when appropriate. Over a 5-month period, 123 patients were approached, and 78 consented to enrollment (63%; 95% CI, 55-71%). Five were lost to follow-up (5/78, 6%; 95% CI, 2%-14%). Only one patient had infection on follow-up for an infection rate of 1% (95% CI, 0.01%-8%). Patient's satisfaction with wound appearance did not differ among the groups. The findings of this pilot study support the feasibility of a randomized, double-blind, controlled trial. The low rate of infection suggests the need of a large sample size for the trial.

MATERIALS
Product Number
Brand
Product Description

Sigma-Aldrich
Cephalexin hydrate, first-generation cephalosporin antibiotic
Cephalexin monohydrate, European Pharmacopoeia (EP) Reference Standard
Sigma-Aldrich
Clindamycin hydrochloride, lincosamide antibiotic
Supelco
Cefalexin, VETRANAL®, analytical standard
USP
Cephalexin, United States Pharmacopeia (USP) Reference Standard
USP
Clindamycin hydrochloride, United States Pharmacopeia (USP) Reference Standard
Supelco
Clindamycin hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material
Clindamycin hydrochloride, European Pharmacopoeia (EP) Reference Standard