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Randomized Controlled Trial Multicenter Study
Antibiotic prophylaxis for ED patients with simple hand lacerations: a feasibility randomized controlled trial.
- Nicole Berwald, Feras Khan, and Shahriar Zehtabchi.
- Department of Emergency Medicine, Staten Island University Hospital, Staten Island, NY. Electronic address: nicole.berwald@gmail.com.
- Am J Emerg Med. 2014 Jul 1;32(7):768-71.
BackgroundThe benefit of antibiotic prophylaxis for simple hand lacerations (lacerations that do not involve special structures) has not been adequately studied.ObjectiveTo assess the feasibility of a randomized controlled trial to determine the role of antibiotic prophylaxis in emergency department (ED) patients with simple hand lacerations.MethodsRandomized, 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).Outcomes(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.ResultsOver 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.ConclusionThe 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.Copyright © 2014 Elsevier Inc. All rights reserved.
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