Randomized, Controlled Trial of Antibiotics in the Management of Community-Acquired Skin Abscesses in the Pediatric Patient
Study objective
Emergency department visits for skin and soft tissue infections are increasing with the discovery of community-acquired methicillin-resistant Staphylococcus aureus. Whether abscesses treated surgically also require antibiotics is controversial. There are no published pediatric randomized controlled trials evaluating the need for antibiotics in skin abscess management. We determine the benefits of antibiotics in surgically managed pediatric skin abscesses.
Methods
This was a double-blind, randomized, controlled trial. Pediatric patients were randomized to receive 10 days of placebo or trimethoprim-sulfamethoxazole after incision and draining. Follow-up consisted of a visit/call at 10 to 14 days and a call at 90 days. Primary outcome was treatment failure at the 10-day follow-up. Secondary outcome was new lesion development at the 10- and 90-day follow-ups. Noninferiority of placebo relative to trimethoprim-sulfamethoxazole for primary and secondary outcomes was assessed.
Results
One hundred sixty-one patients were enrolled, with 12 lost to follow-up. The failure rates were 5.3% (n=4/76) and 4.1% (n=3/73) in the placebo and antibiotic groups, respectively, yielding a difference of 1.2%, with a 1-sided 95% confidence interval (CI) (−∞ to 6.8%). Noninferiority was established with an equivalence threshold of 7%. New lesions occurred at the 10-day follow-up: 19 on placebo (26.4%) and 9 on antibiotics (12.9%), yielding a difference of 13.5%, with 95% 1-sided CI (−∞ to 24.3%). At the 3-month follow-up, 15 of 52 (28.8%) in the placebo group and 13 of 46 (28.3%) in the antibiotic group developed new lesions. The difference was 0.5%, with 95% 1-sided CI (−∞ to 15.6%).
Conclusion
Antibiotics are not required for pediatric skin abscess resolution. Antibiotics may help prevent new lesions in the short term, but further studies are required.
Supervising editor: Michael W. Shannon, MD; Steven M. Green, MD
Author contributions: MD was the primary investigator and corresponding author. JP and SB designed the study. JP was involved in patient recruitment. SM conducted statistical analysis and provided graphical assistance. SB provided pediatric infectious disease expertise, with significant input in data analysis and article revision. MD takes responsibility for the paper as a whole.
Funding and support: By Annals policy, all authors are required to disclose any and all commercial, financial, and other relationships in any way related to the subject of this article that might create any potential conflict of interest. See the Manuscript Submission Agreement in this issue for examples of specific conflicts covered by this statement. The authors were supported by a Fleur de Lis Award (intramural funding). This clinical trial was registered with the ClinicalTrials.gov Protocol Registration System. The registration/ID number is NCT00679302.
Dr. Duong is currently affiliated with Southern Illinois University, School of Medicine at St. John's Hospital, Springfield, IL.
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Please see page 402 for the Editor's Capsule Summary of this article.
Publication date: Available online April 30, 2009.
PII: S0196-0644(09)00270-4
doi:10.1016/j.annemergmed.2009.03.014
© 2009 American College of Emergency Physicians. Published by Elsevier Inc. All rights reserved.
Refers to article:
- Are We Looking for Superiority, Equivalence, or Noninferiority? Asking the Right Question and Answering It Correctly , 22 February 2010
- Lack of Antibiotic Efficacy for Simple Abscesses: Have Matters Come to a Head? , 29 March 2010
