Pediatrics/original research
Randomized, Controlled Trial of Antibiotics in the Management of Community-Acquired Skin Abscesses in the Pediatric Patient

Presented at the Pediatric Academic Society, May 2008, Honolulu, HI; and the Midwest Society of Pediatric Research, October 2008, Cleveland, OH.
https://doi.org/10.1016/j.annemergmed.2009.03.014Get rights and content

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.

Introduction

The incidence of skin and soft tissue infections has increased markedly during the last decade. From 1993 to 2005, there was nearly a 3-fold increase in skin infections diagnosed by emergency physicians in the United States, from 1.2 to 3.4 million cases.1 There are numerous reports indicating that this overall increase is primarily due to a dramatic increase in the number of infections caused by community-acquired methicillin-resistant Staphylococcus aureus (CA-MRSA), an organism that often presents with skin and soft tissue infections in the pediatric population.2, 3 In the past, surgical drainage of skin abscesses has been the accepted standard of care. With the emergence of CA-MRSA causing serious and even fatal infections in immunocompetent pediatric patients, many have recommended the addition of antibiotic therapy.3, 4, 5

Several published studies have suggested that skin abscesses can be cured with adequate drainage alone, according to the finding that many patients improve despite receiving antibiotics to which their infecting organisms are not susceptible.6, 7, 8 Rajendran et al9 reported no benefit with the addition of cephalexin to the management of surgically drained CA-MRSA skin abscesses in adult patients, but a retrospective study by Ruhe et al5 reported an association between delayed initiation of active antibiotic and treatment failure of CA-MRSA skin abscesses in adults.

To our knowledge, there are no published randomized controlled studies evaluating the benefits of antibiotic treatment of adequately drained skin abscesses in the era of CA-MRSA, either in adults or in the pediatric population.

The purpose of this study is to demonstrate noninferiority of placebo relative to antibiotic use in pediatric patients who undergo incision and drainage of acute skin abscesses.

Section snippets

Setting

This study was conducted in the emergency department (ED) at the Cardinal Glennon Children's Medical Center, Saint Louis University in St. Louis, MO, from July 2006 to February 2008. It is a Level I pediatric trauma center, with annual visits of 41,000 patients.

Selection of Participants

The study population consisted of pediatric patients aged 3 months to 18 years, who had skin abscesses and were nontoxic, with temperature less than 38.4 °C (101.1 °F). Skin abscesses were diagnosed clinically and by bedside

Characteristics of Study Subjects

A total of 1,305 patients who presented to our ED were identified with the International Classification of Disease coding for cellulitis and skin abscesses during the study period. This was not a convenience sampling. Among this group of potential study subjects were 161 individuals who agreed to participate in the trial after the protocol was reviewed with them. These subjects were then randomly assigned treatment with either placebo or trimethoprim-sulfamethoxazole. Twelve subjects were lost

Limitations

Limitations to this study include possible selection bias, with a large proportion of potential patients not being enrolled from July 24, 2006, to February 2, 2008, by the examining physician. Another source of selection bias may come from the 12 participants (7%) who were lost to follow-up, but this is a relatively small number, and analysis of available data for them indicates similarity with the studied subjects. Forty percent of our follow-ups occurred by telephone calls, which is another

Discussion

Across the nation, there has been a dramatic increase in the diagnosis of skin and soft tissue infections.1 There is no doubt that CA-MRSA has emerged as a common pathogen causing skin abscesses in adult and pediatric patients throughout the United States. Young7 reported that 63% of skin abscess cultures in adults were CA-MRSA (median age 42 years; range 1 to 89 years). Moran et al2 reported 76% CA-MRSA skin and soft tissue infections in adults, which is comparable to that in the pediatric

References (14)

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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.

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