Utility of Trimethoprim-sulfamethoxazole Use in Skin Abscess Management

Overview

The purpose of this study is to determine if antibiotics are required in the management of skin abscess following incision and drainage.

Full Title of Study: “A Double Blinded Randomized Controlled Trial for the Management of Pediatric Community Acquired Skin Abscesses – To Treat or Not to Treat With Antibiotics”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: February 2008

Detailed Description

This is a double-blind, randomized controlled trial at an urban pediatric emergency department. Sample size (162) was based on a threshold equivalence of 7% (α = 0.05, power = 80%). Inclusion criteria were: non-toxic, immunocompetent, 3 months to 18 years old, English-speaking patients with clinical or ultrasound identified skin abscesses who were not on antibiotics. Patients were block randomized to receive placebo or trimethoprim/sulfamethoxazole following incision and drainage. Follow-up was a call at 2-3 days & a repeat visit or call at 10-14 days. Treatment failure was defined as: persistent erythema, tenderness, and/or draining lesions. New lesion was defined as: primary resolution with development of new lesion (furuncle, carbuncle or abscess) at a different location. Compliance was evaluated by the return of the study medication or by patient report.

Interventions

  • Drug: Trimethoprim-sulfamethoxazole
    • Participants were randomized to receive placebo or trimethoprim/sulfamethoxazole using a computer randomization program on the initial presentation. The placebo is a Maalox and tonic water combination that resembled the antibiotic in color, texture and taste. The antibiotic dose is a standard trimethoprim/sulfamethoxazole for bacterial infection (10-12mg trimethoprim/kg/day, with a maximum adult dose of 160mg trimethoprim/day, divided into two doses). The concentration of the liquid is 200mg sulfamethoxazole/40mg trimethoprim per 5mL. With a maximum dose of 160mg trimethoprim, this equates to 20mL.
  • Drug: Placebo group
    • Placebo (Maalox with simethicone and bitter mixture) suspension was dispensed to study participants who were block randomized to receive the placebo.

Arms, Groups and Cohorts

  • Placebo Comparator: placebo group
    • Maalox and bitter mixture
  • Active Comparator: antibiotic group
    • Trimethoprim-sulfamethoxazole suspension

Clinical Trial Outcome Measures

Primary Measures

  • Skin Abscess Resolution
    • Time Frame: 10-14 days

Secondary Measures

  • New Lesion Development and Spread of Skin Abscesses (on Subject)
    • Time Frame: 10-14 days and 3 month
    • The secondary outcomes of interest included the development of new lesions at a different site (>5cm away from original skin abscess) on day 10 clinical follow-up or self-report and 3 month telephone follow-up.

Participating in This Clinical Trial

Inclusion Criteria

  • non-toxic patients – immunocompetent patients – 3 months to 18 years old – English-speaking patients – skin abscesses – not on antibiotics Exclusion Criteria:

  • toxic patients – immunocompromising co-morbidities – less than 3 months old or older than 18 years of age – non-english speaking – on antibiotics

Gender Eligibility: All

Minimum Age: 3 Months

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • St. Louis University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • John Peter, MD, Study Director, St. Louis University

References

Pallin DJ, Egan DJ, Pelletier AJ, Espinola JA, Hooper DC, Camargo CA Jr. Increased US emergency department visits for skin and soft tissue infections, and changes in antibiotic choices, during the emergence of community-associated methicillin-resistant Staphylococcus aureus. Ann Emerg Med. 2008 Mar;51(3):291-8. doi: 10.1016/j.annemergmed.2007.12.004. Epub 2008 Jan 28.

Korownyk C, Allan GM. Evidence-based approach to abscess management. Can Fam Physician. 2007 Oct;53(10):1680-4.

Cohen PR. Community-acquired methicillin-resistant Staphylococcus aureus skin infections: implications for patients and practitioners. Am J Clin Dermatol. 2007;8(5):259-70. doi: 10.2165/00128071-200708050-00001.

Lee MC, Rios AM, Aten MF, Mejias A, Cavuoti D, McCracken GH Jr, Hardy RD. Management and outcome of children with skin and soft tissue abscesses caused by community-acquired methicillin-resistant Staphylococcus aureus. Pediatr Infect Dis J. 2004 Feb;23(2):123-7. doi: 10.1097/01.inf.0000109288.06912.21.

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