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Completed

NCT Number: NCT00679302

Utility of Trimethoprim-sulfamethoxazole Use in Skin Abscess Management

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

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Key information

Conditions

Skin Diseases, Infectious Infections Skin Diseases Skin and Connective Tissue Diseases

Age range

3 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cardinal Glennon Children's Medical Center

St Louis, Missouri, 63104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trimethoprim-sulfamethoxazole

Drug

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.

Other names: Septra

Placebo Group

Drug

Placebo (Maalox with simethicone and bitter mixture) suspension was dispensed to study participants who were block randomized to receive the placebo.

Other names: Maalox (with simethicone and bitter mixture)

Primary outcomes

  1. Skin Abscess Resolution

    Time frame: 10-14 days

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

St. Louis University

Other

Registry information

Official study title

A Double Blinded Randomized Controlled Trial for the Management of Pediatric Community Acquired Skin Abscesses - To Treat or Not to Treat With Antibiotics

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
May 16, 2008
Registry last updated
May 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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