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Utility of Trimethoprim-sulfamethoxazole Use in Skin Abscess Management

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00679302
Recruitment Status : Completed
First Posted : May 16, 2008
Results First Posted : April 29, 2014
Last Update Posted : May 4, 2018
Information provided by (Responsible Party):
St. Louis University

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

Condition or disease Intervention/treatment Phase
Skin Diseases, Infectious Drug: Trimethoprim-sulfamethoxazole Drug: Placebo group Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 161 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double Blinded Randomized Controlled Trial for the Management of Pediatric Community Acquired Skin Abscesses - To Treat or Not to Treat With Antibiotics
Study Start Date : July 2006
Actual Primary Completion Date : February 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: placebo group
Maalox and bitter mixture
Drug: Placebo group
Placebo (Maalox with simethicone and bitter mixture) suspension was dispensed to study participants who were block randomized to receive the placebo.
Other Name: Maalox (with simethicone and bitter mixture)

Active Comparator: antibiotic group
Trimethoprim-sulfamethoxazole suspension
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.
Other Name: Septra

Primary Outcome Measures :
  1. Skin Abscess Resolution [ Time Frame: 10-14 days ]

Secondary Outcome Measures :
  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.

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Ages Eligible for Study:   3 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00679302

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United States, Missouri
Cardinal Glennon Children's Medical Center
Saint Louis, Missouri, United States, 63104
Sponsors and Collaborators
St. Louis University
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Study Director: John Peter, MD St. Louis University
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: St. Louis University Identifier: NCT00679302    
Other Study ID Numbers: 14415
First Posted: May 16, 2008    Key Record Dates
Results First Posted: April 29, 2014
Last Update Posted: May 4, 2018
Last Verified: March 2014
Keywords provided by St. Louis University:
skin abscess
Additional relevant MeSH terms:
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Communicable Diseases
Skin Diseases, Infectious
Skin Diseases
Disease Attributes
Pathologic Processes
Trimethoprim, Sulfamethoxazole Drug Combination
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Antiprotozoal Agents
Antiparasitic Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Cytochrome P-450 CYP2C8 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Antifoaming Agents
Dermatologic Agents
Anti-Bacterial Agents