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Management of Skin and Soft Tissue Abscesses in Pediatric Patients After Incision and Drainage

Information source: Baylor College of Medicine
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Abscess

Intervention: oral trimethoprim/sulfamethoxazole (Drug); Placebo (Drug); Observational Unit Short Stay (Other); Hospitalization (Other)

Phase: Phase 3

Status: Completed

Sponsored by: Baylor College of Medicine


The purpose of this study is to compare successful rates of cure of abscesses less than 5 cm with antibiotic versus non-antibiotic treatment after incision and drainage. We will also compare successful rates of cure and time to healing with IV antibiotics and 23-hour observation unit stay versus hospitalization with IV antibiotics for abscesses greater than 5 cm but less than 10 cm in pediatric patients.

Clinical Details

Official title: Phase 3 Study Comparing Bactrim to Placebo in the Management of Abscesses < 5cm and 23 hr Observation Unit to Inpatient Treatment in the Management of Abscesses 5-10cm in the Pediatric Population.

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Proportion of patients having abscess resolution to those that do not for each of the treatment modalities employed. For the < 5 cm arm, compare the proportions of patients with successful outcomes between the placebo and TMP/SMX groups.

Secondary outcome: The 5 - 10 cm arm, will compare the proportions of patients with successful outcomes between the 23-hour observation and hospitalization groups.


Minimum age: 90 Days. Maximum age: 18 Years. Gender(s): Both.


Inclusion Criteria:

- Fluctuant abscess on trunk, scalp, extremities and axilla.

Exclusion Criteria:

- Multiple abscesses

- Abscesses greater than 10 cm

- Abscesses located on the hands, face, and perineum

- Bite wounds

- Immunocompromised patients (including diabetes, sickle cell, chronic steroid therapy,


- Previously failed 48 hours or greater therapy on any antibiotic regimen

- Abscess less than 5 cm AND patient has (for exclusion criteria 7 - 10):

- Drug allergy to TMP/SMX

- Fever greater than or equal to 102. 2 degrees F in last 24 hours

- Systemic symptoms on presentation - i. e., nausea, vomiting, diaphoresis, etc. \

- Signs/symptoms of another infection or illness - i. e., influenza, croup, etc. Abscess

5 - 10 cm AND patient has (for exclusion criterion 11): \

- Drug allergy to both Clindamycin AND Vancomycin

Locations and Contacts

Texas Children's Hospital, Houston, Texas 77030, United States
Additional Information

Starting date: December 2007
Last updated: December 2, 2010

Page last updated: August 23, 2015

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