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

This study has been completed.
Sponsor:
Information provided by:
Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00691600
First received: December 28, 2007
Last updated: December 2, 2010
Last verified: December 2010
  Purpose

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.


Condition Intervention Phase
Abscess
Drug: oral trimethoprim/sulfamethoxazole
Drug: Placebo
Other: Observational Unit Short Stay
Other: Hospitalization
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • 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. [ Time Frame: 3yrs ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The 5 - 10 cm arm, will compare the proportions of patients with successful outcomes between the 23-hour observation and hospitalization groups. [ Time Frame: 3yrs ] [ Designated as safety issue: No ]

Estimated Enrollment: 472
Study Start Date: December 2007
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: TMP/SMX vs Placebo
subjects with abscesses less than 5cm will be randomized to either study med or placebo
Drug: oral trimethoprim/sulfamethoxazole
80 mg caps or 8 mg/ml suspension every 12 hours for 10 days
Other Name: Bactrim
Drug: Placebo
Placebo caps or suspension every 12 hours for 10 days
Hospitalization vs. 23 HR OBS Unit
Patients with abscesses 5-10cm will be randomized to either inpatient stay or 23 hour short stay in the observation unit.
Other: Observational Unit Short Stay
Patients with abscesses greater that 5cm to 10cm randomized to Observational Short Stay unit for up to 23 hrs.
Other: Hospitalization
Patients with abscesses 5-10cm may be randomized to inpatient treatment

  Eligibility

Ages Eligible for Study:   90 Days to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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, etc.)
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00691600

Locations
United States, Texas
Texas Children's Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
  More Information

No publications provided

Responsible Party: Charles Macias, MD, MPH, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00691600     History of Changes
Other Study ID Numbers: H-18758
Study First Received: December 28, 2007
Last Updated: December 2, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:
abscess
Abscesses in the pediatric emergency population

Additional relevant MeSH terms:
Abscess
Suppuration
Infection
Inflammation
Pathologic Processes
Sulfamethoxazole
Trimethoprim
Trimethoprim-Sulfamethoxazole Combination
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Infective Agents, Urinary
Renal Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 23, 2014