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

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.
 
ClinicalTrials.gov Identifier: NCT00691600
Recruitment Status : Completed
First Posted : June 5, 2008
Results First Posted : June 23, 2020
Last Update Posted : July 1, 2020
Sponsor:
Information provided by (Responsible Party):
Andrea Cruz, Baylor College of Medicine

Study Description
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Brief Summary:
The purpose of the study is to compare rates of cure of abscesses with and without antibiotic treatment after incision and drainage. The purpose of this study is to compare successful rates of cure of abscesses less than 5 cm with antibiotic (oral TMP/SMX) versus non-antibiotic treatment after incision and drainage.

Condition or disease Intervention/treatment Phase
Abscess Drug: oral trimethoprim/sulfamethoxazole Drug: Placebo Phase 3

Detailed Description:

This study is a randomized controlled trial of antibiotic treatment versus placebo after incision and drainage of skin and soft tissue abscesses less than 5 cm in pediatric patients. Eligible patients whose parents/guardians consented them to enrollment were randomized to receive one of two interventions: oral trimethoprim/sulfamethoxazole (TMP/SMX) or placebo after incision and drainage. Every attempt was made to make the placebo capsules and suspensions appear in all aspects like the true drug (was done by the investigational pharmacy department at our institution). Equal numbers of subjects were randomized at the outset to both study groups. Randomization, also done by our investigational pharmacy department, was done in blocks of 20. Patients were followed up in our emergency center at 24 to 48 hours to have any packing removed and to have their clinical/wound status assessed. They were not charged for this visit, and their valet parking was validated. If an individual patient, or an individual patient's wound, was felt to be not improving adequately, that patient was started on formal antibiotic therapy at the treating attending physician's discretion.

Primary outcome:

1. Abscess resolution by parental report 7-10 days after incision and drainage

Secondary outcomes:

  1. Admission to the hospital because of worsening infection
  2. Receipt of antibiotics (placebo arm) or change in antibiotics (antibiotic arm)
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 3 Study Comparing Bactrim to Placebo in the Management of Abscesses < 5cm in the Pediatric Population.
Study Start Date : December 2007
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abscess

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: oral trimethoprim/sulfamethoxazole
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: TMP/SMX
Placebo Comparator: placebo
Placebo after incision and drainage of abscess less than 5 cm.
 Drug: Placebo
Placebo caps or suspension every 12 hours for 10 days
Other Name: Placebo caps


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Abscess Resolution [ Time Frame: 10 days ]
    Outcomes will be measured by resolution of size, tenderness, and induration with erythema by parental report 7 - 10 days after initial visit to the Emergency Center


Secondary Outcome Measures :
  1. Number of Participants Requiring Admission for Failure of Abscess Resolution [ Time Frame: 10 days ]
    Percentage of patients requiring admission to Texas Children's or another hospital within 10 days of incision and drainage

  2. Number of Participants Requiring New or Modified Antibiotics for Failure of Abscess to Resolve [ Time Frame: 10 days ]

    For the antibiotic arm, we determined if the child was prescribed a different antibiotic.

    For the placebo arm, we determined if the child received a prescription for an antibiotic at a subsequent visit (e.g., in the emergency department, by their pediatrician, etc) within 10 days of incision and drainage



Eligibility Criteria
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Ages Eligible for Study:   90 Days to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1.) Abscess < 5 cm (< 5 cm of induration and fluctuance) requiring incision and drainage 2.) Age > 90 days and < 18 years 3.) Abscess on the trunk, scalp, extremities, or axillae

Exclusion Criteria:

  1. Multiple abscesses
  2. Abscess located on the hands, face, or perineum
  3. Abscess as a result of a bite wound
  4. Immunocompromised patient - i.e., diabetes, sickle cell, chronic steroid therapy (> 10 days), etc.
  5. Previously failed 48 hours or greater therapy on any antibiotic regimen 6.) Drug allergy to TMP/SMX

7.) Fever > or = 102.2 degrees Fahrenheit in the previous 24 hours 8.) Systemic symptoms on presentation - i.e., nausea , vomiting, persistent tachycardia, hypotension, diaphoresis, etc.

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

Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00691600


Locations
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United States, Texas
Texas Children's Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Investigators
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Principal Investigator: Andrea Cruz, MD, MPH Baylor College of Medicine
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Andrea Cruz, Principal Investigator, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00691600    
Other Study ID Numbers: H-18758
First Posted: June 5, 2008    Key Record Dates
Results First Posted: June 23, 2020
Last Update Posted: July 1, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Andrea Cruz, Baylor College of Medicine:
abscess
Abscesses in the pediatric emergency population
Additional relevant MeSH terms:
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Abscess
Suppuration
Infections
Inflammation
Pathologic Processes
Trimethoprim
Sulfamethoxazole
Anti-Infective Agents, Urinary
Anti-Infective Agents
 Antimalarials
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