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Completed

NCT Number: NCT00691600

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

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.

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Key information

Age range

90 day–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Texas Children's Hospital

Houston, Texas, 77030, United States

About this study

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:

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

Secondary outcomes:

  • Admission to the hospital because of worsening infection
  • Receipt of antibiotics (placebo arm) or change in antibiotics (antibiotic arm)

Who can participate

Healthy volunteers accepted: No

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

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

  • Multiple abscesses
  • Abscess located on the hands, face, or perineum
  • Abscess as a result of a bite wound
  • Immunocompromised patient - i.e., diabetes, sickle cell, chronic steroid therapy (> 10 days), etc.
  • 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.

Treatment and study plan

oral trimethoprim/sulfamethoxazole

Drug

80 mg caps or 8 mg/ml suspension every 12 hours for 10 days

Other names: TMP/SMX

Placebo

Drug

Placebo caps or suspension every 12 hours for 10 days

Other names: Placebo caps

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Registry information

Official study title

Phase 3 Study Comparing Bactrim to Placebo in the Management of Abscesses < 5cm in the Pediatric Population.

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Jun 5, 2008
Registry last updated
Jul 1, 2020

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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