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

Study Overview
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Brief Summary
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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.

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

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

Conditions
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Abscess

Intervention / Treatment
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* Drug: oral trimethoprim/sulfamethoxazole
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 90 Days
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: oral trimethoprim/sulfamethoxazole<br>subjects with abscesses less than 5cm will be randomized to either study med or placebo | Drug: oral trimethoprim/sulfamethoxazole<br>* 80 mg caps or 8 mg/ml suspension every 12 hours for 10 days<br>* Other names: TMP/SMX;|
| Placebo Comparator: placebo<br>Placebo after incision and drainage of abscess less than 5 cm. | Drug: Placebo<br>* Placebo caps or suspension every 12 hours for 10 days<br>* Other names: Placebo caps;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Abscess Resolution | 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 | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Requiring Admission for Failure of Abscess Resolution | Percentage of patients requiring admission to Texas Children's or another hospital within 10 days of incision and drainage | 10 days | 
| Number of Participants Requiring New or Modified Antibiotics for Failure of Abscess to Resolve | 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 | 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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abscess, Abscesses in the pediatric emergency population