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

Phase 3

Completed

Conditions: Abscess

Interventions: Drug: oral trimethoprim/sulfamethoxazole
Drug: Placebo

Registration Number: NCT00691600

Lead Sponsor: Baylor College of Medicine

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.

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)

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 23

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
oral trimethoprim/sulfamethoxazole	oral trimethoprim/sulfamethoxazole	subjects with abscesses less than 5cm will be randomized to either study med or placebo
placebo	Placebo	Placebo after incision and drainage of abscess less than 5 cm.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Abscess Resolution	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

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