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

Baylor College of Medicine

Status and phase: Completed; Phase 3

Conditions: Abscess

Treatments: Drug: Placebo; Drug: oral trimethoprim/sulfamethoxazole

Study type: Interventional

Funder types: Other

Identifiers

NCT00691600

H-18758

Details and patient eligibility

About

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.

Full 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)

Enrollment: 23 patients

Sex: All

Ages: 90 days to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

---

23 participants in 2 patient groups, including a placebo group

oral trimethoprim/sulfamethoxazole

Active Comparator group

Description:

subjects with abscesses less than 5cm will be randomized to either study med or placebo

Treatment:

Drug: oral trimethoprim/sulfamethoxazole

placebo

Placebo Comparator group

Description:

Placebo after incision and drainage of abscess less than 5 cm.

Treatment:

Drug: Placebo