Utility of Trimethoprim-sulfamethoxazole Use in Skin Abscess Management

Saint Louis University (SLU)

Status and phase: Completed; Phase 4

Conditions: Skin Diseases, Infectious

Treatments: Drug: Placebo group; Drug: Trimethoprim-sulfamethoxazole

Study type: Interventional

Funder types: Other

Identifiers

NCT00679302

14415

Details and patient eligibility

About

The purpose of this study is to determine if antibiotics are required in the management of skin abscess following incision and drainage.

Full description

This is a double-blind, randomized controlled trial at an urban pediatric emergency department. Sample size (162) was based on a threshold equivalence of 7% (α = 0.05, power = 80%). Inclusion criteria were: non-toxic, immunocompetent, 3 months to 18 years old, English-speaking patients with clinical or ultrasound identified skin abscesses who were not on antibiotics. Patients were block randomized to receive placebo or trimethoprim/sulfamethoxazole following incision and drainage. Follow-up was a call at 2-3 days & a repeat visit or call at 10-14 days. Treatment failure was defined as: persistent erythema, tenderness, and/or draining lesions. New lesion was defined as: primary resolution with development of new lesion (furuncle, carbuncle or abscess) at a different location. Compliance was evaluated by the return of the study medication or by patient report.

Enrollment: 161 patients

Sex: All

Ages: 3 months to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• non-toxic patients
• immunocompetent patients
• 3 months to 18 years old
• English-speaking patients
• skin abscesses
• not on antibiotics

Exclusion criteria

• toxic patients
• immunocompromising co-morbidities
• less than 3 months old or older than 18 years of age
• non-english speaking
• on antibiotics

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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161 participants in 2 patient groups, including a placebo group

placebo group

Placebo Comparator group

Description:

Maalox and bitter mixture

Treatment:

Drug: Placebo group

antibiotic group

Active Comparator group

Description:

Trimethoprim-sulfamethoxazole suspension

Treatment:

Drug: Trimethoprim-sulfamethoxazole