Utility of Trimethoprim-sulfamethoxazole Use in Skin Abscess Management

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if antibiotics are required in the management of skin abscess following incision and drainage.

Detailed 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.

Official Title
-----------------
A Double Blinded Randomized Controlled Trial for the Management of Pediatric Community Acquired Skin Abscesses - To Treat or Not to Treat With Antibiotics

Conditions
-----------------
Skin Diseases, Infectious

Intervention / Treatment
-----------------
* Drug: Trimethoprim-sulfamethoxazole
* Drug: Placebo group


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 3 Months
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo group<br>Maalox and bitter mixture | Drug: Placebo group<br>* Placebo (Maalox with simethicone and bitter mixture) suspension was dispensed to study participants who were block randomized to receive the placebo.<br>* Other names: Maalox (with simethicone and bitter mixture);|
| Active Comparator: antibiotic group<br>Trimethoprim-sulfamethoxazole suspension | Drug: Trimethoprim-sulfamethoxazole<br>* Participants were randomized to receive placebo or trimethoprim/sulfamethoxazole using a computer randomization program on the initial presentation. The placebo is a Maalox and tonic water combination that resembled the antibiotic in color, texture and taste. The antibiotic dose is a standard trimethoprim/sulfamethoxazole for bacterial infection (10-12mg trimethoprim/kg/day, with a maximum adult dose of 160mg trimethoprim/day, divided into two doses). The concentration of the liquid is 200mg sulfamethoxazole/40mg trimethoprim per 5mL. With a maximum dose of 160mg trimethoprim, this equates to 20mL.<br>* Other names: Septra;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin Abscess Resolution |  | 10-14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| New Lesion Development and Spread of Skin Abscesses (on Subject) | The secondary outcomes of interest included the development of new lesions at a different site (>5cm away from original skin abscess) on day 10 clinical follow-up or self-report and 3 month telephone follow-up. | 10-14 days and 3 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
skin abscess, CA-MRSA