Antibiotic Therapy After Incision and Drainage for Abscess

Study Overview
=================
Brief Summary
-----------------
Background: Skin abscesses are a growing problem in the general pediatric population around the world. While the standard treatment for an abscess/boil is incision and drainage, many physicians also prescribe antibiotics, despite the lack of evidence that antibiotics are necessary to help the wound heal. The purpose of this research study is to determine whether antibiotics are necessary after incision and drainage of a skin abscess in children. This is an important question because medical evidence has shown that using antibiotics when they are not needed has contributed to the increase of bacterial antibiotic resistance. In fact, several of the antibiotics that successfully killed Staph bacteria several years ago are now no longer effective because of antibiotic resistance. Now resistant forms of Staph bacteria, called Community-Acquired Methicillin-Resistant Staph Aureus (CA-MRSA), account for 50-85% of all pediatric skin abscesses. If antibiotics are not necessary then withholding them when appropriate may help slow the progression of antibiotic-resistant Staph infections. Objective(s) and Hypothesis(es): The investigators believe that antibiotics are no better than placebo at achieving a cure after drainage of an abscess in a child. The objective of this study is to answer the question: Do antibiotics after abscess drainage result in a better chance of cure than placebo? Potential Impact: If abscess drainage alone is shown to be as effective as drainage followed by antibiotics, then the routine use of antibiotics for this problem could be avoided. This would help limit the increasing antibiotic resistance of bacteria (especially CA-MRSA) in communities around the world. A well-designed study may provide the evidence to change the way children are treated for abscesses in a future where antibiotic resistant bacteria will be even more of a public health challenge.

Official Title
-----------------
The Use of Adjuvant Antibiotic Therapy After Incision and Drainage for Pediatric Abscess: A Prospective, Randomized, Double-blinded, Placebo-Controlled Trial

Conditions
-----------------
Abscess

Intervention / Treatment
-----------------
* Procedure: Incision and drainage
* Drug: Trimethoprim/Sulfamethoxazole (Bactrim)
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any child (age 6 months-18 years old) that: does not meet criteria for hospitalization and has only one localized abscess (>/= 2 cm of erythema and induration), which is clinically judged to be amenable to incision and drainage. (i.e., on clinical exam their is fluctuance, erythema, induration, and/or purulent drainage) has an abscess that is ± 7 days from onset, who requires surgical incision and drainage for a skin and soft-tissue abscess Exclusion Criteria: children < 6 months of age children who require inpatient hospitalization - children with a medical condition in which adjuvant antibiotic therapy would be accepted standard of practice (i.e., history of neutropenia, cardiac surgery, indwelling prosthesis) children with a previously diagnosed immunodeficiency (HIV, Chronic Granulomatous Disease, Job's syndrome, chronic steroid use) children hospitalized within 2 months of presentation (due to higher rate of nosocomial MRSA colonization) abcesses located on the head or neck children with history of a sulfa allergy abscesses caused by animal bite wounds children with Diabetes Mellitus abscesses arising from tattooing abscesses arising from vaccination sites pregnant females

Ages Eligible for Study
-----------------
Minimum Age: 6 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 |
| --- | --- |
| Experimental: Drainage and placebo<br>Incision and drainage with placebo. | Procedure: Incision and drainage<br> <br> Drug: Placebo<br> <br> |
| Active Comparator: Drainage with TMP/SX<br>Drainage with Bactrim | Drug: Trimethoprim/Sulfamethoxazole (Bactrim)<br>* Trimethoprim/Sulfamethoxazole, oral<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of abscess |  | 5-7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
subcutaneous abscess, Incision and drainage, Methicillin-resistant staphylococcus aureus