Evaluation of 3 Versus 10 Days of Antibiotics in Skin Abscesses After Surgical Drainage

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to determine if there is a difference in treatment failures and recurrent skin infections when patients are given 3 or 10 days of antibiotics for uncomplicated skin abscesses after they have been surgically drained.

Detailed Description
-----------------
Patients age 3 months to 17 years presenting to a pediatric Emergency Department (ED) with an uncomplicated skin abscess that required surgical drainage were randomized to receive 3 or 10 days of oral trimethoprim-sulfamethoxazole. Patients were evaluated 10 to 14 days later to assess for cure. Patients were contacted 1 month later to determine if they had developed another skin infection. Outcomes were also stratified by methicillin-resistent staphylococcus aureus (MRSA) and methicillin-sensitive staphylococcus aureus (MSSA).

Official Title
-----------------
Randomized Non-inferiority Trial of 3 Versus 10 Days of Trimethoprim-Sulfamethoxazole in Community-Associated Skin Abscesses After Surgical Drainage

Conditions
-----------------
Skin Disease, Bacterial, Abscess

Intervention / Treatment
-----------------
* Drug: Trimethoprim-Sulfamethoxazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients presenting with a skin abscess that requires surgical drainage (induration ≥ 1 cm in diameter) minimally invasive surgical technique with the insertion of a subcutaneous drain can be utilized on the patient Exclusion Criteria: patients requiring immediate hospitalization patients who have received 2 or more doses of antibiotics in the previous 36 hours patients with diabetes, sickle-cell disease, an immuno-compromising disease, an underlying medical condition predisposing the patient to frequent hospitalizations or medical visits, or indwelling catheters or percutaneous medical devices patients with a concurrent, non-abscess infection patients with an allergy to Trimethoprim-sulfamethoxazole

Ages Eligible for Study
-----------------
Minimum Age: 3 Months
Maximum Age: 17 Years

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 10 days of Trimethoprim-Sulfamethoxazole<br>Oral Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day | Drug: Trimethoprim-Sulfamethoxazole<br>* 3 versus 10 days of drug<br>* Other names: Bactrim;|
| Experimental: 3 days of Trimethoprim-Sulfamethoxazole<br>Oral Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day | Drug: Trimethoprim-Sulfamethoxazole<br>* 3 versus 10 days of drug<br>* Other names: Bactrim;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Failures | Treatment failures were defined as persistent or increased size of the original abscess requiring further medical or surgical intervention. Treatment cure was defined as no or minimal tenderness, erythema, fever, wound drainage, warmth, fluctuance or induration at the 10 to 14 day follow-up. | up to 2 weeks after surgical drainage | 
| Treatment Failures Among Patients Infected With Methicillin-Resistant Staphylococcus Aureus | Treatment failures were defined as persistent or increased size of the original abscess requiring further medical or surgical intervention. Treatment cure was defined as no or minimal tenderness, erythema, fever, wound drainage, warmth, fluctuance or induration at the 10 to 14 day follow-up. | up to 2 weeks after surgical drainage | 
| Treatment Failures Among Patients Infected With Methicillin-Sensitive Staphylococcus Aureus | Treatment failures were defined as persistent or increased size of the original abscess requiring further medical or surgical intervention. Treatment cure was defined as no or minimal tenderness, erythema, fever, wound drainage, warmth, fluctuance or induration at the 10 to 14 day follow-up. | up to 2 weeks after surgical drainage | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrent Skin Infections | Rate of recurrent skin infection among follow-up responders 1 month after enrollment. Patients who were treatment failures were excluded from this analysis since they all received additional medical intervention that could affect the outcome measure. | 1 month after surgical drainage | 
| Recurrent Skin Infections Among Patients Infected With Methicillin-Resistant Staphylococcus Aureus | Rate of recurrent skin infection among follow-up responders 1 month after enrollment. Patients who were treatment failures were excluded from this analysis since they all received additional medical intervention that could affect the outcome measure. | 1 month after surgical drainage | 
| Recurrent Skin Infections Among Patients Infected With Methicillin-Sensitive Staphylococcus Aureus | Rate of recurrent skin infection among follow-up responders 1 month after enrollment. Patients who were treatment failures were excluded from this analysis since they all received additional medical intervention that could affect the outcome measure. | 1 month after surgical drainage | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Methicillin resistent Staphylococcus aureus, Staphylococcus aureus