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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

249 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2012-07-31

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Skin Disease, Bacterial Abscess

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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10 days of Trimethoprim-Sulfamethoxazole

Oral Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day

Group Type ACTIVE_COMPARATOR

Trimethoprim-Sulfamethoxazole

Intervention Type DRUG

3 versus 10 days of drug

3 days of Trimethoprim-Sulfamethoxazole

Oral Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day

Group Type EXPERIMENTAL

Trimethoprim-Sulfamethoxazole

Intervention Type DRUG

3 versus 10 days of drug

Interventions

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Trimethoprim-Sulfamethoxazole

3 versus 10 days of drug

Intervention Type DRUG

Other Intervention Names

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Septra Bactrim

Eligibility Criteria

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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

Minimum Eligible Age

3 Months

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes