NCT02024867 - Evaluation of 3 Versus 10 Days of Antibiotics in Skin Abscesses After Surgical Drainage | Crick

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

249

Conditions

Skin Disease, Bacterial Abscess

Interventions

Trimethoprim-SulfamethoxazoleDRUG

3 versus 10 days of drug

Eligibility

Sex: ALLMin age: 3 MonthsMax age: 17 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Women & Children's Hospital of Buffalo

Buffalo, New York, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: up to 2 weeks after surgical drainage

Secondary Outcomes

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.

Time frame: 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.