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Completed

NCT Number: NCT02024867

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

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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Key information

Conditions

Skin Disease, Bacterial Abscess Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Diseases, Bacterial Skin Diseases, Infectious Skin and Connective Tissue Diseases Staphylococcal Infections Suppuration

Age range

3 month–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Women & Children's Hospital of Buffalo

Buffalo, New York, 14222, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trimethoprim-sulfamethoxazole

Drug

3 versus 10 days of drug

Other names: Septra, Bactrim

Primary outcomes

  1. Treatment Failures

    Time frame: up to 2 weeks after surgical drainage

    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.

  2. Treatment Failures Among Patients Infected With Methicillin-Resistant Staphylococcus Aureus

    Time frame: up to 2 weeks after surgical drainage

    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.

  3. Treatment Failures Among Patients Infected With Methicillin-Sensitive Staphylococcus Aureus

    Time frame: up to 2 weeks after surgical drainage

    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.

Secondary outcomes

  1. Recurrent Skin Infections

    Time frame: 1 month after surgical drainage

    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.

  2. Recurrent Skin Infections Among Patients Infected With Methicillin-Resistant Staphylococcus Aureus

    Time frame: 1 month after surgical drainage

    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.

  3. Recurrent Skin Infections Among Patients Infected With Methicillin-Sensitive Staphylococcus Aureus

    Time frame: 1 month after surgical drainage

    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.

Sponsors and collaborators

Lead sponsor

Lucy Holmes, MD

Other

Collaborators

  • New York State Department of Health
  • Women & Children's Hospital of Buffalo

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Dec 31, 2013
Registry last updated
Oct 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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