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

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.

Full Title of Study: “Randomized Non-inferiority Trial of 3 Versus 10 Days of Trimethoprim-Sulfamethoxazole in Community-Associated Skin Abscesses After Surgical Drainage”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2012

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).

Interventions

  • Drug: Trimethoprim-Sulfamethoxazole
    • 3 versus 10 days of drug

Arms, Groups and Cohorts

  • Active Comparator: 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
  • Experimental: 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

Clinical Trial Outcome Measures

Primary Measures

  • 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.
  • 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.
  • 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 Measures

  • 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.
  • 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.
  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 3 Months

Maximum Age: 17 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Lucy Holmes, MD
  • Collaborator
    • New York State Department of Health
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Lucy Holmes, MD, Clinical Associate Professor of Pediatrics – State University of New York at Buffalo
  • Overall Official(s)
    • Lucy C Holmes, MD, Principal Investigator, University at Buffalo
    • Howard Faden, MD, Study Chair, University at Buffalo

References

Duong M, Markwell S, Peter J, Barenkamp S. Randomized, controlled trial of antibiotics in the management of community-acquired skin abscesses in the pediatric patient. Ann Emerg Med. 2010 May;55(5):401-7. doi: 10.1016/j.annemergmed.2009.03.014. Epub 2009 May 5.

Schmitz GR, Bruner D, Pitotti R, Olderog C, Livengood T, Williams J, Huebner K, Lightfoot J, Ritz B, Bates C, Schmitz M, Mete M, Deye G. Randomized controlled trial of trimethoprim-sulfamethoxazole for uncomplicated skin abscesses in patients at risk for community-associated methicillin-resistant Staphylococcus aureus infection. Ann Emerg Med. 2010 Sep;56(3):283-7. doi: 10.1016/j.annemergmed.2010.03.002. Epub 2010 Mar 26. Erratum in: Ann Emerg Med. 2010 Nov;56(5):588.

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