Clinical trial NCT02024867: Evaluation of 3 Versus 10 Days of Antibiotics in Skin Abscesses After Surgical Drainage
Official title: Randomized Non-inferiority Trial of 3 Versus 10 Days of Trimethoprim-Sulfamethoxazole in Community-Associated Skin Abscesses After Surgical Drainage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Disease, Bacterial
Abscess
Keywords: Methicillin resistent Staphylococcus aureus
Staphylococcus aureus
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
Collaborators: name: New York State Department of Health
name: Women & Children's Hospital of Buffalo
First posted: 2013-12-31
Enrollment: 249
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Treatment Failures
timeFrame: up to 2 weeks after surgical drainage
measure: Treatment Failures Among Patients Infected With Methicillin-Resistant Staphylococcus Aureus
timeFrame: up to 2 weeks after surgical drainage
measure: Treatment Failures Among Patients Infected With Methicillin-Sensitive Staphylococcus Aureus
timeFrame: up to 2 weeks after surgical drainage
Secondary outcomes:
measure: Recurrent Skin Infections
timeFrame: 1 month after surgical drainage
measure: Recurrent Skin Infections Among Patients Infected With Methicillin-Resistant Staphylococcus Aureus
timeFrame: 1 month after surgical drainage
measure: Recurrent Skin Infections Among Patients Infected With Methicillin-Sensitive Staphylococcus Aureus
timeFrame: 1 month after surgical drainage
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Women & Children's Hospital of Buffalo
state: New York
Study officials:
affiliation: University at Buffalo
name: Lucy C Holmes, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University at Buffalo
name: Howard Faden, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: Holmes L, Ma C, Qiao H, Drabik C, Hurley C, Jones D, Judkiewicz S, Faden H. Trimethoprim-Sulfamethoxazole Therapy Reduces Failure and Recurrence in Methicillin-Resistant Staphylococcus aureus Skin Abscesses after Surgical Drainage. J Pediatr. 2016 Feb;169:128-34.e1. doi: 10.1016/j.jpeds.2015.10.044. Epub 2015 Nov 11.