Antibiotics Versus Placebo in the Treatment of Abscesses in the Emergency Department
Information source: Children's Mercy Hospital Kansas City
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Abscess
Intervention: Trimethoprim-sulfamethoxazole (Drug); Sugar pill (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Children's Mercy Hospital Kansas City Official(s) and/or principal investigator(s):
Joan E Giovanni, MD, Principal Investigator, Affiliation: Children's Mercy Hospital Kansas City
Overall contact:
Joan E Giovanni, MD, Phone: 816-234-3665, Email: gegiovanni@cmh.edu
Summary
The purpose of this study is to determine if there is a difference between an antibiotic,
trimethoprim-sulfamethoxazole versus placebo in healing outcomes of soft tissue abscesses
following incision and drainage.
Clinical Details
Official title: Trimethoprim-sulfamethoxazole Versus Placebo in the Treatment of Cutaneous Abscesses in the Emergency Department
Study design: Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: The objective of this study is to compare clinical indicators of abscess resolution for two different treatment methods: 1) incision and drainage plus placebo (I&D/P) and 2) incision and drainage plus trimethoprim-sulfamethoxazole (TMP-SMX) (I&D/T-S).
Secondary outcome: Comparison of medication adverse effect profiles between the groups, comparison of outcomes between MRSA isolates versus other pathogens between the groups, and analysis of interrater reliability of physical exam findings for a subgroup of patients.
Eligibility
Minimum age: 3 Months.
Maximum age: 17 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Age 3 months to 17 years
- Single, localized soft tissue abscesses requiring incision and drainage with purulent
material obtained
- Diameter of the abscess less than 5cm as measured by the treating physician
Exclusion Criteria:
- Signs of systemic illness or ill-appearing, as determined by the treating physician
- Admission to the hospital following treatment in the Emergency Department
- Known sulfa allergy
- Immunocompromised patients
- Soft tissue abscesses involving the perineum (labia, scrotum, penis, perirectal)
- Previous antibiotic use (for any reason) in the past seven days
- Non-English speaking patients and families
Locations and Contacts
Joan E Giovanni, MD, Phone: 816-234-3665, Email: gegiovanni@cmh.edu
Children's Mercy Hospitals and Clinics, Kansas City, Missouri 64108, United States; Recruiting
Joan E Giovanni, MD, Phone: 816-234-3665, Email: gegiovanni@cmh.edu
Shirlee Rusk, BSN, CCRC, Phone: 816-234-3665
Additional Information
Related publications: Halvorson GD, Halvorson JE, Iserson KV. Abscess incision and drainage in the emergency department--Part I. J Emerg Med. 1985;3(3):227-32. Meislin HW, McGehee MD, Rosen P. Management and microbiology of cutaneous abscesses. JACEP. 1978 May;7(5):186-91. Burney RE. Incision and drainage procedures: soft tissue abscesses in the emergency service. Emerg Med Clin North Am. 1986 Aug;4(3):527-42. Kaplan SL. Treatment of community-associated methicillin-resistant Staphylococcus aureus infections. Pediatr Infect Dis J. 2005 May;24(5):457-8. Review.
Starting date: March 2009
Last updated: June 21, 2011
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