Utility of Trimethoprim-Sulfamethoxazole Use in Skin Abscess Management
Information source: St. Louis University
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Skin Diseases, Infectious
Intervention: Trimethoprim-sulfamethoxazole (Drug); Placebo group (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: St. Louis University Official(s) and/or principal investigator(s):
John Peter, MD, Study Director, Affiliation: St. Louis University
Summary
The purpose of this study is to determine if antibiotica are required in the management of
skin abscess following incision and drainage.
Clinical Details
Official title: A Double Blinded Randomized Controlled Trial for the Management of Pediatric Community Acquired Skin Abscesses - To Treat or Not to Treat With Antibiotics
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment
Primary outcome: skin abscess resolution
Secondary outcome: new lesion development and spread of skin abscesses/infection to other family members
Detailed description:
This is a double-blind, randomized controlled trial at an urban pediatric emergency
department. Sample size (162) was based on a threshold equivalence of 7% (α = 0. 05, power =
80%). Inclusion criteria were: non-toxic, immunocompetent, 3 months to 18 years old,
English-speaking patients with clinical or ultrasound identified skin abscesses who were not
on antibiotics. Patients were block randomized to receive placebo or
trimethoprim/sulfamethoxazole following incision and drainage. Follow-up was a call at 2-3
days & a repeat visit or call at 10-14 days. Treatment failure was defined as: persistent
erythema, tenderness, and/or draining lesions. New lesion was defined as: primary resolution
with development of new lesion (furuncle, carbuncle or abscess) at a different location.
Compliance was evaluated by the return of the study medication or by patient report.
Eligibility
Minimum age: 3 Months.
Maximum age: 18 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- non-toxic patients
- immunocompetent patients
- 3 months to 18 years old
- English-speaking patients
- skin abscesses
- not on antibiotics
Exclusion Criteria:
- toxic patients
- immunocompromising co-morbidities
- less than 3 months old or older than 18 years of age
- non-english speaking
- on antibiotics
Locations and Contacts
Cardinal Glennon Children's Medical Center, St Louis, Missouri 63104, United States
Additional Information
Related publications: Pallin DJ, Egan DJ, Pelletier AJ, Espinola JA, Hooper DC, Camargo CA Jr. Increased US emergency department visits for skin and soft tissue infections, and changes in antibiotic choices, during the emergence of community-associated methicillin-resistant Staphylococcus aureus. Ann Emerg Med. 2008 Mar;51(3):291-8. Epub 2008 Jan 28. Korownyk C, Allan GM. Evidence-based approach to abscess management. Can Fam Physician. 2007 Oct;53(10):1680-4. Review. Cohen PR. Community-acquired methicillin-resistant Staphylococcus aureus skin infections: implications for patients and practitioners. Am J Clin Dermatol. 2007;8(5):259-70. Review. Lee MC, Rios AM, Aten MF, Mejias A, Cavuoti D, McCracken GH Jr, Hardy RD. Management and outcome of children with skin and soft tissue abscesses caused by community-acquired methicillin-resistant Staphylococcus aureus. Pediatr Infect Dis J. 2004 Feb;23(2):123-7.
Starting date: July 2006
Ending date: May 2008
Last updated: May 14, 2008
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