The purpose of this study is to determine if antibiotica are required in the management of skin abscess following incision and drainage...
Date First Received: May 14, 2008
Last Updated: May 14, 2008
Verified by: St. Louis University, May 2008
Clinical Trial Phase: Phase 4 | Start Date: July 2006
Overall Status: Completed
Estimated Enrollment: 161
Brief Summary
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”
Condition Keyword(s):
Intervention(s):
The purpose of this study is to determine if antibiotica are required in the management of skin abscess following incision and drainage.
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment
Study Primary Completion Date: February 2008
Detailed Clinical Trial 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.
Intervention(s) in this Clinical Trial
- Drug: Trimethoprim-sulfamethoxazole
- Trimethoprim-sulfamethoxazole suspension 10-12mg/kg/day divided twice daily for 10 days
- Drug: Placebo group
- simethicone and bitter mixture
Arms, Groups and Cohorts in this Clinical Trial
- Placebo Comparator: placebo group
- Maalox and bitter mixture
- Active Comparator: antibiotic group
- Trimethoprim-sulfamethoxazole suspension
Outcome Measures for this Clinical Trial
Primary Measures
- skin abscess resolution
- Time Frame: 10-14 days
Safety Issue?: Yes
- Time Frame: 10-14 days
Secondary Measures
- new lesion development and spread of skin abscesses/infection to other family members
- Time Frame: 10-14 days and 3 month
Safety Issue?: No
- Time Frame: 10-14 days and 3 month
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 3 Months
Maximum Age for this Clinical Trial: 18 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: St. Louis University
Overall Clinical Trial Officials and Contacts
John Peter, MD Study Director St. Louis University
Related Publications
References
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.
Additional Information
Information obtained from ClinicalTrials.gov on September 05, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00679302
Study ID Number: 14415
ClinicalTrials.gov Identifier: NCT00679302
Health Authority: United States: Institutional Review Board
Clinical Trials Authorship and Review
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