Clinical trial NCT00679302: Utility of Trimethoprim-sulfamethoxazole Use in Skin Abscess Management
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Skin Diseases, Infectious
Keywords: skin abscess
CA-MRSA
Lead sponsor: St. Louis University
Sponsor class: OTHER
First posted: 2008-05-16
Enrollment: 161
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if antibiotics are required in the management of skin abscess following incision and drainage.

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 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

Primary outcomes:
measure: Skin Abscess Resolution
timeFrame: 10-14 days
Secondary outcomes:
measure: New Lesion Development and Spread of Skin Abscesses (on Subject)
timeFrame: 10-14 days and 3 month
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Cardinal Glennon Children's Medical Center
state: Missouri
Study officials:
affiliation: St. Louis University
name: John Peter, MD
role: STUDY_DIRECTOR
References:
citation: 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. doi: 10.1016/j.annemergmed.2007.12.004. Epub 2008 Jan 28.
citation: Korownyk C, Allan GM. Evidence-based approach to abscess management. Can Fam Physician. 2007 Oct;53(10):1680-4.
citation: Cohen PR. Community-acquired methicillin-resistant Staphylococcus aureus skin infections: implications for patients and practitioners. Am J Clin Dermatol. 2007;8(5):259-70. doi: 10.2165/00128071-200708050-00001.
citation: 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. doi: 10.1097/01.inf.0000109288.06912.21.
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.