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Randomized Controlled Trial of Antibiotics in the Management of Children With Community-Acquired Skin and Soft Tissue Abscess Undergoing Incision and Drainage

Information source: Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Skin and Soft Tissue Abscess; Methicillin-resistant Staphylococcus Aureus (MRSA) Infection

Intervention: Oral Clindamycin (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Ann & Robert H Lurie Children's Hospital of Chicago

Official(s) and/or principal investigator(s):
Katherine A Barsness, MD, Principal Investigator, Affiliation: Ann & Robert H Lurie Children's Hospital of Chicago

Overall contact:
Andrea Chen, MS, Phone: 773-880-8139, Email: ajchen@childrensmemorial.org

Summary

The purpose of this study is to better understand why children develop methicillin-resistant Staphylococcus aureus (MRSA) skin infections that require surgical drainage and whether antibiotics are helpful after the infection is drained in the operating room.

Clinical Details

Official title: Randomized Controlled Trial of Antibiotics in the Management of Children With Community-Acquired Skin and Soft Tissue Abscess Undergoing Incision and Drainage

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: The primary objective is to measure clinical resolution of skin abscess at routine follow-up visit 10-14 days post operation.

Secondary outcome: Secondary outcomes measured include incidence of additional skin and soft tissue infections in patient and in household contacts as determined by healthcare provider. Compliance to antibiotic regime will also be assessed at this time.

Detailed description: The emergence of community acquired methicillin-resistant Staphylococcus aureus (MRSA) as a pervasive cause of skin and soft tissue infections has increased the number of children requiring incision and drainage (I&D) procedures and heightened concerns about the optimal treatment strategy. Data on patients with methicillin-sensitive Staphylococcus aureus (MSSA) abscesses, as well as emerging data on children with minor MRSA skin and soft tissue abscesses suggest that I&D alone is sufficient therapy. However, given concerns about the pathogenicity of MRSA infections, many patients who require hospital admission and I&D in the operating room receive postoperative antibiotics. The primary objective of this randomized controlled trial is to compare the effect of 5 days versus 1 day of postoperative antibiotics on the rate of treatment failure following I&D of abscesses in children in the era of pervasive MRSA infection. Secondary outcomes to be measured include incidence of additional skin and soft tissue infections in other body sites and incidence of these infections in family members and household contacts. Prospective data will be collected from wound cultures, as well as from nasal, rectal and skin cultures sent at the time of initial I&D to assess for MRSA carrier status. Finally, survey data will be used to assess epidemiologic risk factors.

Eligibility

Minimum age: 1 Month. Maximum age: 17 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Children between 1 month and 17 years of age who undergo Incision and Drainage of a

skin and soft tissue abscess by a member of the Children's Memorial Hospital pediatric surgery faculty. Exclusion Criteria:

- Children who developed their infection while hospitalized or within 2 weeks of

unrelated hospital discharge will be excluded.

- Children with surgical site infections will be excluded.

- Children with inherent or acquired immunodeficiency, including but not limited to

transplant patients and patients on chemotherapy or systemic corticosteroids will be excluded.

- Patients admitted to the Infectious Disease service may be excluded at the discretion

of the ID attending.

- Patients who are found to have no discreet fluid collections at the time of attempted

incision and drainage will be excluded.

- Patients allergic or intolerant to both bactrim and clindamycin will be excluded.

- Patients with cellulitis greater than 5 cm beyond the lateral margin of the abscess

(as determined by intraoperative measurements) will be excluded.

Locations and Contacts

Andrea Chen, MS, Phone: 773-880-8139, Email: ajchen@childrensmemorial.org

Children's Memorial Hospital, Chicago, Illinois 60622, United States; Recruiting
Additional Information

Starting date: February 2010
Last updated: December 21, 2011

Page last updated: August 23, 2015

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