Randomized Controlled Trial of Antibiotics in the Management of Children With Community-Acquired Skin and Soft Tissue Abscess Undergoing Incision and Drainage
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Skin and Soft Tissue Abscess Methicillin-resistant Staphylococcus Aureus (MRSA) Infection |
Drug: Oral Clindamycin |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomized Controlled Trial of Antibiotics in the Management of Children With Community-Acquired Skin and Soft Tissue Abscess Undergoing Incision and Drainage |
- The primary objective is to measure clinical resolution of skin abscess at routine follow-up visit 10-14 days post operation. [ Time Frame: At office visit 10-14 days post operation ] [ Designated as safety issue: No ]
- 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. [ Time Frame: Three timepoints: 10-14 days post operation, 3 months post op, and 9 months post op ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 250 |
| Study Start Date: | February 2010 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 5 days postoperative antibiotic
Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).
|
Drug: Oral Clindamycin
Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).
|
|
Experimental: 1 day postoperative antibiotic
Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).
|
Drug: Oral Clindamycin
Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).
|
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| Ages Eligible for Study: | 1 Month to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Contact: Andrea Chen, MS | 773-880-8139 | ajchen@childrensmemorial.org |
| United States, Illinois | |
| Children's Memorial Hospital | Recruiting |
| Chicago, Illinois, United States, 60622 | |
| Principal Investigator: | Katherine A Barsness, MD | Ann & Robert H Lurie Children's Hospital of Chicago |
More Information
No publications provided
| Responsible Party: | Ann & Robert H Lurie Children's Hospital of Chicago |
| ClinicalTrials.gov Identifier: | NCT01498744 History of Changes |
| Other Study ID Numbers: | IRB # 2010-14118 |
| Study First Received: | December 20, 2011 |
| Last Updated: | December 21, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Ann & Robert H Lurie Children's Hospital of Chicago:
|
Skin and Soft Tissue Abscess Methicillin-resistant Staphylococcus aureus (MRSA) Incision and Drainage |
Clindamycin Trimethoprim-sulfamethoxazole Skin Infection |
Additional relevant MeSH terms:
|
Abscess Staphylococcal Infections Suppuration Infection Inflammation Pathologic Processes Gram-Positive Bacterial Infections Bacterial Infections Anti-Bacterial Agents Clindamycin Clindamycin-2-phosphate Sulfamethoxazole Trimethoprim |
Trimethoprim-Sulfamethoxazole Combination Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Infective Agents, Urinary Renal Agents Antimalarials Antiprotozoal Agents Antiparasitic Agents Folic Acid Antagonists |
ClinicalTrials.gov processed this record on May 23, 2013