Abscess Soft Tissue, Methicillin-resistant Staphylococcus Aureus (MRSA) Infection, Skin Abscess
Conditions
Keywords
Skin and Soft Tissue Abscess, Methicillin-resistant Staphylococcus aureus (MRSA), Incision and Drainage, Clindamycin, Trimethoprim-sulfamethoxazole, Skin Infection
Brief 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.
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.
Interventions
DRUGOral 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).
Sponsors
Ann & Robert H Lurie Children's Hospital of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Months to 17 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Resolution of Skin Abscess at Routine Follow-up Visit 10-14 Days Post Operation. | At office visit 10-14 days post operation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Additional Skin and Soft Tissue Infections in Patient | Three timepoints: 10-14 days post operation, 3 months post op, and 9 months post op | The outcome measure was reported by responding to a yes/no |
| Additional Skin or Soft Tissue Infections in Household Contacts | Three timepoints: 10-14 days post operation, 3 months post op, and 9 months post op | — |
| Complication to Antibiotic Regime | Three timepoints: 10-14 days post operation, 3 months post op, and 9 months post op | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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).
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). | 22 |
| 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).
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). | 31 |
| Total | 53 |
Baseline characteristics
| Characteristic | 5 Days Postoperative Antibiotic | 1 Day Postoperative Antibiotic | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 22 Participants | 31 Participants | 53 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 22 participants | 31 participants | 53 participants |
| Sex: Female, Male Female | NA Participants | NA Participants | NA Participants |
| Sex: Female, Male Male | NA Participants | NA Participants | NA Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 22 | 0 / 31 |
| serious Total, serious adverse events | 0 / 22 | 0 / 31 |
Outcome results
Primary
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
Population: Only participants that had data collected for this outcome measure are included above.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 5 Days Postoperative Antibiotic | Clinical Resolution of Skin Abscess at Routine Follow-up Visit 10-14 Days Post Operation. | 0 participants |
| 1 Day Postoperative Antibiotic | Clinical Resolution of Skin Abscess at Routine Follow-up Visit 10-14 Days Post Operation. | 1 participants |
Secondary
Additional Skin and Soft Tissue Infections in Patient
The outcome measure was reported by responding to a yes/no
Time frame: Three timepoints: 10-14 days post operation, 3 months post op, and 9 months post op
Population: Only participants that had data collected for this outcome measure are included here.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 5 Days Postoperative Antibiotic | Additional Skin and Soft Tissue Infections in Patient | 10-14 Days(n=14,19) | 0 participants |
| 5 Days Postoperative Antibiotic | Additional Skin and Soft Tissue Infections in Patient | 90 Day(n=13,15) | 2 participants |
| 5 Days Postoperative Antibiotic | Additional Skin and Soft Tissue Infections in Patient | 9 Month(n=10,9) | 2 participants |
| 1 Day Postoperative Antibiotic | Additional Skin and Soft Tissue Infections in Patient | 10-14 Days(n=14,19) | 2 participants |
| 1 Day Postoperative Antibiotic | Additional Skin and Soft Tissue Infections in Patient | 90 Day(n=13,15) | 4 participants |
| 1 Day Postoperative Antibiotic | Additional Skin and Soft Tissue Infections in Patient | 9 Month(n=10,9) | 3 participants |
Secondary
Additional Skin or Soft Tissue Infections in Household Contacts
Time frame: Three timepoints: 10-14 days post operation, 3 months post op, and 9 months post op
Population: Only participants that had data collected for this outcome measure are included above.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 5 Days Postoperative Antibiotic | Additional Skin or Soft Tissue Infections in Household Contacts | 10-14 Days(n=13,19) | 0 participants |
| 5 Days Postoperative Antibiotic | Additional Skin or Soft Tissue Infections in Household Contacts | 90 Day(n=13,13) | 2 participants |
| 5 Days Postoperative Antibiotic | Additional Skin or Soft Tissue Infections in Household Contacts | 9 Month(n=9,10) | 2 participants |
| 1 Day Postoperative Antibiotic | Additional Skin or Soft Tissue Infections in Household Contacts | 90 Day(n=13,13) | 4 participants |
| 1 Day Postoperative Antibiotic | Additional Skin or Soft Tissue Infections in Household Contacts | 9 Month(n=9,10) | 2 participants |
| 1 Day Postoperative Antibiotic | Additional Skin or Soft Tissue Infections in Household Contacts | 10-14 Days(n=13,19) | 2 participants |
Secondary
Complication to Antibiotic Regime
Time frame: Three timepoints: 10-14 days post operation, 3 months post op, and 9 months post op
Population: Only participants that had data collected for this outcome measure are included above.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 5 Days Postoperative Antibiotic | Complication to Antibiotic Regime | 10-14 Days(n=14,19) | 0 participants |
| 5 Days Postoperative Antibiotic | Complication to Antibiotic Regime | 90 Day(n=0,0) | 0 participants |
| 5 Days Postoperative Antibiotic | Complication to Antibiotic Regime | 9 Month(n=0,0) | 0 participants |
| 1 Day Postoperative Antibiotic | Complication to Antibiotic Regime | 10-14 Days(n=14,19) | 2 participants |
| 1 Day Postoperative Antibiotic | Complication to Antibiotic Regime | 90 Day(n=0,0) | 0 participants |
| 1 Day Postoperative Antibiotic | Complication to Antibiotic Regime | 9 Month(n=0,0) | 0 participants |