Abscess, Methicillin-Resistant Staphylococcus Aureus Infection
Conditions
Keywords
Abscess, Cellulitis, Antibiotics, MRSA
Brief summary
Patients will be enrolled in a multi-center study (Wilford Hall Medical Center and Brooke Army Medical Center) to prospectively evaluate outcome after treatment for an uncomplicated skin abscess.
Detailed description
All patients will receive incision and drainage and wound cultures. Patients will then be randomized to 1) septa double strength two pills orally twice a day x 7 days or 2)placebo. Patients will then return to the emergency room on days 3 and 7 for wound repacking and evaluation. The primary outcome recurrence rates within 30 days of treatment. Patients who are not improving at the following visit will then be treated with additional antibiotics if needed. Data will be analyzed both by initial randomization and intention to treat.
Interventions
DRUGTrim/ Sulfa DS
bactrim DS (800/160) two tablets PO BID x 7 days
DRUGplacebo
matched placebo 2 pills PO BID x 7 days
Sponsors
U.S. Air Force Office of the Surgeon General
Emergency Medicine Foundation
59th Medical Wing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* All patients age 18-65 who present to the emergency department with a skin abscess that requires incision and drainage.
Exclusion criteria
* Patients with diabetes, HIV, cancer or other immunocompromised patients. * Additionally, any patients who received antibiotics within one week of presentation or were hospitalized in previous month will be excluded to minimize potential confounding variables. * Pregnant and breastfeeding patients will also be excluded due to possible safety concerns with antibiotic treatment. * Patients with abscesses on head, face, perirectal, or periananal regions, abscesses with known tracks or fistulas to deeper structures, or abscesses requiring surgical drainage in an operating room are excluded. * Finally, patients with sulfa allergy will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence Rates of Abscesses | 30 days after incision and drainage | Number of patient with a new abscess in same or different location as previous lesion |
Countries
United States
Participant flow
Recruitment details
Patients were enrolled at 3 hospital emergency departments from July 1, 2008 to June 1, 2009.
Pre-assignment details
Patients were assigned by block randomization and data was analyzed with intention to treat analysis.
Participants by arm
| Arm | Count |
|---|---|
| Bactrim DS (800/160) Two Tablets PO BID x 7 Days Active Intervention Arm | 63 |
| Matched Placebo 2 Pills PO BID x 7 Days Placebo arm | 76 |
| Total | 139 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 17 | 25 |
Baseline characteristics
| Characteristic | Matched Placebo 2 Pills PO BID x 7 Days | Bactrim DS (800/160) Two Tablets PO BID x 7 Days | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 76 Participants | 63 Participants | 139 Participants |
| Age, Continuous | 30.6 years STANDARD_DEVIATION 13 | 31.6 years STANDARD_DEVIATION 13 | 31.06 years STANDARD_DEVIATION 13 |
| Region of Enrollment United States | 76 participants | 63 participants | 139 participants |
| Sex: Female, Male Female | 35 Participants | 18 Participants | 53 Participants |
| Sex: Female, Male Male | 41 Participants | 45 Participants | 86 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 15 / 63 | 27 / 76 |
| serious Total, serious adverse events | 0 / 63 | 0 / 76 |
Outcome results
Primary
Recurrence Rates of Abscesses
Number of patient with a new abscess in same or different location as previous lesion
Time frame: 30 days after incision and drainage
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bactrim DS (800/160) Two Tablets PO BID x 7 Days | Recurrence Rates of Abscesses | 4 participants |
| Matched Placebo 2 Pills PO BID x 7 Days | Recurrence Rates of Abscesses | 14 participants |