Abscesses
Conditions
Keywords
abcess, MRSA, cellulitis, antibiotics, uncomplicated abscesses
Brief summary
Patients will be enrolled in a multi-center study to prospectively evaluate outcome after treatment for an uncomplicated skin abscess. All patients will receive incision and drainage and wound cultures. Patients will then be randomized to 1) placebo two tablets PO BID X 7 days or 2) bactrim DS (800/160) two tablets PO BID x 7 days. Patients will then return to the emergency department ED) at 48 hours and 7 for wound repacking and evaluation. The primary outcome is treatment failure rates at 7 days after incision and drainage. Patients who are clinically worsening or not improving after 48 hours will then be treated with additional antibiotics or admission if needed. Data will be analyzed both by initial randomization and intention to treat.
Interventions
DRUGbactrim
bactrim DS (800/160) 2 pills PO BID x 7 days
DRUGplacebo
placebo 2 pills po BID x 7 days
Sponsors
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
16 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Inclusion criteria include all patients age 16 and older who present to the emergency department with a skin abscess that requires incision and drainage.
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Failures at 7 Days | 7 days | worsening abscess or new recurrence of abscess |
Countries
United States
Participant flow
Recruitment details
July 1, 2008 - June 1, 2009 in emergency department
Participants by arm
| Arm | Count |
|---|---|
| Active Comparator Bactrim DS (800/160) 2 pills po BID x 7 days | 96 |
| Placebo Matched placebo 2 pills po BID x 7 days | 116 |
| Total | 212 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 8 | 14 |
Baseline characteristics
| Characteristic | Placebo | Active Comparator | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 116 Participants | 94 Participants | 210 Participants |
| Age Continuous | 31.1 years STANDARD_DEVIATION 12.5 | 31.5 years STANDARD_DEVIATION 13.3 | 31.3 years STANDARD_DEVIATION 12.8 |
| Region of Enrollment United States | 116 participants | 96 participants | 212 participants |
| Sex: Female, Male Female | 44 Participants | 28 Participants | 72 Participants |
| Sex: Female, Male Male | 72 Participants | 68 Participants | 140 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 212 | 0 / 212 |
Outcome results
Primary
Treatment Failures at 7 Days
worsening abscess or new recurrence of abscess
Time frame: 7 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Active Comparator | Treatment Failures at 7 Days | 15 participants |
| Placebo | Treatment Failures at 7 Days | 27 participants |