Abscess
Conditions
Keywords
abscess, cellulitis, antibiotics, MRSA
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)no antibiotic or 2) bacterium double strength (DS) (800/160) two tablets per oral (PO) twice a day x 7 days. This is the dose recommended for treating skin and soft tissue infections. (Ellis et al. Current Opinion in Infectious Diseases. 18(6):496-501, December 2005) Patients will then return to the emergency room (ER) on days 3 and 7 for wound repacking and evaluation. The primary outcome is clinical cure of abscess at 7 days after incision and drainage and recurrence rates within 30 days of treatment. Patients who are not improving at the following visit will then be treated with additional antibiotics or admission if needed. Data will be analyzed both by initial randomization and intention to treat. This serves as the pilot for the full placebo controlled randomized trial.
Interventions
DRUGSeptra
(800/125) PO BID X 7 days
Sponsors
59th Medical Wing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* all patients age 18-55 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 * 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 * basic Military Trainees will also be excluded from participation * 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 * patients with sulfa allergy will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Improvement at 7 Days After Incision and Drainage | 7 days | improving wound without evidence of fever, worsening cellulitis or induration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence Rates | 30 days | recurrence of abscess in previous or new location within 30 days |
Countries
United States
Participant flow
Recruitment details
Patients were recruited who presented to the ER with an uncomplicated skin abscess who met inclusion criteria and did not meet exclusion criteria. Informed consent was obtained.
Participants by arm
| Arm | Count |
|---|---|
| No Intervention No antibiotic | 13 |
| Septra DS Septra DS (800/160) two pills PO BID x 7 days | 18 |
| Total | 31 |
Baseline characteristics
| Characteristic | No Intervention | Septra DS | 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 | 13 Participants | 18 Participants | 31 Participants |
| Age, Continuous | 33.4 years STANDARD_DEVIATION 2 | 34.5 years STANDARD_DEVIATION 2 | 34.3 years STANDARD_DEVIATION 2 |
| Age, Customized Age 18-25 years | 6 Participants | 7 Participants | 13 Participants |
| Age, Customized Age 26-40 years | 2 Participants | 3 Participants | 5 Participants |
| Age, Customized Age 41-65 years | 5 Participants | 8 Participants | 13 Participants |
| Region of Enrollment United States | 13 participants | 18 participants | 31 participants |
| Sex: Female, Male Female | 4 Participants | 10 Participants | 14 Participants |
| Sex: Female, Male Male | 9 Participants | 8 Participants | 17 Participants |
Outcome results
Primary
Clinical Improvement at 7 Days After Incision and Drainage
improving wound without evidence of fever, worsening cellulitis or induration
Time frame: 7 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| No Intervention | Clinical Improvement at 7 Days After Incision and Drainage | 10 participants |
| Septra DS | Clinical Improvement at 7 Days After Incision and Drainage | 14 participants |
Secondary
Recurrence Rates
recurrence of abscess in previous or new location within 30 days
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| No Intervention | Recurrence Rates | 1 participants |
| Septra DS | Recurrence Rates | 0 participants |