An interventional study of Septra in Abscess, sponsored by 59th Medical Wing. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-06-09.
Sponsored by 59th Medical Wing · Not applicable, Interventional, and Treatment
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.
149 studies on the registry are indexed under Abscess; 32 are open to participants now.
This study's enrollment of 31 is below the median of 96 across 102 interventional studies indexed under Abscess.
Browse Abscess studies →59th Medical Wing is the lead sponsor of 22 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
No antibiotic
Septra DS (800/160) two pills PO BID x 7 days
Drug: Septra
(800/125) PO BID X 7 days
Clinical Improvement at 7 Days After Incision and Drainage
improving wound without evidence of fever, worsening cellulitis or induration
Time frame: 7 days
Recurrence Rates
recurrence of abscess in previous or new location within 30 days
Time frame: 30 days
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.
| Milestone | No Intervention | Septra DS |
|---|---|---|
| Started | 13 | 18 |
| Completed | 13 | 18 |
| Not completed | 0 | 0 |
improving wound without evidence of fever, worsening cellulitis or induration
| participants | No Intervention | Septra DS |
|---|---|---|
| Clinical Improvement at 7 Days After Incision and Drainage | 10 | 14 |
recurrence of abscess in previous or new location within 30 days
| participants | No Intervention | Septra DS |
|---|---|---|
| Recurrence Rates | 1 | 0 |
| Age, Categorical(Participants) | No Intervention | Septra DS | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 13 | 18 | 31 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | No Intervention | Septra DS | Total |
|---|---|---|---|
| Mean | 33.4 ± 2 | 34.5 ± 2 | 34.3 ± 2 |
| Age, Customized(Participants) | No Intervention | Septra DS | Total |
|---|---|---|---|
| Age 18-25 years | 6 | 7 | 13 |
| Age 26-40 years | 2 | 3 | 5 |
| Age 41-65 years | 5 | 8 | 13 |
| Sex: Female, Male(Participants) | No Intervention | Septra DS | Total |
|---|---|---|---|
| Female | 4 | 10 | 14 |
| Male | 9 | 8 | 17 |
| Region of Enrollment(participants) | No Intervention | Septra DS | Total |
|---|---|---|---|
| United States | 13 | 18 | 31 |
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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59th Medical Wing