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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No intervention | No Intervention | No antibiotic | |
| Septra DS | Active Comparator | Septra DS (800/160) two pills PO BID x 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Septra | Drug | (800/125) PO BID X 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Improvement at 7 Days After Incision and Drainage | improving wound without evidence of fever, worsening cellulitis or induration | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence Rates | recurrence of abscess in previous or new location within 30 days | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wilford Hall Medical Center | Lackland Air Force Base | Texas | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | No Intervention | No antibiotic |
| FG001 | Septra DS | Septra DS (800/160) two pills PO BID x 7 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | No Intervention | No antibiotic |
| BG001 | Septra DS | Septra DS (800/160) two pills PO BID x 7 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Age (Years) |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Clinical Improvement at 7 Days After Incision and Drainage | improving wound without evidence of fever, worsening cellulitis or induration | Posted | Number | participants | 7 days |
|
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gillian Schmitz, MD | Wilford Hall Medical Center | 919-724-9185 | gillianmd@gmail.com |
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| ID | Term |
|---|---|
| D000038 | Abscess |
| D002481 | Cellulitis |
| ID | Term |
|---|---|
| D013492 | Suppuration |
| D007239 | Infections |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D015662 | Trimethoprim, Sulfamethoxazole Drug Combination |
| ID | Term |
|---|---|
| D013420 | Sulfamethoxazole |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
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| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Recurrence Rates | recurrence of abscess in previous or new location within 30 days | Posted | Number | participants | 30 days |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D012874 | Skin Diseases, Infectious |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009930 |
| Organic Chemicals |
| D013424 | Sulfanilamides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D014295 | Trimethoprim |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |