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| Name | Class |
|---|---|
| U.S. Air Force Office of the Surgeon General | FED |
| Emergency Medicine Foundation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bactrim DS | Active Comparator | Trim/sulfa (800/160) two tablets orally (PO) twice a day (BID) x 7 days |
|
| matched placebo | Placebo Comparator | matched placebo 2 pills orally (PO) twice a day (BID) x 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trim/ Sulfa DS | Drug | bactrim DS (800/160) two tablets PO BID x 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence Rates of Abscesses | Number of patient with a new abscess in same or different location as previous lesion | 30 days after incision and drainage |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gillian R Schmitz | 59th Medical Wing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wilford Hall Medical Center | Lackland Air Force Base | Texas | 78236 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20346539 | Derived | Schmitz GR, Bruner D, Pitotti R, Olderog C, Livengood T, Williams J, Huebner K, Lightfoot J, Ritz B, Bates C, Schmitz M, Mete M, Deye G. Randomized controlled trial of trimethoprim-sulfamethoxazole for uncomplicated skin abscesses in patients at risk for community-associated methicillin-resistant Staphylococcus aureus infection. Ann Emerg Med. 2010 Sep;56(3):283-7. doi: 10.1016/j.annemergmed.2010.03.002. Epub 2010 Mar 26. |
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Patients were assigned by block randomization and data was analyzed with intention to treat analysis.
Patients were enrolled at 3 hospital emergency departments from July 1, 2008 to June 1, 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | Bactrim DS (800/160) Two Tablets PO BID x 7 Days | Active Intervention Arm |
| FG001 | Matched Placebo 2 Pills PO BID x 7 Days | Placebo arm |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| placebo | Drug | matched placebo 2 pills PO BID x 7 days |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bactrim DS (800/160) Two Tablets PO BID x 7 Days | Active Intervention Arm |
| BG001 | Matched Placebo 2 Pills PO BID x 7 Days | Placebo arm |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
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| 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 | Recurrence Rates of Abscesses | Number of patient with a new abscess in same or different location as previous lesion | Posted | Number | participants | 30 days after incision and drainage |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bactrim DS (800/160) Two Tablets PO BID x 7 Days | bactrim DS (800/160) two tablets PO BID x 7 days | 0 | 63 | 15 | 63 | ||
| EG001 | Matched Placebo 2 Pills PO BID x 7 Days | matched placebo 2 pills PO BID x 7 days | 0 | 76 | 27 | 76 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| treatment failure | Skin and subcutaneous tissue disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gillian Schmitz, MD | Wilford Hall Medical Center | 919-724-9185 | gillianmd@gmail.com |
| ID | Term |
|---|---|
| D000038 | Abscess |
| D002481 | Cellulitis |
| ID | Term |
|---|---|
| D013492 | Suppuration |
| D007239 | Infections |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012874 | Skin Diseases, Infectious |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D015662 | Trimethoprim, Sulfamethoxazole Drug Combination |
| ID | Term |
|---|---|
| D013420 | Sulfamethoxazole |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| 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 |
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| >=65 years |
|
| Male |
|