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Recruitment of this population in the hospital setting not practical.
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Background: Skin abscesses are a growing problem in the general pediatric population around the world. While the standard treatment for an abscess/boil is incision and drainage, many physicians also prescribe antibiotics, despite the lack of evidence that antibiotics are necessary to help the wound heal. The purpose of this research study is to determine whether antibiotics are necessary after incision and drainage of a skin abscess in children. This is an important question because medical evidence has shown that using antibiotics when they are not needed has contributed to the increase of bacterial antibiotic resistance. In fact, several of the antibiotics that successfully killed Staph bacteria several years ago are now no longer effective because of antibiotic resistance. Now resistant forms of Staph bacteria, called "Community-Acquired Methicillin-Resistant Staph Aureus" (CA-MRSA), account for 50-85% of all pediatric skin abscesses. If antibiotics are not necessary then withholding them when appropriate may help slow the progression of antibiotic-resistant Staph infections.
Objective(s) and Hypothesis(es): The investigators believe that antibiotics are no better than placebo at achieving a cure after drainage of an abscess in a child. The objective of this study is to answer the question: Do antibiotics after abscess drainage result in a better chance of cure than placebo?
Potential Impact: If abscess drainage alone is shown to be as effective as drainage followed by antibiotics, then the routine use of antibiotics for this problem could be avoided. This would help limit the increasing antibiotic resistance of bacteria (especially CA-MRSA) in communities around the world. A well-designed study may provide the evidence to change the way children are treated for abscesses in a future where antibiotic resistant bacteria will be even more of a public health challenge.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drainage and placebo | Experimental | Incision and drainage with placebo. |
|
| Drainage with TMP/SX | Active Comparator | Drainage with Bactrim |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Incision and drainage | Procedure |
| ||
| Trimethoprim/Sulfamethoxazole (Bactrim) |
| Measure | Description | Time Frame |
|---|---|---|
| Resolution of abscess | 5-7 days |
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Inclusion Criteria:
Any child (age 6 months-18 years old) that:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Pranikoff, M.D. | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University School of Medicine | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Term |
|---|---|
| D000038 | Abscess |
| D000072836 | Surgical Wound |
| ID | Term |
|---|---|
| D013492 | Suppuration |
| D007239 | Infections |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D004322 | Drainage |
| D014295 | Trimethoprim |
| D013420 | Sulfamethoxazole |
| D015662 | Trimethoprim, Sulfamethoxazole Drug Combination |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Drug |
Trimethoprim/Sulfamethoxazole, oral |
|
| Placebo | Drug |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |
| D006571 |
| Heterocyclic Compounds |
| 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 |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |