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The purpose of the study is to compare rates of cure of abscesses with and without antibiotic treatment after incision and drainage. The purpose of this study is to compare successful rates of cure of abscesses less than 5 cm with antibiotic (oral TMP/SMX) versus non-antibiotic treatment after incision and drainage.
This study is a randomized controlled trial of antibiotic treatment versus placebo after incision and drainage of skin and soft tissue abscesses less than 5 cm in pediatric patients. Eligible patients whose parents/guardians consented them to enrollment were randomized to receive one of two interventions: oral trimethoprim/sulfamethoxazole (TMP/SMX) or placebo after incision and drainage. Every attempt was made to make the placebo capsules and suspensions appear in all aspects like the true drug (was done by the investigational pharmacy department at our institution). Equal numbers of subjects were randomized at the outset to both study groups. Randomization, also done by our investigational pharmacy department, was done in blocks of 20. Patients were followed up in our emergency center at 24 to 48 hours to have any packing removed and to have their clinical/wound status assessed. They were not charged for this visit, and their valet parking was validated. If an individual patient, or an individual patient's wound, was felt to be not improving adequately, that patient was started on formal antibiotic therapy at the treating attending physician's discretion.
Primary outcome:
1. Abscess resolution by parental report 7-10 days after incision and drainage
Secondary outcomes:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| oral trimethoprim/sulfamethoxazole | Active Comparator | subjects with abscesses less than 5cm will be randomized to either study med or placebo |
|
| placebo | Placebo Comparator | Placebo after incision and drainage of abscess less than 5 cm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oral trimethoprim/sulfamethoxazole | Drug | 80 mg caps or 8 mg/ml suspension every 12 hours for 10 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Abscess Resolution | Outcomes will be measured by resolution of size, tenderness, and induration with erythema by parental report 7 - 10 days after initial visit to the Emergency Center | 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Requiring Admission for Failure of Abscess Resolution | Percentage of patients requiring admission to Texas Children's or another hospital within 10 days of incision and drainage | 10 days |
| Number of Participants Requiring New or Modified Antibiotics for Failure of Abscess to Resolve |
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Inclusion Criteria:
1.) Abscess < 5 cm (< 5 cm of induration and fluctuance) requiring incision and drainage 2.) Age > 90 days and < 18 years 3.) Abscess on the trunk, scalp, extremities, or axillae
Exclusion Criteria:
7.) Fever > or = 102.2 degrees Fahrenheit in the previous 24 hours 8.) Systemic symptoms on presentation - i.e., nausea , vomiting, persistent tachycardia, hypotension, diaphoresis, etc.
9.) Signs /symptoms of another infection or illness - i.e., influenza, croup, etc.
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| Name | Affiliation | Role |
|---|---|---|
| Andrea Cruz, MD, MPH | Baylor College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Children's Hospital | Houston | Texas | 77030 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Antibiotic Arm | subjects with abscesses less than 5cm will be randomized to oral trimethoprim/sulfamethoxazole: 80 mg caps or 8 mg/ml suspension every 12 hours for 10 days |
| FG001 | Placebo Arm | Patients with abscesses < 5cm randomized to placebo tablets or suspension twice a day for 10 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Intention to treat
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| ID | Title | Description |
|---|---|---|
| BG000 | Oral Trimethoprim/Sulfamethoxazole | subjects with abscesses less than 5cm will be randomized to study medication, oral trimethoprim/sulfamethoxazole: 80 mg caps or 8 mg/ml suspension every 12 hours for 10 days |
| BG001 | Placebo After Incision and Drainage |
| 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 |
| 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 | Number of Participants With Abscess Resolution | Outcomes will be measured by resolution of size, tenderness, and induration with erythema by parental report 7 - 10 days after initial visit to the Emergency Center | Intention to treat | Posted | Count of Participants | Participants | 10 days |
|
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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 | Antibiotic Arm | subjects with abscesses less than 5cm who received oral trimethoprim/sulfamethoxazole: 80 mg caps or 8 mg/ml suspension every 12 hours for 10 days |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrea T. Cruz, MD, MPH | Baylor College of Medicine | 832-824-5582 | acruz@bcm.edu |
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| ID | Term |
|---|---|
| D000038 | Abscess |
| 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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| Placebo | Drug | Placebo caps or suspension every 12 hours for 10 days |
|
|
For the antibiotic arm, we determined if the child was prescribed a different antibiotic. For the placebo arm, we determined if the child received a prescription for an antibiotic at a subsequent visit (e.g., in the emergency department, by their pediatrician, etc) within 10 days of incision and drainage |
| 10 days |
Patients with abscesses less than 5cm will be randomized to receive placebo. Placebo: Placebo capsules every 12 hours for 10 days |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Number of Participants Requiring Admission for Failure of Abscess Resolution | Percentage of patients requiring admission to Texas Children's or another hospital within 10 days of incision and drainage | Posted | Count of Participants | Participants | 10 days |
|
|
|
| Secondary | Number of Participants Requiring New or Modified Antibiotics for Failure of Abscess to Resolve | For the antibiotic arm, we determined if the child was prescribed a different antibiotic. For the placebo arm, we determined if the child received a prescription for an antibiotic at a subsequent visit (e.g., in the emergency department, by their pediatrician, etc) within 10 days of incision and drainage | Posted | Count of Participants | Participants | 10 days |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Placebo Arm | subjects with abscesses less than 5cm who received placebo capsules or suspension every 12 hours for 10 days | 0 | 11 | 0 | 11 | 0 | 11 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| 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 |