Abscess
Conditions
Keywords
abscess, Abscesses in the pediatric emergency population
Brief summary
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.
Detailed description
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: 1. Admission to the hospital because of worsening infection 2. Receipt of antibiotics (placebo arm) or change in antibiotics (antibiotic arm)
Interventions
DRUGoral trimethoprim/sulfamethoxazole
80 mg caps or 8 mg/ml suspension every 12 hours for 10 days
DRUGPlacebo
Placebo caps or suspension every 12 hours for 10 days
Sponsors
Baylor College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
90 Days to 18 Years
Healthy volunteers
No
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
1. Multiple abscesses 2. Abscess located on the hands, face, or perineum 3. Abscess as a result of a bite wound 4. Immunocompromised patient - i.e., diabetes, sickle cell, chronic steroid therapy (\> 10 days), etc. 5. Previously failed 48 hours or greater therapy on any antibiotic regimen 6.) Drug allergy to TMP/SMX 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Abscess Resolution | 10 days | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Requiring Admission for Failure of Abscess Resolution | 10 days | Percentage of patients requiring admission to Texas Children's or another hospital within 10 days of incision and drainage |
| Number of Participants Requiring New or Modified Antibiotics for Failure of Abscess to Resolve | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 12 |
| Placebo After Incision and Drainage Patients with abscesses less than 5cm will be randomized to receive placebo.
Placebo: Placebo capsules every 12 hours for 10 days | 11 |
| Total | 23 |
Baseline characteristics
| Characteristic | Oral Trimethoprim/Sulfamethoxazole | Placebo After Incision and Drainage | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 12 Participants | 11 Participants | 23 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 12 participants | 11 participants | 23 participants |
| Sex: Female, Male Female | 5 Participants | 5 Participants | 10 Participants |
| Sex: Female, Male Male | 7 Participants | 6 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 11 |
| other Total, other adverse events | 0 / 12 | 0 / 11 |
| serious Total, serious adverse events | 0 / 12 | 0 / 11 |
Outcome results
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
Time frame: 10 days
Population: Intention to treat
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Antibiotic Arm | Number of Participants With Abscess Resolution | 11 Participants |
| Placebo Arm | Number of Participants With Abscess Resolution | 9 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
Time frame: 10 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Antibiotic Arm | Number of Participants Requiring Admission for Failure of Abscess Resolution | 0 Participants |
| Placebo Arm | Number of Participants Requiring Admission for Failure of Abscess Resolution | 0 Participants |
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
Time frame: 10 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Antibiotic Arm | Number of Participants Requiring New or Modified Antibiotics for Failure of Abscess to Resolve | 1 Participants |
| Placebo Arm | Number of Participants Requiring New or Modified Antibiotics for Failure of Abscess to Resolve | 2 Participants |