Abscess
Conditions
Keywords
abscess, outcomes, antibiotics, incision and drainage, skin abscess
Brief summary
The purpose of this study is to determine if there is a difference between an antibiotic, trimethoprim-sulfamethoxazole versus placebo in healing outcomes of soft tissue abscesses following incision and drainage.
Interventions
DRUGTrimethoprim-sulfamethoxazole
10mg/kg/day (based on trimethoprim component), divided twice daily for ten days (maximum dose: 160mg (TMP component) per dose)
DRUGSugar pill
10mg/kg/day divided twice daily for ten days. Placebo liquid will contain simple syrup, lactose powder, grape flavor, and food coloring. Placebo capsules will contain lactose powder.
Sponsors
Blue Cross Blue Shield
Children's Mercy Hospital Kansas City
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Months to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 3 months to 17 years * Single, localized soft tissue abscesses requiring incision and drainage with purulent material obtained * Diameter of the abscess less than 5cm as measured by the treating physician
Exclusion criteria
* Signs of systemic illness or ill-appearing, as determined by the treating physician * Admission to the hospital following treatment in the Emergency Department * Known sulfa allergy * Immunocompromised patients * Soft tissue abscesses involving the perineum (labia, scrotum, penis, perirectal) * Previous antibiotic use (for any reason) in the past seven days * Non-English speaking patients and families
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Health Outcomes After Use With Trimethoprim-sulfamethaxazole | two years |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Trimethoprim-sulfamethaxazole Incision and drainage of the abscess and treatment with oral TMP-SMX (100 patients)
Trimethoprim-sulfamethoxazole: 10mg/kg/day (based on trimethoprim component), divided twice daily for ten days (maximum dose: 160mg (TMP component) per dose) | 70 |
| Sugar Pill Incision and drainage of the abscess and treatment with oral placebo (100 patients)
Sugar pill: 10mg/kg/day divided twice daily for ten days. Placebo liquid will contain simple syrup, lactose powder, grape flavor, and food coloring. Placebo capsules will contain lactose powder. | 70 |
| Total | 140 |
Baseline characteristics
| Characteristic | Trimethoprim-sulfamethaxazole | Sugar Pill | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 70 Participants | 70 Participants | 140 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 | 70 participants | 70 participants | 140 participants |
| Sex: Female, Male Female | 38 Participants | 40 Participants | 78 Participants |
| Sex: Female, Male Male | 32 Participants | 30 Participants | 62 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 70 | 0 / 70 |
| serious Total, serious adverse events | 0 / 70 | 0 / 70 |
Outcome results
Primary
Health Outcomes After Use With Trimethoprim-sulfamethaxazole
Time frame: two years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Trimethoprim-sulfamethaxazole | Health Outcomes After Use With Trimethoprim-sulfamethaxazole | 0 Percentage of outcomes assessed |
| Sugar Pill | Health Outcomes After Use With Trimethoprim-sulfamethaxazole | 0 Percentage of outcomes assessed |