Skin Diseases, Infectious
Conditions
Keywords
skin abscess, CA-MRSA
Brief summary
The purpose of this study is to determine if antibiotics are required in the management of skin abscess following incision and drainage.
Detailed description
This is a double-blind, randomized controlled trial at an urban pediatric emergency department. Sample size (162) was based on a threshold equivalence of 7% (α = 0.05, power = 80%). Inclusion criteria were: non-toxic, immunocompetent, 3 months to 18 years old, English-speaking patients with clinical or ultrasound identified skin abscesses who were not on antibiotics. Patients were block randomized to receive placebo or trimethoprim/sulfamethoxazole following incision and drainage. Follow-up was a call at 2-3 days & a repeat visit or call at 10-14 days. Treatment failure was defined as: persistent erythema, tenderness, and/or draining lesions. New lesion was defined as: primary resolution with development of new lesion (furuncle, carbuncle or abscess) at a different location. Compliance was evaluated by the return of the study medication or by patient report.
Interventions
DRUGTrimethoprim-sulfamethoxazole
Participants were randomized to receive placebo or trimethoprim/sulfamethoxazole using a computer randomization program on the initial presentation. The placebo is a Maalox and tonic water combination that resembled the antibiotic in color, texture and taste. The antibiotic dose is a standard trimethoprim/sulfamethoxazole for bacterial infection (10-12mg trimethoprim/kg/day, with a maximum adult dose of 160mg trimethoprim/day, divided into two doses). The concentration of the liquid is 200mg sulfamethoxazole/40mg trimethoprim per 5mL. With a maximum dose of 160mg trimethoprim, this equates to 20mL.
DRUGPlacebo group
Placebo (Maalox with simethicone and bitter mixture) suspension was dispensed to study participants who were block randomized to receive the placebo.
Sponsors
St. Louis University
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 18 Years
Healthy volunteers
No
Inclusion criteria
* non-toxic patients * immunocompetent patients * 3 months to 18 years old * English-speaking patients * skin abscesses * not on antibiotics
Exclusion criteria
* toxic patients * immunocompromising co-morbidities * less than 3 months old or older than 18 years of age * non-english speaking * on antibiotics
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Skin Abscess Resolution | 10-14 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| New Lesion Development and Spread of Skin Abscesses (on Subject) | 10-14 days and 3 month | The secondary outcomes of interest included the development of new lesions at a different site (\>5cm away from original skin abscess) on day 10 clinical follow-up or self-report and 3 month telephone follow-up. |
Countries
United States
Participant flow
Recruitment details
Patients \>3months and \<18 years old with skin abscesses who are not immunocompromised, or in 3rd trimester of pregnancy were approached to participate in the study, or allergic to trimethoprim/sulfamethoxazole.
Pre-assignment details
Enrolled participants were only excluded from the trial before assignment to groups if they left the emergency department prior to receiving the medication/placebo and further instructions.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Group Maalox and bitter mixture | 84 |
| Antibiotic Group Trimethoprim-sulfamethoxazole suspension | 77 |
| Total | 161 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 8 | 4 |
Baseline characteristics
| Characteristic | Antibiotic Group | Placebo Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 77 Participants | 84 Participants | 161 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 4.5 years STANDARD_DEVIATION 0.5 | 4.5 years STANDARD_DEVIATION 0.5 | 4.5 years STANDARD_DEVIATION 0.5 |
| Region of Enrollment United States | 77 participants | 84 participants | 161 participants |
| Sex: Female, Male Female | 30 Participants | 38 Participants | 68 Participants |
| Sex: Female, Male Male | 47 Participants | 46 Participants | 93 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 7 / 76 | 13 / 73 |
| serious Total, serious adverse events | 0 / 76 | 0 / 73 |
Outcome results
Primary
Skin Abscess Resolution
Time frame: 10-14 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Group | Skin Abscess Resolution | 4 participants |
| Antibiotic Group | Skin Abscess Resolution | 3 participants |
Secondary
New Lesion Development and Spread of Skin Abscesses (on Subject)
The secondary outcomes of interest included the development of new lesions at a different site (\>5cm away from original skin abscess) on day 10 clinical follow-up or self-report and 3 month telephone follow-up.
Time frame: 10-14 days and 3 month
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Group | New Lesion Development and Spread of Skin Abscesses (on Subject) | 15 participants |
| Antibiotic Group | New Lesion Development and Spread of Skin Abscesses (on Subject) | 13 participants |