Clinical trial NCT00691600: Management of Skin and Soft Tissue Abscesses in Pediatric Patients After Incision and Drainage
Official title: Phase 3 Study Comparing Bactrim to Placebo in the Management of Abscesses < 5cm in the Pediatric Population.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Abscess
Keywords: abscess
Abscesses in the pediatric emergency population
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2008-06-05
Enrollment: 23
Sex: ALL
Minimum age (years): 90
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Abscess Resolution
timeFrame: 10 days
Secondary outcomes:
measure: Number of Participants Requiring Admission for Failure of Abscess Resolution
timeFrame: 10 days
measure: Number of Participants Requiring New or Modified Antibiotics for Failure of Abscess to Resolve
timeFrame: 10 days
Other outcomes:
Locations:
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Andrea Cruz, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: