Phase 3
N=23
Management of Skin and Soft Tissue Abscesses in Pediatric Patients After Incision and Drainage
Abscess
Bottom Line
View on ClinicalTrials.gov: NCT00691600 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcome: Primary: Number of Participants With Abscess Resolution — 11; 9 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- oral trimethoprim/sulfamethoxazole (Drug); Placebo (Drug)
- Age
- Pediatric, Adult · 0+ yrs
- Sex
- All
- Sponsor
- Baylor College of Medicine
- Primary completion
- Apr 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Abscess Resolution |
11; 9 | — |
| SECONDARY Number of Participants Requiring Admission for Failure of Abscess Resolution |
0; 0 | — |
| SECONDARY Number of Participants Requiring New or Modified Antibiotics for Failure of Abscess to Resolve |
1; 2 | — |
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.
Eligibility Criteria
Inclusion Criteria
1.) Abscess 90 days and 10 days), etc.
- 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.
Data sourced from ClinicalTrials.gov (NCT00691600). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.