Pediatric Fingertip Injuries:Are Antibiotics Required?
Information source: Children's Hospital Los Angeles
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: 1) Pediatric Patients and; 2) Injury to the Distal Fingertip
Intervention: Cepahlexin (drug) (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Children's Hospital Los Angeles Official(s) and/or principal investigator(s):
Caroline Altergott, MD, Principal Investigator, Affiliation: Children's Hospital Los Angeles
Summary
Study objective: Fingertip injuries are common in the pediatric population. Considerable
controversy exists about whether prophylactic antibiotics are necessary after repair of such
injuries. Our goals were to estimate the rate of bacterial infection among pediatric
patients with distal fingertip injuries overall and to compare the rate of bacterial
infections among subgroups treated with and without prophylactic antibiotics.
Methods: This was prospective randomized control study of pediatric patients presenting to
an urban children’s hospital with trauma to the distal fingertip requiring repair. Patients
were randomized to two groups: those receiving prophylactic antibiotics (Cephalexin) and
those who did not receive antibiotic therapy. Repairs were performed in a standardized
fashion and all patients were re-evaluated in the same emergency department in 48 hours and
by phone 7 days later. The primary outcome of this study was the incidence of infection.
Clinical Details
Study design: Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Incidence of infection in pediatric distal fingertip injuries that were treated with antibiotics and those that were not treated with antibiotics.
Eligibility
Minimum age: N/A.
Maximum age: 18 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- age 0-18 years
- fingertip injury distal to the distal interphalageal joint that requires repair
Exclusion Criteria:
- injury greater than 8 hours old
- diabetes
- oncologic disorder
- t-cell deficiency
- bleeding disorder
- chronic steriod use
- grossly contaminated wound
- allergy to Cephalexin
- current use of antibiotics
Locations and Contacts
Childrens Hospitla Los Angeles, Los Angeles, California 90027, United States
Additional Information
Last updated: March 6, 2006
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