Pediatric Fingertip Injuries:Are Antibiotics Required?
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pediatric Fingertip Injuries: Do Prophylactic Antibiotics Alter Infection Rates?|
- Pediatric Fingertip Injuries Do Prophylactic Antibiotics Alter Infection Rates [ Time Frame: 4 years ] [ Designated as safety issue: No ]Incidence of infection in pediatric distal fingertip injuries that were treated with antibiotics and those that were not treated with antibiotics.
|Study Start Date:||September 2000|
|Study Completion Date:||July 2004|
|Primary Completion Date:||July 2004 (Final data collection date for primary outcome measure)|
No Intervention: No antibioitcs
Group 1 received no antibiotics
Active Comparator: Cephalexin
Group 2 received cephalexin at 50 mg/kg divided 3 times daily for 7 days
Drug: Cepahlexin (drug)
Cephalexin 50 mg/kg divided 3 times daily for 7 days
Other Name: keflex
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00300092
|United States, California|
|Childrens Hospitla Los Angeles|
|Los Angeles, California, United States, 90027|
|Principal Investigator:||Caroline Altergott, MD||Children's Hospital Los Angeles|