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| Sponsor: | Children's Hospital Los Angeles |
|---|---|
| Information provided by: | Children's Hospital Los Angeles |
| ClinicalTrials.gov Identifier: | NCT00300092 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
1) Pediatric Patients and 2) Injury to the Distal Fingertip |
Drug: Cepahlexin (drug) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study |
Eligibility| Ages Eligible for Study: | up to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| Childrens Hospitla Los Angeles | |
| Los Angeles, California, United States, 90027 | |
| Principal Investigator: | Caroline Altergott, MD | Children's Hospital Los Angeles |
More Information
| Study ID Numbers: | CCI 99.156 |
| Study First Received: | March 6, 2006 |
| Last Updated: | March 6, 2006 |
| ClinicalTrials.gov Identifier: | NCT00300092 History of Changes |
| Health Authority: | United States: Institutional Review Board |