Pediatric Fingertip Injuries:Are Antibiotics Required?

This study has been completed.
Sponsor:
Information provided by:
Children's Hospital Los Angeles
ClinicalTrials.gov Identifier:
NCT00300092
First received: March 6, 2006
Last updated: NA
Last verified: January 2005
History: No changes posted
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Children's Hospital Los Angeles:

Primary Outcome Measures:
  • Incidence of infection in pediatric distal fingertip injuries that were treated with antibiotics and those that were not treated with antibiotics.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00300092

Locations
United States, California
Childrens Hospitla Los Angeles
Los Angeles, California, United States, 90027
Sponsors and Collaborators
Children's Hospital Los Angeles
Investigators
Principal Investigator: Caroline Altergott, MD Children's Hospital Los Angeles
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00300092     History of Changes
Other Study ID Numbers: CCI 99.156
Study First Received: March 6, 2006
Last Updated: March 6, 2006
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Wounds and Injuries

ClinicalTrials.gov processed this record on August 28, 2014