Pediatric Fingertip Injuries:Are Antibiotics Required?

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Caroline Altergott, Children's Hospital Los Angeles
ClinicalTrials.gov Identifier:
NCT00300092
First received: March 6, 2006
Last updated: April 16, 2015
Last verified: April 2015
  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
Finger Injuries
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
Official Title: Pediatric Fingertip Injuries: Do Prophylactic Antibiotics Alter Infection Rates?

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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.


Enrollment: 146
Study Start Date: September 2000
Study Completion Date: July 2004
Primary Completion Date: July 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  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

Responsible Party: Caroline Altergott, Assistant Professor of Pediatrics, Children's Hospital Los Angeles
ClinicalTrials.gov Identifier: NCT00300092     History of Changes
Other Study ID Numbers: CCI 99.156
Study First Received: March 6, 2006
Last Updated: April 16, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Finger Injuries
Hand Injuries
Wounds and Injuries
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on August 27, 2015