Pediatric Fingertip Injuries:Are Antibiotics Required?
Pediatric Fingertip Injuries: Do Prophylactic Antibiotics Alter Infection Rates?
1 other identifier
interventional
146
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2000
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2004
CompletedFirst Submitted
Initial submission to the registry
March 6, 2006
CompletedFirst Posted
Study publicly available on registry
March 8, 2006
CompletedApril 20, 2015
April 1, 2015
3.8 years
March 6, 2006
April 16, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Pediatric Fingertip Injuries Do Prophylactic Antibiotics Alter Infection Rates
Incidence of infection in pediatric distal fingertip injuries that were treated with antibiotics and those that were not treated with antibiotics.
4 years
Study Arms (2)
No antibioitcs
NO INTERVENTIONGroup 1 received no antibiotics
Cephalexin
ACTIVE COMPARATORGroup 2 received cephalexin at 50 mg/kg divided 3 times daily for 7 days
Interventions
Cephalexin 50 mg/kg divided 3 times daily for 7 days
Eligibility Criteria
You may qualify if:
- age 0-18 years
- fingertip injury distal to the distal interphalageal joint that requires repair
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Childrens Hospitla Los Angeles
Los Angeles, California, 90027, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Caroline Altergott, MD
Children's Hospital Los Angeles
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Pediatrics
Study Record Dates
First Submitted
March 6, 2006
First Posted
March 8, 2006
Study Start
September 1, 2000
Primary Completion
July 1, 2004
Study Completion
July 1, 2004
Last Updated
April 20, 2015
Record last verified: 2015-04