Clinical Trial: Pediatric Fingertip Injuries:Are Antibiotics Required?

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Pediatric Fingertip Injuries: Do Prophylactic Antibiotics Alter Infection Rates?

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.

Detailed Summary:

MATERIAL and METHODS Study design, Setting and Selection of Participants

This prospective randomized control trial was conducted at an urban children's hospital Emergency Department with 56,000 visits annually. The Institutional Review Board (IRB) approved the study prior to subject enrollment. The study period was from September 2000 to July 2004. All patients under 18 years of age presenting to the Emergency Department with a fingertip injury distal to the distal interphalangeal joint were eligible to participate. Patients were excluded from the study if the time from injury to repair was greater than eight hours, if the patients had diabetes, an oncologic disorder, an immune deficiency, a bleeding disorder, used steroids regularly, presented with a grossly contaminated wound, were currently taking antibiotics, or had a previous allergic reaction to cephalosporins.

The study was formulated as an equivalence trial to demonstrate non-inferiority of repair without versus with prophylactic antibiotics. The rate of infection 7 days after repair was the primary outcome variable. Determination of the target sample size was based on a combination of practicality and maximum difference between infection rates consistent with equivalence. It was judged feasible to enroll 160 subjects over the course of the study. Sample sizes of 80 per group would have 80% power to conclude with 95% certainty that the infection rates in the two groups were equivalent. This calculation is based on an upper 1-sided 95% confidence limit for the difference in infection rates, with percent infected of 6.25% in both groups, and the maximum allowable difference resulting in equivalence to be 10.6%.

Intervention

All wounds were treated following a standardi
Sponsor: Children's Hospital Los Angeles

Current Primary Outcome: Pediatric Fingertip Injuries Do Prophylactic Antibiotics Alter Infection Rates [ Time Frame: 4 years ]

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

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Children's Hospital Los Angeles

Dates:
Date Received: March 6, 2006
Date Started: September 2000
Date Completion:
Last Updated: April 16, 2015
Last Verified: April 2015