Prophylactic Antibiotic in Treatment of Fingertip Amputation

July 9, 2015 updated by: guy rubin, HaEmek Medical Center, Israel

The Use of Prophylactic Antibiotic in Treatment of Fingertip Amputation: A Randomized Prospective Trial

Fingertip amputation is a common injury. Considerable controversy exists as to whether prophylactic antibiotics are necessary for this injury. The investigators goal was to compare the rate of infections among subgroups with and without prophylactic antibiotic treatment. The study hypothesis was that infection rates were similar in the two groups.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Afula, Israel, 18101
        • HaEmek Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • fingertip amputation with bone exposed

Exclusion Criteria:

  • under the age of 18 years
  • if the patient had diabetes
  • oncological disorder
  • immune deficiency
  • bleeding disorder
  • used steroids regularly
  • presented with a grossly contaminated wound or other injury requiring antibiotic treatment
  • were currently taking antibiotics, or had a previous allergic reaction to cephalosporins.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: no antibiotic
Active Comparator: Cephazolin
cefazoline
Drug: Cephazolin
Cephazolin
Other Names:
  • Cefamezine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
infection rate
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HaEmek Medical Center, Israel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

March 2, 2014

First Submitted That Met QC Criteria

March 3, 2014

First Posted (Estimate)

March 4, 2014

Study Record Updates

Last Update Posted (Estimate)

July 10, 2015

Last Update Submitted That Met QC Criteria

July 9, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0115-09-EMC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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