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Prophylactic Antibiotic in Treatment of Fingertip Amputation

Sponsor
HaEmek Medical Center, Israel (Other)
Overall Status
Completed
CT.gov ID
NCT02077400
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
109
Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
The Use of Prophylactic Antibiotic in Treatment of Fingertip Amputation: A Randomized Prospective Trial
Study Start Date :
Jan 1, 2006
Actual Primary Completion Date :
Feb 1, 2015
Actual Study Completion Date :
Feb 1, 2015

Arms and Interventions

Arm Intervention/Treatment
No Intervention: no antibiotic
Active Comparator: Cephazolin

cefazoline

Drug: Cephazolin
Cephazolin
Other Names:
  • Cefamezine

    		•

    Outcome Measures

    Primary Outcome Measures

    1. infection rate [1 month]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 HaEmek medical center Afula Israel 18101

    Sponsors and Collaborators

    • HaEmek Medical Center, Israel

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    guy rubin, Dr., HaEmek Medical Center, Israel
    ClinicalTrials.gov Identifier:
    NCT02077400
    Other Study ID Numbers:
    • 0115-09-EMC
    First Posted:
    Mar 4, 2014
    Last Update Posted:
    Jul 10, 2015
    Last Verified:
    Jul 1, 2015
    Additional relevant MeSH terms:
    Cefazolin

    Study Results

    No Results Posted as of Jul 10, 2015