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Prophylactic Antibiotic in Treatment of Fingertip Amputation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02077400
First Posted: March 4, 2014
Last Update Posted: July 10, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
guy rubin, HaEmek Medical Center, Israel
  Purpose
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 Intervention
Infection Rate After Fingertip Amputation Drug: Cephazolin

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by guy rubin, HaEmek Medical Center, Israel:

Primary Outcome Measures:
  • infection rate [ Time Frame: 1 month ]

Enrollment: 60
Study Start Date: January 2006
Study Completion Date: February 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: no antibiotic
Active Comparator: Cephazolin
cefazoline
Drug: Cephazolin
Cephazolin
Other Name: Cefamezine

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02077400


Locations
Israel
HaEmek medical center
Afula, Israel, 18101
Sponsors and Collaborators
HaEmek Medical Center, Israel
  More Information

Responsible Party: guy rubin, Dr., HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT02077400     History of Changes
Other Study ID Numbers: 0115-09-EMC
First Submitted: March 2, 2014
First Posted: March 4, 2014
Last Update Posted: July 10, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
Anti-Bacterial Agents
Cefazolin
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents