Prophylactic Antibiotic in Treatment of Fingertip Amputation

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. Identifier: NCT02077400
Recruitment Status : Completed
First Posted : March 4, 2014
Last Update Posted : July 10, 2015
Information provided by (Responsible Party):
guy rubin, HaEmek Medical Center, Israel

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
Infection Rate After Fingertip Amputation Drug: Cephazolin Not Applicable

Study Type : Interventional  (Clinical Trial)
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 : January 2006
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics
U.S. FDA Resources

Arm Intervention/treatment
No Intervention: no antibiotic
Active Comparator: Cephazolin
Drug: Cephazolin
Other Name: Cefamezine

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

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

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.

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 identifier (NCT number): NCT02077400

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

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

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