Prophylactic Antibiotic in Treatment of Fingertip Amputation

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by HaEmek Medical Center, Israel
Sponsor:
Information provided by (Responsible Party):
guy rubin, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT02077400
First received: March 2, 2014
Last updated: March 3, 2014
Last verified: March 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 HaEmek Medical Center, Israel:

Primary Outcome Measures:
  • infection rate [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: January 2006
Estimated Primary Completion Date: May 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02077400

Contacts
Contact: guy rubin, MD 972-4-6494300

Locations
Israel
HaEmek medical center Recruiting
Afula, Israel, 18101
Contact: guy rubin, MD         
Principal Investigator: guy rubin, MD         
Sponsors and Collaborators
HaEmek Medical Center, Israel
  More Information

No publications provided

Responsible Party: guy rubin, Dr., HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT02077400     History of Changes
Other Study ID Numbers: 0115-09-EMC
Study First Received: March 2, 2014
Last Updated: March 3, 2014
Health Authority: Israel: HaEmek medical center, helsinki board

Additional relevant MeSH terms:
Anti-Bacterial Agents
Cefazolin
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on July 22, 2014