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Prophylactic Antibiotic Treatment for Hand Lacerations Involving Flexor and/or Extensor Tendon

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2013 by HaEmek Medical Center, Israel.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01899781
First Posted: July 15, 2013
Last Update Posted: July 15, 2013
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):
HaEmek Medical Center, Israel
  Purpose
The investigators assume that simple hand lacerations involving flexors or extensors tendons, do not require prophylactic antibiotic treatment to prevent wound infection.

Condition Intervention Phase
Hand Laceration Tendon Involved Clean Laceration No Bone Involved Drug: Antibiotic-Cefamezin Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prophylactic Antibiotic Treatment for Hand Lacerations Involving Flexor and/or Extensor Tendon

Resource links provided by NLM:


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

Primary Outcome Measures:
  • rate of wound infections [ Time Frame: 2 years ]
    signs of wound/tissue infection, levels of WBC, ESR, CRP


Estimated Enrollment: 60
Study Start Date: August 2013
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: with antibiotic and without antibiotic Drug: Antibiotic-Cefamezin
Other Names:
  • Ceforal
  • Keflex

Detailed Description:

Hand lacerations are divided to "complicated" which involves tendons, nerves, bones, and joints, and "simple" which involves only cutaneous and subcutaneous tissue.

prophylactic antibiotic should not be given in a clean simple lacerations, and should be given when a bone is involve (open fracture). But there is not enough data, weather prophylactic antibiotic treatment should be given when only tendons are involved. The investigators will examine 2 groups of 30 patients each with clean hand lacerations involving tendons. One group will be treated with prophylactic antibiotic and the other wont be treated, randomly. The investigators assume that the rate of wound infection wont be different between the 2 groups.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Hand laceration
  • Tendon involeved
  • Clean laceration
  • No bone involved

Exclusion Criteria:

  • Pregnant
  • Children
  • Immunocompremised patients
  • "Dirty" lacerations
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT01899781     History of Changes
Other Study ID Numbers: EMC-003812-CTIL
First Submitted: July 11, 2013
First Posted: July 15, 2013
Last Update Posted: July 15, 2013
Last Verified: July 2013

Keywords provided by HaEmek Medical Center, Israel:
Lacerations
Tendons
Antobiotic

Additional relevant MeSH terms:
Lacerations
Wounds and Injuries
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents