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

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ClinicalTrials.gov Identifier: NCT01899781
Recruitment Status : Unknown
Verified July 2013 by HaEmek Medical Center, Israel.
Recruitment status was:  Not yet recruiting
First Posted : July 15, 2013
Last Update Posted : July 15, 2013
Sponsor:
Information provided by (Responsible Party):
HaEmek Medical Center, Israel

Study Description
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Brief Summary:
The investigators assume that simple hand lacerations involving flexors or extensors tendons, do not require prophylactic antibiotic treatment to prevent wound infection.

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

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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
Study Start Date : August 2013
Estimated Primary Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Tears
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: with antibiotic and without antibiotic Drug: Antibiotic-Cefamezin
Other Names:
  • Ceforal
  • Keflex


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


Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

No Contacts or Locations Provided
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT01899781     History of Changes
Other Study ID Numbers: EMC-003812-CTIL
First Posted: July 15, 2013    Key Record Dates
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