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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2013 by HaEmek Medical Center, Israel
Sponsor:
Information provided by (Responsible Party):
HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT01899781
First received: July 11, 2013
Last updated: July 12, 2013
Last verified: July 2013
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   13 Years to 75 Years
Genders Eligible for Study:   Both
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
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.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT01899781     History of Changes
Other Study ID Numbers: EMC-003812-CTIL
Study First Received: July 11, 2013
Last Updated: July 12, 2013
Health Authority: Israel: Ethics Commission

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
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014