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

Primary Purpose

Hand Laceration, Tendon Involved, Clean Laceration

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Antibiotic-Cefamezin
Sponsored by
HaEmek Medical Center, Israel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hand Laceration focused on measuring Lacerations, Tendons, Antobiotic

Eligibility Criteria

13 Years - 75 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnant
  • Children
  • Immunocompremised patients
  • "Dirty" lacerations

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    with antibiotic and without antibiotic

    Arm Description

    Outcomes

    Primary Outcome Measures

    rate of wound infections
    signs of wound/tissue infection, levels of WBC, ESR, CRP

    Secondary Outcome Measures

    Full Information

    First Posted
    July 11, 2013
    Last Updated
    February 12, 2020
    Sponsor
    HaEmek Medical Center, Israel
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01899781
    Brief Title
    Prophylactic Antibiotic Treatment for Hand Lacerations Involving Flexor and/or Extensor Tendon
    Official Title
    Prophylactic Antibiotic Treatment for Hand Lacerations Involving Flexor and/or Extensor Tendon
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2013 (Actual)
    Primary Completion Date
    January 2015 (Actual)
    Study Completion Date
    November 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    HaEmek Medical Center, Israel

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hand Laceration, Tendon Involved, Clean Laceration, No Bone Involved
    Keywords
    Lacerations, Tendons, Antobiotic

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    24 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    with antibiotic and without antibiotic
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Antibiotic-Cefamezin
    Other Intervention Name(s)
    Ceforal, Keflex
    Primary Outcome Measure Information:
    Title
    rate of wound infections
    Description
    signs of wound/tissue infection, levels of WBC, ESR, CRP
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    13 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Hand laceration Tendon involeved Clean laceration No bone involved Exclusion Criteria: Pregnant Children Immunocompremised patients "Dirty" lacerations

    12. IPD Sharing Statement

    Learn more about this trial

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

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