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Autologous Platelet Gel in Wound Healing of Coronary Artery Bypass Grafting (CABG) Patients

Primary Purpose

Wounds, Infection

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
autologous platelet gel
Sponsored by
University of Nebraska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Wounds focused on measuring surgical site healing treated with autologous platlet gel

Eligibility Criteria

19 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Any patient who meets criteria and consents to undergo a CABG procedure involving conduit sites and consents to this study.

Exclusion Criteria:

  • Any patient, after inclusion, whom is later determined to have had on-going therapy that could influence wound healing such as radiation or chemotherapy, extensive steroid use, or accidental trauma such as burns, etc.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Platelet Gel

    Control (No platelet gel)

    Arm Description

    Participants receive platlet gel.

    Participants do not receive platlet gel.

    Outcomes

    Primary Outcome Measures

    Healing and infection of surgical sites
    The surgical sites will be assessed for degree of healing and signs and symptoms of infection on post-op days one and three and during the patients' follow up visits in the clinic.

    Secondary Outcome Measures

    Full Information

    First Posted
    May 2, 2008
    Last Updated
    August 11, 2023
    Sponsor
    University of Nebraska
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00672672
    Brief Title
    Autologous Platelet Gel in Wound Healing of Coronary Artery Bypass Grafting (CABG) Patients
    Official Title
    Autologous Platelet Gel in Wound Healing of Coronary Artery Bypass Grafting (CABG) Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Study closed with no subjects accrued. PI decided to stop study.
    Study Start Date
    January 13, 2009 (Actual)
    Primary Completion Date
    January 6, 2010 (Actual)
    Study Completion Date
    January 6, 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Nebraska

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study will determine if autologous platelet gel (APG) on sternal incision and conduit sites will improve wound healing and decrease infection in coronary artery bypass grafting surgery patients.
    Detailed Description
    The purpose of this study is to determine if the use of autologous platelet gel (APG) on sternal incision and conduit sites will improve wound healing and decrease the incidence of infection in patients undergoing coronary artery bypass grafting surgery

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Wounds, Infection
    Keywords
    surgical site healing treated with autologous platlet gel

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Platelet Gel
    Arm Type
    Experimental
    Arm Description
    Participants receive platlet gel.
    Arm Title
    Control (No platelet gel)
    Arm Type
    Placebo Comparator
    Arm Description
    Participants do not receive platlet gel.
    Intervention Type
    Biological
    Intervention Name(s)
    autologous platelet gel
    Intervention Description
    Patients will receive APG to the surgical site in the operating room. The control site will receive no treatment.
    Primary Outcome Measure Information:
    Title
    Healing and infection of surgical sites
    Description
    The surgical sites will be assessed for degree of healing and signs and symptoms of infection on post-op days one and three and during the patients' follow up visits in the clinic.
    Time Frame
    30 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Any patient who meets criteria and consents to undergo a CABG procedure involving conduit sites and consents to this study. Exclusion Criteria: Any patient, after inclusion, whom is later determined to have had on-going therapy that could influence wound healing such as radiation or chemotherapy, extensive steroid use, or accidental trauma such as burns, etc.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ali Khoynezhad, MD
    Organizational Affiliation
    University of Nebraska
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Autologous Platelet Gel in Wound Healing of Coronary Artery Bypass Grafting (CABG) Patients

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