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Withdrawn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Withdrawn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