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

This study has been terminated.
(Study closed with no subjects accrued. PI decided to stop study.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00672672
First Posted: May 6, 2008
Last Update Posted: August 3, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Nebraska
  Purpose
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

Condition Intervention Phase
Wounds Infection Biological: autologous platelet gel Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Autologous Platelet Gel in Wound Healing of Coronary Artery Bypass Grafting (CABG) Patients

Resource links provided by NLM:


Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • The surgical sites will be assessed for degree of healing and signs and symptoms of infection on postop days one and three and during the patients' follow up visits in the clinic. [ Time Frame: 30 days ]

Estimated Enrollment: 250
Study Start Date: February 2009
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: II
Patients who do not receive platlet gel.
Biological: autologous platelet gel
Patients will receive APG to the surgical site in the operating room. The control site will receive no treatment.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00672672


Locations
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Sponsors and Collaborators
University of Nebraska
  More Information

Responsible Party: Ali Khoynezhad, MD, Univaersity of Nebraska Medical Center
ClinicalTrials.gov Identifier: NCT00672672     History of Changes
Other Study ID Numbers: 065-08
First Submitted: May 2, 2008
First Posted: May 6, 2008
Last Update Posted: August 3, 2011
Last Verified: August 2011

Keywords provided by University of Nebraska:
Wound healing of surgical site treated with autologous platlet gel

Additional relevant MeSH terms:
Wounds and Injuries