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:
Information provided by:
University of Nebraska
ClinicalTrials.gov Identifier:
NCT00672672
First received: May 2, 2008
Last updated: August 2, 2011
Last verified: August 2011
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   19 Years to 90 Years
Genders Eligible for Study:   Both
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
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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00672672

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

No publications provided

Responsible Party: Ali Khoynezhad, MD, Univaersity of Nebraska Medical Center
ClinicalTrials.gov Identifier: NCT00672672     History of Changes
Other Study ID Numbers: 065-08
Study First Received: May 2, 2008
Last Updated: August 2, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 24, 2014