Autologous Platelet Gel in Wound Healing of Coronary Artery Bypass Grafting (CABG) Patients - Full Text View

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

This study is not yet open for participant recruitment.
Verified by University of Nebraska, May 2008

Sponsored by:	University of Nebraska
Information provided by:	University of Nebraska
ClinicalTrials.gov Identifier:	NCT00672672

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 III

MedlinePlus related topics:

Coronary Artery Bypass Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study

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

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:	August 2008
Estimated Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
II: Experimental 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

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

Contacts


Contact: Tracy Rheult, BS	402-559-4424	trheault@unmc.edu

Locations


United States, Nebraska
	University of Nebraska Medical Center
	Omaha, Nebraska, United States, 68198

Sponsors and Collaborators

University of Nebraska

More Information

Responsible Party:	Univaersity of Nebraska Medical Center ( Ali Khoynezhad, MD )
Study ID Numbers:	IRB065-08
First Received:	May 2, 2008
Last Updated:	May 5, 2008
ClinicalTrials.gov Identifier:	NCT00672672
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Nebraska:

Wound healing of surgical site treated with autologous platlet gel

Additional relevant MeSH terms:

Infection

ClinicalTrials.gov processed this record on October 24, 2008