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

History of Changes

Tracking Information
First Received Date ^ICMJE	May 2, 2008
Last Updated Date	August 2, 2011
Start Date ^ICMJE	February 2009
Estimated Primary Completion Date	July 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 5, 2008)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00672672 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Autologous Platelet Gel in Wound Healing of Coronary Artery Bypass Grafting (CABG) Patients
Official Title ^ICMJE	Autologous Platelet Gel in Wound Healing of Coronary Artery Bypass Grafting (CABG) Patients
Brief Summary	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
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
Condition ^ICMJE	Wounds Infection
Intervention ^ICMJE	Biological: autologous platelet gel Patients will receive APG to the surgical site in the operating room. The control site will receive no treatment.
Study Arm (s)	Experimental: II Patients who do not receive platlet gel. Intervention: Biological: autologous platelet gel
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Estimated Enrollment ^ICMJE	250
Completion Date	Not Provided
Estimated Primary Completion Date	July 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	19 Years to 90 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00672672
Other Study ID Numbers ^ICMJE	065-08
Has Data Monitoring Committee	Yes
Responsible Party	Ali Khoynezhad, MD, Univaersity of Nebraska Medical Center
Study Sponsor ^ICMJE	University of Nebraska
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University of Nebraska
Verification Date	August 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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