- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00517452
Platelet Rich Plasma Study in Lower Extremity Bypass Surgery (PRP)
January 4, 2011 updated by: Lawson Health Research Institute
Phase 2-3 Observational Wound Care Study Comparing Application of Platelet Rich Plasma With Standard of Care Wound Closure in Vascular Patients Requiring a Groin Incision.
The use of platelet rich plasma will decrease wound infection postop.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
81
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Vascular surgical patients scheduled for elective lower extremity bypass surgery,aortoiliac revascularizations and endovascular AAA repair requiring a groin incision
Description
Inclusion Criteria:
- Vascular surgical patients scheduled for elective lower extremity bypass surgery,aortoiliac revascularizations and endovascular AAA repair requiring a groin incision Exclusion Criteria:Patients requiring emergent procedures, unable to give informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
Platelet Rich Plasma
Group received platelet rich plasma and observed over a period of 30 days or until wound closure
|
Standard Wound Care
Group was treated as per standard care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Wound healing
Time Frame: 4- 6 weeks post op
|
4- 6 weeks post op
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Kirk D Lawlor, London Health Sciences Centre, University of Western Ontario
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2007
Study Completion (Actual)
December 1, 2007
Study Registration Dates
First Submitted
August 16, 2007
First Submitted That Met QC Criteria
August 16, 2007
First Posted (Estimate)
August 17, 2007
Study Record Updates
Last Update Posted (Estimate)
January 5, 2011
Last Update Submitted That Met QC Criteria
January 4, 2011
Last Verified
January 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R-07-098
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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