AtherosclerosisPRPNCT00517452
Platelet Rich Plasma Study in Lower Extremity Bypass Surgery
An observational study of Atherosclerosis, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
Trial summary
The use of platelet rich plasma will decrease wound infection postop. Read more about this study
- Who is it for?
- Ages 35 to 90 years
- Conditions the study is for
- Atherosclerosis
- How many people
- 81 participants
- Where
- No sites listed yet
- Study dates
- May 2007to Dec 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Vascular surgical patients scheduled for elective lower extremity bypass surgery,aortoiliac revascularizations and endovascular AAA repair requiring a groin incision
Who may be able to join
- 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
Who cannot join
None listed.
About this study
Official title: 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.
- Conditions
- Atherosclerosis
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Wound healing
Measured: 4- 6 weeks post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2007 (estimated)
- Study startMay 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- Zimmer Biomet
- Investigators
- Kirk D Lawlor, Principal investigator, London Health Sciences Centre, University of Western Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00517452
- Sponsor's protocol ID
- R-07-098
- Acronym
- PRP
- Status last verified
- Jan 2011
- First submitted
- 16 Aug 2007
- Last updated
- 5 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT00517452
- Acronym / sponsor ID
- PRP / R-07-098
- Conditions
- Atherosclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Zimmer Biomet
- Study start
- May 2007
- Study completion
- Dec 2007 (actual)
- First posted
- 17 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The use of platelet rich plasma will decrease wound infection postop.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 35 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Vascular surgical patients scheduled for elective lower extremity bypass surgery,aortoiliac revascularizations and endovascular AAA repair requiring a groin incision
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Wound healing
Time frame: 4- 6 weeks post op
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirk D Lawlor principal investigator
London Health Sciences Centre, University of Western Ontario
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerosis, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound healing (time frame: 4- 6 weeks post op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2011.