Evaluate Use of Gravitational Platelet Separation System on Leg Wound Healing in Coronary Bypass Surgery
Primary Purpose
Coronary Heart Failure
Status
Completed
Phase
Phase 1
Locations
Norway
Study Type
Interventional
Intervention
The GPS™ II Platelet Concentrate Separation Kit
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Heart Failure
Eligibility Criteria
Inclusion Criteria:
- Patient undergoing a cardiothoracic procedure requiring a leg vein harvest
- Patient signature of informed consent form
Exclusion Criteria:
- Pregnancy
- < 18 years of age
- History of amenia (hemoglobin < 11.0)
- History of bleeding disorder
- Un-cooperative patient or patient with neurological disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations
- Hypothyroidism
- History of any blood disorder
- Patient with an active infection
- Patients taking Cox II inhibitors.
- Heparin-induced thrombocytopenia
Sites / Locations
- Feiringklinikken AS
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
A
B
Arm Description
The arm utilizes the GPS™ II Platelet Concentrate Separation Kit.
This arm utilizes standard leg wound closure procedures.
Outcomes
Primary Outcome Measures
Presence/absence of leg wound infection, General wound healing - picture evaluation
Secondary Outcome Measures
ASEPSIS Score, Length of hospital stay, Reoperation rate for bleeding and infection control
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00514241
Brief Title
Evaluate Use of Gravitational Platelet Separation System on Leg Wound Healing in Coronary Bypass Surgery
Official Title
A Clinical Study to Evaluate the Use of Gravitational Platelet Separation System on Leg Wound Healing in Coronary Bypass Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zimmer Biomet
4. Oversight
5. Study Description
Brief Summary
The aim of platelet rich plasma (PRP) application is to accelerate the healing cascade via application of elevated cytokine concentrations released during platelet degranulation.
This is a prospective randomized study of the effect of autologous platelet concentrate application during surgical closure following a vein harvest during coronary bypass surgery. This prophylactic measure will be compared to standard surgical closure techniques with the primary outcome being the incidence of leg wound infection.
Detailed Description
Postoperative wound disturbances, particularly surgical site infection of the chest and leg incision site following cardiac surgery are associated with increased morbidity, mortality, and costs. A recent dissertation from the National hospital in Norway showed a 20% infection rate in wounds after bypass surgery, this is probably representable nation wide. Prophylactic interventions that reduce postoperative wound disturbances and infection would have inherent value in cardiothoracic surgery. Ideally, a specific intervention would demonstrate improved patient outcomes while reducing the output of hospital resources.
The aim of platelet rich plasma (PRP) application is to accelerate the healing cascade via application of elevated cytokine concentrations released during platelet degranulation. It is hypothesized that the elevated cytokine levels will elucidate an accelerated healing response of the affected tissue. PPP application has also been advocated as a tissue sealant for topical hemostasis.
This is a prospective randomized study of the effect of autologous platelet concentrate application during surgical closure following a vein harvest during coronary bypass surgery. This prophylactic measure will be compared to standard surgical closure techniques with the primary outcome being the incidence of leg wound infection.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
The arm utilizes the GPS™ II Platelet Concentrate Separation Kit.
Arm Title
B
Arm Type
No Intervention
Arm Description
This arm utilizes standard leg wound closure procedures.
Intervention Type
Device
Intervention Name(s)
The GPS™ II Platelet Concentrate Separation Kit
Intervention Description
The GPS™ II Platelet Concentrate Separation Kit system is designed to be used for the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a small sample of blood at the patient's point of care. The PRP can be mixed with autograft and allograft bone prior to application to an orthopedic surgical site as deemed necessary by the clinical use requirements.
Primary Outcome Measure Information:
Title
Presence/absence of leg wound infection, General wound healing - picture evaluation
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
ASEPSIS Score, Length of hospital stay, Reoperation rate for bleeding and infection control
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient undergoing a cardiothoracic procedure requiring a leg vein harvest
Patient signature of informed consent form
Exclusion Criteria:
Pregnancy
< 18 years of age
History of amenia (hemoglobin < 11.0)
History of bleeding disorder
Un-cooperative patient or patient with neurological disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations
Hypothyroidism
History of any blood disorder
Patient with an active infection
Patients taking Cox II inhibitors.
Heparin-induced thrombocytopenia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Fredrik Stray, B. Sc, MBA
Organizational Affiliation
Biomet Norge A.S.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Feiringklinikken AS
City
Feiring
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluate Use of Gravitational Platelet Separation System on Leg Wound Healing in Coronary Bypass Surgery
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