Evaluate Use of Gravitational Platelet Separation System on Leg Wound Healing in Coronary Bypass Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Clinical Study to Evaluate the Use of Gravitational Platelet Separation System on Leg Wound Healing in Coronary Bypass Surgery

Conditions
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Coronary Heart Failure

Intervention / Treatment
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* Device: The GPS™ II Platelet Concentrate Separation Kit


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>The arm utilizes the GPS™ II Platelet Concentrate Separation Kit. | Device: The GPS™ II Platelet Concentrate Separation Kit<br>* 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.<br>|
| No Intervention: B<br>This arm utilizes standard leg wound closure procedures. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence/absence of leg wound infection, General wound healing - picture evaluation |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ASEPSIS Score, Length of hospital stay, Reoperation rate for bleeding and infection control |  | 6 weeks |