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

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver), Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: January 2010

Intervention(s) in this Clinical Trial

• Device: The GPS™ II Platelet Concentrate Separation Kit
  • 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.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
  • The arm utilizes the GPS™ II Platelet Concentrate Separation Kit.
• No Intervention: B
  • This arm utilizes standard leg wound closure procedures.

Primary Measures

• Presence/absence of leg wound infection, General wound healing - picture evaluation
  • Time Frame: 6 weeks
    Safety Issue?: Yes

Secondary Measures

• ASEPSIS Score, Length of hospital stay, Reoperation rate for bleeding and infection control
  • Time Frame: 6 weeks
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Biomet Norge A.S.

Overall Clinical Trial Officials and Contacts

Christian Fredrik Stray, B. Sc, MBA Principal Investigator Biomet Norge A.S.  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00514241

Study ID Number: JA-250-N

ClinicalTrials.gov Identifier: NCT00514241

Health Authority: Norway: The National Committees for Research Ethics in Norway