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

Condition(s) targeted: Coronary Heart Failure

Intervention: The GPS™ II Platelet Concentrate Separation Kit (Device)

Phase: Phase 1

Status: Recruiting

Sponsored by: Biomet Norge A.S.

Official(s) and/or principal investigator(s):
Christian Fredrik Stray, B. Sc, MBA, Principal Investigator, Affiliation: Biomet Norge A.S.

Overall contact:
Sven M Almdahl, M.D., Phone: +4763924400, Email: sven.martin.almdahl@feiringklinikken.no

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

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

Primary outcome: Presence/absence of leg wound infection, General wound healing - picture evaluation

Secondary outcome: ASEPSIS Score, Length of hospital stay, Reoperation rate for bleeding and infection control

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Sven M Almdahl, M.D., Phone: +4763924400, Email: sven.martin.almdahl@feiringklinikken.no

Feiringklinikken AS, Feiring, Norway; Recruiting

Starting date: January 2008
Ending date: January 2011
Last updated: June 16, 2008