A Phase 1 interventional study of The GPS™ II Platelet Concentrate Separation Kit in Coronary Heart Failure, sponsored by Zimmer Biomet. Completed at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-19.
Sponsored by Zimmer Biomet · Phase 1, Interventional, and Treatment
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.
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.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 140 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.
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Of its 23 completed or terminated interventional studies of FDA-regulated products, 19 (83%) have results posted.
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Exclusion Criteria:
The arm utilizes the GPS™ II Platelet Concentrate Separation Kit.
Device: The GPS™ II Platelet Concentrate Separation Kit
This arm utilizes standard leg wound closure procedures.
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.
Presence/absence of leg wound infection, General wound healing - picture evaluation
Time frame: 6 weeks
ASEPSIS Score, Length of hospital stay, Reoperation rate for bleeding and infection control
Time frame: 6 weeks
Plan to share: No
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Zimmer Biomet