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

Coronary Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00514241
• Other study ID #: JA-250-N
• Status: Completed
• Phase: Phase 1
• First received: August 8, 2007
• Last updated: May 17, 2017
• Start date: January 2006
• Est. completion date: August 2008

Study information

• Verified date: May 2017
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Heart Failure
• Heart Failure

Intervention

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.

Locations

Country	Name	City	State
Norway	Feiringklinikken AS	Feiring

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence/absence of leg wound infection, General wound healing - picture evaluation		6 weeks
Secondary	ASEPSIS Score, Length of hospital stay, Reoperation rate for bleeding and infection control		6 weeks