Text Size

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biomet, Inc. ( Biomet Norge A.S. )
ClinicalTrials.gov Identifier:
NCT00514241
First received: August 8, 2007
Last updated: December 5, 2011
Last verified: December 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Coronary Heart Failure
 Device: The GPS™ II Platelet Concentrate Separation Kit
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: A Clinical Study to Evaluate the Use of Gravitational Platelet Separation System on Leg Wound Healing in Coronary Bypass Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:
  • Presence/absence of leg wound infection, General wound healing - picture evaluation [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • ASEPSIS Score, Length of hospital stay, Reoperation rate for bleeding and infection control [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 140
Study Start Date: January 2006
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
The arm utilizes the GPS™ II Platelet Concentrate Separation Kit.
 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.
No Intervention: B
This arm utilizes standard leg wound closure procedures.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00514241

Locations
Norway
Feiringklinikken AS
Feiring, Norway
Sponsors and Collaborators
Biomet Norge A.S.
Investigators
Principal Investigator: Christian Fredrik Stray, B. Sc, MBA Biomet Norge A.S.
  More Information

No publications provided

Responsible Party: Biomet, Inc. ( Biomet Norge A.S. )
ClinicalTrials.gov Identifier: NCT00514241     History of Changes
Other Study ID Numbers: JA-250-N
Study First Received: August 8, 2007
Last Updated: December 5, 2011
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013