Evaluate Use of Gravitational Platelet Separation System on Leg Wound Healing in Coronary Bypass Surgery - Full Text View

Sponsor:	Biomet Norge A.S.
Information provided by:	Biomet, Inc.
ClinicalTrials.gov Identifier:	NCT00514241

Purpose

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.

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

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

MedlinePlus related topics: Coronary Artery Bypass Surgery Heart Failure Surgery

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 ]

Estimated Enrollment:	140
Study Start Date:	January 2008
Estimated Study Completion Date:	January 2011
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental 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.
B: No Intervention This arm utilizes standard leg wound closure procedures.

Arms

Assigned Interventions

A: Experimental

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.

B: No Intervention

This arm utilizes standard leg wound closure procedures.

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 Norge A.S. ( Christian Fredrick Stray )
Study ID Numbers:	JA-250-N
Study First Received:	August 8, 2007
Last Updated:	January 9, 2009
ClinicalTrials.gov Identifier:	NCT00514241 History of Changes
Health Authority:	Norway: The National Committees for Research Ethics in Norway

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 08, 2010