Platelet-Rich and Concentrated Platelet-Poor Plasma to Reduce Air Leak Post-Lobectomy: A Randomized Controlled Trial

This study is currently recruiting participants.

Verified by Biomet, Inc., January 2009

First Received: April 21, 2008 Last Updated: January 8, 2009 History of Changes

Sponsors and Collaborators:	Biomet Biologics, LLC University of Western Ontario, Canada
Information provided by:	Biomet, Inc.
ClinicalTrials.gov Identifier:	NCT00665912

Purpose

The purpose of this study is to determine whether the use of platelet-rich plasma (PRP) and concentrated platelet-poor plasma (PPPc) can reduce the duration of post-operative air leak after lobectomy for lung tumours.

Condition	Intervention
Lung Cancer	Procedure: Standard post-lobectomy wound care plus use of PRP and PPPc prepared by GPS and Plasmax respectively Procedure: Standard post-lobectomy wound care

MedlinePlus related topics: Cancer Lung Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Caregiver, Investigator), Parallel Assignment
Official Title:	Platelet-Rich and Concentrated Platelet Poor Plasma to Reduce Air Leak Post Lobectomy: A Randomized Controlled Trial

Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:

Duration of postoperative air leak [ Time Frame: Every 4 hours of postop hospital stay, between 4-6 weeks postop ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Incidence of air leak, Prolonged air leak (> days), Complications [ Time Frame: Every 4 hours of postop hospital stay, between 4-6 weeks postop ] [ Designated as safety issue: No ]

Estimated Enrollment:	204
Study Start Date:	January 2008
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Standard post-lobectomy wound care plus use of PRP and PPPc in the thoracic cavity.	Procedure: Standard post-lobectomy wound care plus use of PRP and PPPc prepared by GPS and Plasmax respectively GPS is used to create the platelet rich plasma (PRP). Plasmax is used to create the concentrated platelet-poor plasma (PPPc). Both PRP and PPPc will be used for wound care in the thoracic cavity post-lobectomy.
2: Active Comparator Standard post-lobectomy wound care in the thoracic cavity	Procedure: Standard post-lobectomy wound care Standard post-lobectomy wound care

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients requiring a lobectomy

Exclusion Criteria:

Pneumonectomy
Sleeve lobectomy
Determination of unresectability (prior to the initiation of lobectomy)
Wedge resection alone

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00665912

Contacts

Contact: Dr. Richard Inculet, MD, FRCSC, FACS

519-667-6679

R.Inculet@lhsc.on.ca

Locations

Canada, Ontario
University of Western Ontario: Division of Thoracic Surgery	Recruiting
London, Ontario, Canada, N6A 5W9
Contact: Dr. Richard Inculet, MD, FRCSC, FACS 519-667-6679

Sponsors and Collaborators

Biomet Biologics, LLC

University of Western Ontario, Canada

Investigators

Principal Investigator:	Richard Inculet, MD, FRCSC, FACS	University of Western Ontario, Canada
Study Chair:	Darrin Payne, MD	University of Western Ontario, Canada
Study Chair:	Dalilah Fortin, MD	University of Western Ontario, Canada
Study Chair:	Richard Malthaner, MD	University of Western Ontario, Canada
Study Chair:	Robert Humphrey, MD	University of Western Ontario, Canada

More Information

No publications provided

Responsible Party:	University of Western Ontario ( Dr. Richard Inculet, MD, FACS, FRCSC )
Study ID Numbers:	BBI-004
Study First Received:	April 21, 2008
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00665912 History of Changes
Health Authority:	Canada: Ethics Review Committee

Study placed in the following topic categories:

Thoracic Neoplasms
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site

Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases

ClinicalTrials.gov processed this record on May 07, 2009