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

This study has been completed.

First Received on April 21, 2008. Last Updated on December 5, 2011 History of Changes

Sponsor:	Biomet Biologics, LLC
Collaborator:	University of Western Ontario, Canada
Information provided by (Responsible Party):	Biomet, Inc. ( Biomet Biologics, LLC )
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

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

U.S. FDA Resources

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 ]

Enrollment:	204
Study Start Date:	January 2008
Study Completion Date:	November 2010
Primary Completion Date:	May 2010 (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.
Active Comparator: 2 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

Locations

Canada, Ontario
University of Western Ontario: Division of Thoracic Surgery
London, Ontario, Canada, N6A 5W9

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:	Biomet, Inc. ( Biomet Biologics, LLC )
ClinicalTrials.gov Identifier:	NCT00665912 History of Changes
Other Study ID Numbers:	BBI-004
Study First Received:	April 21, 2008
Last Updated:	December 5, 2011
Health Authority:	Canada: Ethics Review Committee

Additional relevant MeSH terms:

Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site

Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on February 09, 2012