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

This study has been completed.
Sponsor:
Collaborator:
University of Western Ontario, Canada
Information provided by (Responsible Party):
Biomet, Inc. ( Biomet Biologics, LLC )
ClinicalTrials.gov Identifier:
NCT00665912
First received: April 21, 2008
Last updated: December 5, 2011
Last verified: June 2011
History of Changes
  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 May 21, 2013