Application Of Autologous Blood Products During Modified Radical Mastectomy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00802477|
Recruitment Status : Unknown
Verified July 2011 by Marshall University.
Recruitment status was: Recruiting
First Posted : December 5, 2008
Last Update Posted : August 1, 2011
|Condition or disease||Intervention/treatment||Phase|
|Mastectomy||Procedure: Application of autologous blood products. Procedure: Standard Modified Radical Mastectomy||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Prospective Randomized Study Comparing Mastectomy Outcomes With Versus Without the Application of Autologous Blood Products to the Surgical Site|
|Study Start Date :||December 2008|
|Estimated Primary Completion Date :||January 2012|
|Estimated Study Completion Date :||March 2012|
Application of Autologous Blood Products to surgical site during mastectomy.
Procedure: Application of autologous blood products.
Autologous blood products (platelet rich and platelet poor plasma) produced by the PlasmaxTM Plus Plasma Concentration System will be applied to the surgical site.
Active Comparator: 2
Standard Modified Radical Mastectomy
Procedure: Standard Modified Radical Mastectomy
Mastectomy per standard procedure without the application of autologous blood products.
- Amount of Drainage during first 7 days postoperative. Drains will be removed during a follow-up visit to be held seven days postoperatively or when drainage is 30-35 ml in a 24 hour period, unless prohibited by complication. [ Time Frame: 7 days ]
- The secondary endpoint for this study will be the rate of patients experiencing at least one of the following postoperative wound complications: 1. Seroma Formation 2. Surgical Site Infection [ Time Frame: 6 weeks post -op ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00802477
|Contact: GiGi Gerlach, RNfirstname.lastname@example.org|
|Contact: Leann R Ross, RNemail@example.com|
|United States, West Virginia|
|University Oncology Services at Edwards Comprehensive Cancer Center||Recruiting|
|Huntington, West Virginia, United States, 25701|
|Contact: Leann Ross, RN 304-399-6617 firstname.lastname@example.org|
|Principal Investigator: Shawn McKinney, MD|
|Sub-Investigator: Jack Traylor, MD|
|Principal Investigator:||Shawn McKinney, MD||University Physicians and Surgeons, Inc. d/b/a University Oncology Services|