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. 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
Zimmer Biomet
Cabell Huntington Hospital
Information provided by:
Marshall University

Brief Summary:
The purpose of this study is to determine if the application of autologous (your own blood) blood products during mastectomy improves wound healing and decreases complications following surgery compared to mastectomy without the use of autologous blood products.

Condition or disease Intervention/treatment Phase
Mastectomy Procedure: Application of autologous blood products. Procedure: Standard Modified Radical Mastectomy Phase 3

Detailed Description:
A frequent complication of mastectomy is seroma formation with rates in the literature reported at 3-50%. Although seroma formation can be considered more of a nuisance than a serious complication, the presence of seroma can lead to wound infection, skin flap necrosis, wound dehiscence, nerve injury, and lymphedema in mastectomy patients.Various approaches to reduce seroma formation have included the use of external compression dressings, ultrasound cutting devices, suction drainage systems, and bovine thrombin. Although some of these interventions have demonstrated efficacy, none has gained widespread acceptance. Investigation of alternative interventions during mastectomy procedures that could reduce the rate of postoperative seroma formation, thereby reducing the likelihood of the onset of more serious complications, still has value to the patient and surgeon. The use of autologous blood products (ABP), in particular platelet rich plasma (PRP), has been advocated for numerous indications. As a surgical tool, ABP are typically applied to the surgical site during the latter stages of the procedure in combination with bovine thrombin. The aim of 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. Preliminary evidence suggests that this expedited healing response correlates with a reduction in postoperative wound complications. Platelet poor plasma, a by-product of PRP processing, has been advocated as providing additional hemostasis. The majority of the literature discussing clinical applications of ABP to date, has been unblinded and nonrandomized. Although useful as demonstrations of the safety of ABP, this current literature does not truly investigate the efficacy of these applications. There is a need for well-designed, well-controlled studies investigating the application of ABP as surgical tools. It is hypothesized that a significant reduction in postoperative complications, in particular seroma formation, will result due to the use of ABP during these procedures.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mastectomy
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
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.

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patient undergoing a modified radical mastectomy, simple mastectomy or axillary lymph node dissection.
  2. Patient signature of informed consent form

Exclusion Criteria:

  1. Pregnancy
  2. < 18 years of age
  3. History of anemia (hemoglobin < 11.0)
  4. History of any blood disorder, deep vein thrombosis, pulmonary emboli or clotting disorders.
  5. 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
  6. Allergy to bovine products
  7. History of MRSA in last 12 months
  8. Communicable disease or diseases that may limit follow- up (e.g. immunocompromised conditions, hepatitis, active tuberculosis)

Information from the National Library of Medicine

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 identifier (NCT number): NCT00802477

Contact: GiGi Gerlach, RN 304-399-3386
Contact: Leann R Ross, RN 304-399-6617

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   
Principal Investigator: Shawn McKinney, MD         
Sub-Investigator: Jack Traylor, MD         
Sponsors and Collaborators
Marshall University
Zimmer Biomet
Cabell Huntington Hospital
Principal Investigator: Shawn McKinney, MD University Physicians and Surgeons, Inc. d/b/a University Oncology Services

Responsible Party: Shawn McKinney, MD, Marshall University Joan C. Edwards School of Medicine Identifier: NCT00802477     History of Changes
Other Study ID Numbers: MU9339
First Posted: December 5, 2008    Key Record Dates
Last Update Posted: August 1, 2011
Last Verified: July 2011

Keywords provided by Marshall University:
lymph node dissection