Trial record 4 of 93 for:    Open Studies | mastectomy

Application Of Autologous Blood Products During Modified Radical Mastectomy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Marshall University.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Biomet, Inc.
Cabell Huntington Hospital
Information provided by:
Marshall University
ClinicalTrials.gov Identifier:
NCT00802477
First received: December 4, 2008
Last updated: July 29, 2011
Last verified: July 2011
  Purpose

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 Intervention Phase
Mastectomy
Procedure: Application of autologous blood products.
Procedure: Standard Modified Radical Mastectomy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Marshall University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: December 2008
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

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

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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00802477

Contacts
Contact: GiGi Gerlach, RN 304-399-3386 gigi.gerlach@chhi.org
Contact: Leann R Ross, RN 304-399-6617 leann.ross@chhi.org

Locations
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    leann.ross@chhi.org   
Principal Investigator: Shawn McKinney, MD         
Sub-Investigator: Jack Traylor, MD         
Sponsors and Collaborators
Marshall University
Biomet, Inc.
Cabell Huntington Hospital
Investigators
Principal Investigator: Shawn McKinney, MD University Physicians and Surgeons, Inc. d/b/a University Oncology Services
  More Information

No publications provided

Responsible Party: Shawn McKinney, MD, Marshall University Joan C. Edwards School of Medicine
ClinicalTrials.gov Identifier: NCT00802477     History of Changes
Other Study ID Numbers: MU9339
Study First Received: December 4, 2008
Last Updated: July 29, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Marshall University:
mastectomy
seroma
lymph node dissection

ClinicalTrials.gov processed this record on August 28, 2014