Application Of Autologous Blood Products During Modified Radical Mastectomy

Prospective Randomized Study Comparing Mastectomy Outcomes With Versus Without the Application of Autologous Blood Products to the Surgical Site

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.

Study Overview

• Status: Unknown
• Conditions: Mastectomy
• Intervention / Treatment: Procedure: Application of autologous blood products.; Procedure: Standard Modified Radical Mastectomy

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
• Enrollment (Anticipated): 100
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: GiGi Gerlach, RN; Phone Number: 304-399-3386; Email: gigi.gerlach@chhi.org
• Study Contact Backup: Name: Leann R Ross, RN; Phone Number: 304-399-6617; Email: leann.ross@chhi.org

Study Locations

• United States
  • West Virginia
    • Huntington, West Virginia, United States, 25701
      • Recruiting
      • University Oncology Services at Edwards Comprehensive Cancer Center
      • Contact: Leann Ross, RN; Phone Number: 304-399-6617; Email: leann.ross@chhi.org
      • Principal Investigator: Shawn McKinney, MD
      • Sub-Investigator: Jack Traylor, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	7 days

Secondary Outcome Measures

Outcome Measure	Time Frame
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	6 weeks post -op

Collaborators and Investigators

• Sponsor: Marshall University
• Collaborators: Zimmer Biomet; Cabell Huntington Hospital
• Investigators: Principal Investigator: Shawn McKinney, MD, University Physicians and Surgeons, Inc. d/b/a University Oncology Services

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Anticipated): January 1, 2012
• Study Completion (Anticipated): March 1, 2012

Study Registration Dates

• First Submitted: December 4, 2008
• First Submitted That Met QC Criteria: December 4, 2008
• First Posted (Estimate): December 5, 2008

Study Record Updates

• Last Update Posted (Estimate): August 1, 2011
• Last Update Submitted That Met QC Criteria: July 29, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: lymph node dissection; mastectomy; seroma
• Other Study ID Numbers: MU9339