Application Of Autologous Blood Products During Modified Radical Mastectomy

NCT00802477 | Unknown Phase 3 DMC

• 1 other identifier: MU9339
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Mastectomy

Keywords

mastectomy; seroma; lymph node dissection

Outcome Measures

Primary Outcomes (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.

  7 days

Secondary Outcomes (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

  6 weeks post -op

Study Arms (2)

1

EXPERIMENTAL

Application of Autologous Blood Products to surgical site during mastectomy.

Procedure: Application of autologous blood products.

2

ACTIVE COMPARATOR

Standard Modified Radical Mastectomy

Procedure: Standard Modified Radical Mastectomy

Interventions

Application of autologous blood products. PROCEDURE

Autologous blood products (platelet rich and platelet poor plasma) produced by the PlasmaxTM Plus Plasma Concentration System will be applied to the surgical site.

1

Standard Modified Radical Mastectomy PROCEDURE

Mastectomy per standard procedure without the application of autologous blood products.

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Marshall University: lead
• Zimmer Biomet: collaborator
• Cabell Huntington Hospital: collaborator

Study Sites (1)

University Oncology Services at Edwards Comprehensive Cancer Center

Huntington, West Virginia, 25701, United States

RECRUITING

MeSH Terms

Conditions

Seroma

Condition Hierarchy (Ancestors)

Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Shawn McKinney, MD

  University Physicians and Surgeons, Inc. d/b/a University Oncology Services

  PRINCIPAL INVESTIGATOR

Central Study Contacts

GiGi Gerlach, RN

CONTACT

304-399-3386; gigi.gerlach@chhi.org

Leann R Ross, RN

CONTACT

304-399-6617; leann.ross@chhi.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 4, 2008
• First Posted: December 5, 2008
• Study Start: December 1, 2008
• Primary Completion: January 1, 2012
• Study Completion: March 1, 2012
• Last Updated: August 1, 2011

Record last verified: 2011-07

Locations

US (1)