Recruiting
Phase 3

Autologous Blood Products

Sponsor:

Marshall University

Code:

NCT00802477

Conditions

Mastectomy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Application of autologous blood products.

Standard Modified Radical Mastectomy

Study Details

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

Study ID

NCT00802477

Start date

Dec, 2008

Status verified date

Jul, 2011

Completion date

Mar, 2012

Anticipated

Primary completion date

Jan, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: 1

Application of Autologous Blood Products to surgical site during mastectomy.

active comparator: 2

Standard Modified Radical Mastectomy

Interventions

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.

Standard Modified Radical Mastectomy

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

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Locations

University Oncology Services at Edwards Comprehensive Cancer Center

Recruiting

Huntington, West Virginia, United States, 25701

Contacts

Principal Investigator:

Shawn McKinney, MD

More Information

Sponsor

Marshall University

Last update posted

Aug 1, 2011

Last verified

Jul, 2011

Keywords

  • mastectomy
  • seroma
  • lymph node dissection

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Marshall University on 2011-08-01.