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Application Of Autologous Blood Products During Modified Radical Mastectomy

NCT00802477 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2011-08-01

No results posted yet for this study

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

Interventions

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.

PROCEDURE

Standard Modified Radical Mastectomy

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

Sponsors & Collaborators

  • Zimmer Biomet

    collaborator INDUSTRY

  • Cabell Huntington Hospital

    collaborator OTHER

  • Marshall University

    lead OTHER

Principal Investigators

  • Shawn McKinney, MD · University Physicians and Surgeons, Inc. d/b/a University Oncology Services

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2012-01-31
Completion
2012-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00802477 on ClinicalTrials.gov