Status:
UNKNOWN
Application Of Autologous Blood Products During Modified Radical Mastectomy
Lead Sponsor:
Marshall University
Collaborating Sponsors:
Zimmer Biomet
Cabell Huntington Hospital
Conditions:
Mastectomy
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 compar...
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, th...
Eligibility Criteria
Inclusion
- Patient undergoing a modified radical mastectomy, simple mastectomy or axillary lymph node dissection.
- Patient signature of informed consent form
Exclusion
- 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)
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2012
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00802477
Start Date
December 1 2008
End Date
March 1 2012
Last Update
August 1 2011
Active Locations (1)
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1
University Oncology Services at Edwards Comprehensive Cancer Center
Huntington, West Virginia, United States, 25701