Comparison of FlexHD and Alloderm Outcomes in Breast Reconstructive Surgery
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|ClinicalTrials.gov Identifier: NCT02372305|
Recruitment Status : Withdrawn (PI is no longer at institution. IRB closed study due to lack of response from PI)
First Posted : February 26, 2015
Last Update Posted : July 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Breast Neoplasm||Biological: FlexHD Biological: Alloderm||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of FlexHD and Alloderm Outcomes in Breast Reconstructive Surgery|
|Study Start Date :||March 2016|
|Actual Primary Completion Date :||December 21, 2017|
|Actual Study Completion Date :||December 21, 2017|
Active Comparator: FlexHD
Patients randomly assigned to receive FlexHD for breast reconstruction.
Patients will be randomized to receive FlexHD.
Active Comparator: Alloderm
Patients randomly assigned to receive Alloderm for breast reconstruction.
Patient will be randomized to receive Alloderm.
- Wound Dehiscence [ Time Frame: One Year ]time frame.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02372305
|United States, Arkansas|
|University of Arkansas for Medical Sciences|
|Little Rock, Arkansas, United States, 72205|
|Principal Investigator:||Pallavi A Kumbla, MD||UAMS|