Breast Cancer Clinical Trial
Comparison of FlexHD and Alloderm Outcomes in Breast Reconstructive Surgery
Summary
FlexHD and Alloderm are two common products used in breast reconstruction to hold tissue expanders and implants in place. There have been few chart review studies comparing outcomes between the two materials in breast reconstruction. These studies have determined there is no difference in complication rates between the two materials. However, there have never been any active studies to date. This study will serve as a randomized controlled trial comparing FlexHD and Alloderm. Several outcomes will be measured based off of inclusion and exclusion criteria to determine if either product is more suitable for use in breast reconstruction. This will be performed by randomly assigning patients to receive either FlexHD or Alloderm. Designated outcomes will be followed closely postoperatively. Outcomes will be statistically analyzed to determine complication rates between FlexHD and Alloderm and thus which product is better to use in breast reconstruction.
Full Description
FlexHD and Alloderm are two common products used in breast reconstruction to hold tissue expanders and implants in place. There have been few chart review studies comparing outcomes between the two materials in breast reconstruction. These studies have determined there is no difference in complication rates between the two materials. However, there have never been any active studies to date. This study will serve as a randomized controlled trial comparing FlexHD and Alloderm. Several outcomes will be measured based off of inclusion and exclusion criteria to determine if either product is more suitable for use in breast reconstruction. This will be performed by randomly assigning patients to receive either FlexHD or Alloderm. Designated outcomes will be followed closely postoperatively. Outcomes will be statistically analyzed to determine complication rates between FlexHD and Alloderm and thus which product is better to use in breast reconstruction
Eligibility Criteria
Inclusion Criteria:
BMI<30
No Prior Breast Radiation
No Prior Breast Reduction
No Diabetes Mellitus (IDDM and non-IDDM)
Non-smoker or quit >6 weeks prior
No breast implants or prior breast implants
No inflammatory or autoimmune disorders
No current anticoagulation therapy
No current pregnant
Exclusion Criteria:
BMI > 30
Prior Breast Radiation
Diabetes Mellitus - IDDM and non IDDM
Prior Breast Reduction
Active Smoker or Recently Quit <6 weeks
Prior Breast Implants
Inflammatory/Autoimmune Condition (ex. Lupus)
Current Anticoagulation Therapy
Pregnancy
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There is 1 Location for this study
Little Rock Arkansas, 72205, United States
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