Expired Study
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Little Rock, Arkansas 72205


Purpose:

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.


Study 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


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


NCT ID:

NCT02372305


Primary Contact:

Principal Investigator
Pallavi A Kumbla, MD
UAMS


Backup Contact:

N/A


Location Contact:

Little Rock, Arkansas 72205
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 19, 2017

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