Comparison of FlexHD and Alloderm Outcomes in Breast Reconstructive Surgery
| Status: | Withdrawn |
|---|---|
| Conditions: | Breast Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/20/2018 |
| Start Date: | March 2016 |
| End Date: | December 21, 2017 |
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.
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.
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
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
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
We found this trial at
1
site
529 West Markham Street
Little Rock, Arkansas 72205
Little Rock, Arkansas 72205
(501) 686-7000
University of Arkansas for Medical Sciences The University of Arkansas for Medical Sciences (UAMS) in...
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