Comparison of FlexHD and Alloderm Outcomes in Breast Reconstructive Surgery
Trial Snapshot
- Phase
- Phase 4
- Status
- Withdrawn
- Sponsor
- University of Arkansas
- Locations
- 1
- Primary Endpoint
- Wound Dehiscence
Study Overview
Brief 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.
Detailed 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Arms & Interventions
FlexHD
Patients randomly assigned to receive FlexHD for breast reconstruction.
Intervention: FlexHD (Biological)
Alloderm
Patients randomly assigned to receive Alloderm for breast reconstruction.
Intervention: Alloderm (Biological)
Outcomes
Primary Outcomes
Wound Dehiscence
Time Frame: One Year
time frame.
Secondary Outcomes
No secondary outcomes reported