Comparison of FlexHD and Alloderm Outcomes in Breast Reconstructive Surgery

University of Arkansas

Status and phase: Withdrawn; Phase 4

Conditions: Breast Neoplasm

Treatments: Biological: FlexHD; Biological: Alloderm

Study type: Interventional

Funder types: Other

Identifiers

NCT02372305

203456

Details and patient eligibility

About

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

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

FlexHD

Active Comparator group

Description:

Patients randomly assigned to receive FlexHD for breast reconstruction.

Treatment:

Biological: FlexHD

Alloderm

Active Comparator group

Description:

Patients randomly assigned to receive Alloderm for breast reconstruction.

Treatment:

Biological: Alloderm