Comparison of FlexHD and Alloderm Outcomes in Breast Reconstructive Surgery

Study Overview
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Brief Summary
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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
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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

Official Title
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Comparison of FlexHD and Alloderm Outcomes in Breast Reconstructive Surgery

Conditions
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Breast Neoplasm

Intervention / Treatment
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* Biological: FlexHD
* Biological: Alloderm


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: FlexHD<br>Patients randomly assigned to receive FlexHD for breast reconstruction. | Biological: FlexHD<br>* Patients will be randomized to receive FlexHD.<br>|
| Active Comparator: Alloderm<br>Patients randomly assigned to receive Alloderm for breast reconstruction. | Biological: Alloderm<br>* Patient will be randomized to receive Alloderm.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound Dehiscence | time frame. | One Year |