Comparison of FlexHD and Alloderm Outcomes in Breast Reconstructive Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-12-21

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.

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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

Conditions

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Breast Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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FlexHD

Patients randomly assigned to receive FlexHD for breast reconstruction.

Group Type ACTIVE_COMPARATOR

FlexHD

Intervention Type BIOLOGICAL

Patients will be randomized to receive FlexHD.

Alloderm

Patients randomly assigned to receive Alloderm for breast reconstruction.

Group Type ACTIVE_COMPARATOR

Alloderm

Intervention Type BIOLOGICAL

Patient will be randomized to receive Alloderm.

Interventions

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FlexHD

Patients will be randomized to receive FlexHD.

Intervention Type BIOLOGICAL

Alloderm

Patient will be randomized to receive Alloderm.

Intervention Type BIOLOGICAL

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes