NCT02372305 - Comparison of FlexHD and Alloderm Outcomes in Breast Reconstructive Surgery | Crick

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Breast Neoplasm

Interventions

FlexHDBIOLOGICAL

Patients will be randomized to receive FlexHD.

AllodermBIOLOGICAL

Patient will be randomized to receive Alloderm.

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Outcomes

Primary Outcomes

Wound Dehiscence

time frame.

Time frame: One Year