NCT02372305

Comparison of FlexHD and Alloderm Outcomes in Breast Reconstructive Surgery

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Arkansas · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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

Conditions

• Breast Neoplasm

Interventions

Type	Name	Description
BIOLOGICAL	FlexHD	Patients will be randomized to receive FlexHD.
BIOLOGICAL	Alloderm	Patient will be randomized to receive Alloderm.

Timeline

• Start date: 2016-03-01
• Primary completion: 2017-12-21
• Completion: 2017-12-21
• First posted: 2015-02-26
• Last updated: 2018-07-18

Locations

1 site across 1 country: United States