Comparison of FlexHD and Alloderm Outcomes in Breast Reconstructive Surgery

Phase 4

Withdrawn

• Conditions: Breast Neoplasm
• Interventions: Biological: Alloderm; Biological: FlexHD

• Registration Number: NCT02372305
• Lead Sponsor: University of Arkansas

Brief 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

Study Timeline

• Study First Submitted: 2015-02-20
• Study First Submitted QC: 2015-02-25
• Study First Posted: 2015-02-26
• Study Start: 2016-03
• Primary Completion: 2017-12-21
• Study Completion: 2017-12-21
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-16
• Last Update Posted: 2018-07-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Alloderm	Alloderm	Patients randomly assigned to receive Alloderm for breast reconstruction.
FlexHD	FlexHD	Patients randomly assigned to receive FlexHD for breast reconstruction.

Primary Outcome Measures

Name	Time	Method
Wound Dehiscence	One Year	time frame.

Trial Locations

Locations (1)

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States