Compare Outcomes Between Two Acellular Dermal Matrices

Summary

This study will evaluate the performance of Alloderm RTU medium (LifeCell) vs. Cortiva 1mm Allograft Dermis (RTI Surgical®, Inc.). These are the thinnest versions of acellular dermal matrices (ADM) offered by both vendors and can be used for post-mastectomy breast reconstruction. Alloderm RTU medium has a thickness of 1.6±0.4 mm, while Cortiva 1mm Allograft Dermis has a thickness of 1.0±0.2 mm. In the context of breast reconstruction, these ADMs are used in the same manner. They may be inserted with a tissue expander immediately after skin- or nipple-sparing mastectomy. The investigators will examine breast-reconstruction associated complication rates, pre- and post-operative patient reported outcomes using the Breast Q, and physician reimbursement as well as direct hospital costs. The endpoint will be either exchange of the tissue expander for a permanent breast implant or autologous flap, explantation due to patient preference, development of a complication, or less common reasons. The investigators propose that Cortiva 1mm Allograft Dermis and Alloderm RTU will have equivalent complication and patient reported outcome rates as well as physician reimbursement, but that direct hospital cost will be less with Cortiva 1mm Allograft Dermis.

Conditions

• Breast Cancer

Interventions

OTHER

Alloderm RTU

-Most commonly used acellular dermal matrices

OTHER

Cortiva 1mm Allograft Dermis

-Tutoplast processed dermis

PROCEDURE

Skin or nipple-sparing mastectomy

-Standard of care

OTHER

Breast Q

* 15 questions * 10 questions in Part A asking how has the patient been feeling in past 24 hours, answers range from 0-10 with 0=none of the time and 10=all of the time * Part B has 5 questions asking patient if she has had any of the following in the last 24 hours, answers ranging from 0-10 with 0=none of the time and 10=all of the time

PROCEDURE

Surgery

* To address the tissue expander * Standard of care

Sponsors & Collaborators

• RTI Surgical

  collaborator INDUSTRY

• Washington University School of Medicine

  lead OTHER

Principal Investigators

• Terence M Myckatyn, M.D. · Washington University School of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

22 Years

Max Age

70 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-01-31

Primary Completion

2022-10-27

Completion

2022-10-27

Countries

• United States

Study Locations