One-stage Breast Reconstruction Using Dermal Matrix/Implant Versus Two-stage Expander/Implant Procedure

Summary

Currently the two-stage tissue expander/implant (TE/I) technique is the standard breast reconstructive option for breast cancer patients selected for immediate, skin-sparing mastectomy. This procedure has been demonstrated to be oncologically safe in patients with specific criteria for early stage breast cancer. The primary drawback, however, is that it requires two separate procedures under general anesthesia and multiple office visits for expander inflation to create the breast mound. Acellular dermal matrix has gained widespread acceptance for use in breast reconstruction and other areas and has the potential to provide support to the breast implant without tissue expansion in a one-stage procedure. The purpose of the study is to test this new procedure and to evaluate the impact of one-stage breast reconstruction using acellular dermis compared to the standard two-stage expander/implant technique on measures of patient satisfaction and quality of life.

Conditions

• Breast Cancer

Interventions

PROCEDURE

One-stage dermal matrix/implant procedure

One-stage breast reconstruction with dermal matrix and implant

PROCEDURE

Two-stage tissue expander/implant procedure

Two-stage breast reconstruction with tissue expander and implant

Sponsors & Collaborators

• Women's College Hospital

  collaborator OTHER

• Vancouver General Hospital

  collaborator OTHER

• Canadian Breast Cancer Foundation

  collaborator OTHER

• Tom Baker Cancer Centre

  collaborator OTHER

• University Health Network, Toronto

  lead OTHER

Principal Investigators

• Toni Zhong, MD FRCS(C) · University Health Network, Toronto

• Mitchell Brown, MD FRCS(C) · Women's College Hospital

• Stefan Hofer, MD FRCS(C) · University Health Network, Toronto

• John Semple, MD FRCS(C) · Women's College Hospital

• Brett Beber, MD FRCS(C) · Women's College Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2009-09-01

Primary Completion

2017-12-31

Completion

2017-12-31

Countries

• Canada

Study Locations