Background:

The two stage tissue expander/ implant breast reconstruction is the most common way of building a breast after mastectomy in North America. Recently, there have been reports of excellent implant reconstruction results achieved with only one surgery using AlloDerm® and a permanent implant. No studies, however, have compared the two methods head to head from a long-term patient satisfaction, safety and aesthetics perspective.

Purpose:

To test the results of a one-stage implant reconstruction using AlloDerm® compared to the traditional two stage tissue expander/ implant procedure in women who are eligible for skin and/or nipple saving mastectomies.

What is AlloDerm®?

  • Made from the skin from a human body (donated cadaveric skin) that has been specially prepared for your body to accept it.
  • The use of AlloDerm® has been approved in Canada for many surgical procedures including breast reconstruction.
  • There have been no reports of infection, disease or rejection associated with using AlloDerm® during breast reconstruction.

Women will receive ONE of the following breast reconstruction procedures:

Two-stage Expander/ Implant (Traditional method)

  • First stage involves placing a tissue expander under the chest muscle. After weekly visits for expander inflation with saline solution the final implant will be put in 3-6 months later.

One-stage AlloDerm®/Implant (New method)

  • Single stage involves placing the dermal matrix material in with the chest muscle to provide a hammock-like support for the breast implant at the same time.

Eligibility:

  • Women who are eligible for immediate, implant-based reconstruction following skin- sparing or nipple-sparing mastectomy
  • 18 years of age or older
  • Understand English

Baseline Questionnaires:

  • Eligible women will complete an initial package of questionnaires for the study with questions about your breast-related quality of life, including feelings about the loss of your breast(s), body image and sexuality.
  • The questions will take 30 minutes of your time.

Randomization:

  • Women will have an equal chance (similar to tossing a coin) of being selected for the one-stage or two-stage breast reconstruction procedure.

Surgery:

  • The skin-saving mastectomy surgery will follow a standard procedure in both groups. Breast reconstruction will be either one- stage or two-stage right after the mastectomy surgery.

Follow-up:

  • Patients will attend the standard post- surgical visits depending on the type of breast reconstruction surgery.
  • Women assigned to the two-stage tissue expander/ implant procedure will attend weekly clinic visits to have the expanders filled to the right size before the implant is inserted.
  • An expert panel will review the aesthetic outcomes from standard before and after photos

Study Questionnaires:

  • Three more study follow-up questionnaires will be mailed to participants at 2 weeks, 6 and 12 months after their reconstruction surgery.
  • Each questionnaire will take less than 30 minutes to complete.
  • * No extra clinic visits required for the study and a small financial compensation will be provided.

Study Outcomes:

  1. Questionnaires that measure:
    • Satisfaction with breast appearance
    • Body image & quality of life
  2. Surgical complication rates

Potential Benefits and Risk of Being in the Trial:

Risks Related to Being in the Study

The risks of minor and major surgical complications we know of are the same for both the one-stage and two-stage breast reconstruction with implants. Benefits to Being in the Study

You may or may not/ receive any direct benefit from being in this study. However, information learned from this study can help other women receiving a mastectomy with breast reconstruction in the future.