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.
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.
- Women who are eligible for immediate, implant-based reconstruction following skin- sparing or nipple-sparing mastectomy
- 18 years of age or older
- Understand English
- 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.
- Women will have an equal chance (similar to tossing a coin) of being selected for the one-stage or two-stage breast reconstruction procedure.
- 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.
- 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
- 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.
- Questionnaires that measure:
- Satisfaction with breast appearance
- Body image & quality of life
- 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.