Background:
While two stage tissue expander - implant breast reconstruction
is the most common way of reconstructing a breast after mastectomy
in North America, there have been recent reports of excellent implant
reconstruction results achieved with only one surgery using AlloDerm®.
No
studies, however, have compared the two methods head to head from a
long-term patient satisfaction point of view.
Dr. Toni Zhong, Co-Investigators: Dr. Stefan Hofer, Study Funding: Plastic Surgery Educational Foundation Study Contacts: If you have any questions, or would like to receive more information from the study team please call: |
|---|
This study was funded and supported by PSEF
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 has been no reports of infection or disease transmitted by 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 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:
Study Population :
• Women who are eligible for immediate, implant-based reconstruction following skin-
sparing or nipple-sparing mastectomy
• 18 years of age or older
• Understand English
Study Procedures:
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.
