Tissue Expander/Implant Reconstruction: A Single-Blinded, Randomized, Controlled Trial
Following mastectomy (removal of your breast), reconstruction of your breast(s) can be performed using tissue expanders and implants. At the same operation as your mastectomy, a tissue expander is put under the skin and muscles of your chest.
Following your surgery, the tissue expander is gradually filled with salt water over a period of months. Once the expander is filled to the size of your new breast, a second operation is performed. At this time, the tissue expander is removed and a permanent breast implant is placed. This is a standard procedure. We are interested in learning about the use of AlloDerm in breast reconstruction. AlloDerm can be used instead of some of your own chest muscles, in order to cover and protect a tissue expander. We want to know if the use of AlloDerm can decrease your pain or discomfort after surgery and after the filling of your tissue expander.
AlloDerm is made from human tissue. When AlloDerm is made all the cells that could cause your body to reject it are removed. When it is placed in your chest, your own cells will then grow into the AlloDerm, causing it to act like the muscle it is replacing. In this study, you will either have reconstruction with AlloDerm or without AlloDerm.
|Breast Cancer||Procedure: Alloderm, Questionnaires Procedure: Without ALLODERM, Questionnaires||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
|Official Title:||The Use of Alloderm in Two-Stage, Tissue Expander/Implant Reconstruction: A Single-Blinded, Randomized, Controlled Trial|
- whether using Alloderm to create the inferior-medial portion of the expander pocket will decrease patient-reported pain in both the immediate, post-operative period and during the expansion phase. [ Time Frame: conclusion of the study ]
- To examine if the use of Alloderm will decrease patient-reported sensory morbidity in both the immediate, post-operative period and during the expansion phase. [ Time Frame: conclusion of the study ]
- To evaluate whether the use of Alloderm in tissue expander/implant reconstruction affects the rate of postoperative expansion and in-hospital narcotic use. [ Time Frame: conclusion of the study ]
- To examine if the use of Alloderm will impact both chronic breast pain and sensory morbidity. [ Time Frame: conclusion of the study ]
- To evaluate patient satisfaction following postmastectomy, tissue expander-implant reconstruction with and without the use of Alloderm. [ Time Frame: conclusion of the study ]
- To examine the effect of Alloderm on the overall aesthetic outcome, including the formation of capsular contracture, following tissue expander/implant reconstruction. [ Time Frame: conclusion of the study ]
|Actual Study Start Date:||March 2008|
|Estimated Study Completion Date:||March 2018|
|Estimated Primary Completion Date:||March 2018 (Final data collection date for primary outcome measure)|
Expander Placement WITH Alloderm
Procedure: Alloderm, Questionnaires
All patients will undergo placement of a temporary tissue expander immediately following mastectomy.Patients will undergo the surgical creation of an expander pocket using implantable Alloderm.
Active Comparator: B
Expander Placement WITHOUT Alloderm
Procedure: Without ALLODERM, Questionnaires
A standard, sub-muscular pocket dissection will be performed in the patients assigned to the control group. No Alloderm will be used.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00639106
|United States, Michigan|
|University of Michigan Health System|
|Ann Arbor, Michigan, United States, 48109|
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|United States, North Carolina|
|University of North Carolina School of Medicine|
|Chapel Hill, North Carolina, United States, 27514|
|Principal Investigator:||Joseph Disa, MD||Memorial Sloan Kettering Cancer Center|