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A Study Assessing the Use of AlloDerm in Two-Stage, Tissue Expander/Implant Breast Reconstruction
[Protocol 08-024]
- Full Title :
- THE USE OF ALLODERM IN TWO-STAGE, TISSUE EXPANDER/IMPLANT RECONSTRUCTION: A SINGLE-BLINDED, RANDOMIZED, CONTROLLED TRIAL
- Purpose :
Following mastectomy (removal of the breast as a treatment for cancer), breast reconstruction can be performed using tissue expanders and implants. During the same operation as the mastectomy, a tissue expander is put under the skin and muscles of the chest. Following surgery, the tissue expander is gradually filled with salt water over a period of several months. Once the expander is filled to the size of the new breast, a second operation is performed, when the tissue expander is removed and a permanent
breast implant is put in place. This is a standard procedure.
Researchers at Memorial Sloan-Kettering Cancer Center are interested in learning about the use of AlloDerm in breast reconstruction. AlloDerm can be used instead of some of the patient's own chest muscles, in order to cover and protect a tissue expander. Doctors want to know if the use of AlloDerm can decrease pain or discomfort after surgery and after the filling of the tissue expander.
AlloDerm is made from human tissue. All the cells that could cause a patient's body to reject it are removed. When it is placed in the chest, the patient's own cells then grow into the AlloDerm, causing it to act like the muscle it is replacing. In this study, patients will have reconstruction with or without AlloDerm, and the two groups will be compared. Patients will complete questionnaires about pain and sensory symptoms.
- Eligibility :
Participants eligible for this study include women age 21 to 75 who are undergoing tissue expander/implant reconstruction immediately after mastectomy at Memorial Sloan-Kettering Cancer Center.
For more information, please contact Dr. Joseph Disa at 212-639-5022.
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