Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

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.

Alloderm, Questionnaires

A standard, sub-muscular pocket dissection will be performed in the patients assigned to the control group. No Alloderm will be used.

Without ALLODERM, Questionnaires

Joseph Disa, MD

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.

Tissue Expander/Implant Reconstruction: A Single-Blinded, Randomized, Controlled Trial

The Use of Alloderm in Two-Stage, Tissue Expander/Implant Reconstruction: A Single-Blinded, Randomized, Controlled Trial

University of Michigan

University of North Carolina, Chapel Hill

Memorial Sloan Kettering Cancer Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Tissue Expander/Implant Reconstruction: A Single-Blinded, Randomized, Controlled Trial	NCT00639106	Breast Cancer	Alloderm, Quest... Without ALLODER...	21 Years - 75 Years	Memorial Sloan Kettering Cancer Center
Tissue Expander/Implant Reconstruction: A Single-Blinded, Randomized, Controlled Trial	NCT00639106	Breast Cancer	Alloderm, Quest... Without ALLODER...	21 Years - 75 Years	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for without alloderm, questionnaires