A Phase 3 interventional study of Alloderm, Questionnaires and Without ALLODERM, Questionnaires in Breast Cancer, sponsored by Memorial Sloan Kettering Cancer Center. Completed at 3 sites in United States. Open to female participants aged 21 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-10-03.
Sponsored by Memorial Sloan Kettering Cancer Center · Phase 3, Interventional, and Treatment
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.
Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,930 studies on the registry; 325 are open to participants now.
Of its 129 completed or terminated interventional studies of FDA-regulated products, 66 (51%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The following eligibility will be confirmed at the time of surgery.
Expander Placement WITH Alloderm
Procedure: Alloderm, Questionnaires
Expander Placement WITHOUT Alloderm
Procedure: Without 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.
Also known as: Questionnaires administered prior to mastectomy, on Post-op Day #1, prior to the first, second, and third injection and following completion of expansion will take approximately 20 minutes, to complete., It is expected that the panel of questionnaires administered at baseline (prior to mastectomy), and at 6 and 12 months following the exchange procedure will take approximately 45 minutes
A standard, sub-muscular pocket dissection will be performed in the patients assigned to the control group. No Alloderm will be used.
Also known as: Questionnaires administered prior to mastectomy, on Post-op Day #1, prior to the first, second, and third injection and following completion of expansion will take approximately 20 minutes, to complete., It is expected that the panel of questionnaires administered at baseline (prior to mastectomy), and at 6 and 12 months following the exchange procedure will take approximately 45 minutes
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
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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Memorial Sloan Kettering Cancer Center