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

Study Overview
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Brief Summary
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: Alloderm, Questionnaires
* Procedure: Without ALLODERM, Questionnaires


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who undergo immediate, postmastectomy, tissue expander/implant reconstruction Patients ≥ 21 and ≤ 75 years of age Exclusion Criteria: Patient refusal Patients who will undergo any of the following: Single-stage implant reconstruction Combined autogenous tissue expander/implant reconstruction Patients with a history of prior irradiation Patients with a history of prior surgery with breast implants Patients with a history of prior axillary lymph node dissection Patients who are pregnant The following eligibility will be confirmed at the time of surgery. Patients who are deemed intraoperatively by the attending surgeon to have significant mastectomy flap ischemia. Patients who have an axillary lymph node dissection at the time of mastectomy (Patients undergoing sentinel lymph biopsy are eligible)

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Expander Placement WITH Alloderm | Procedure: Alloderm, Questionnaires<br>* 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.<br>* Other names: and at 6 and 12 months following the exchange procedure will take approximately 45 minutes;|
| Active Comparator: B<br>Expander Placement WITHOUT Alloderm | Procedure: Without ALLODERM, Questionnaires<br>* A standard, sub-muscular pocket dissection will be performed in the patients assigned to the control group. No Alloderm will be used.<br>* Other names: and at 6 and 12 months following the exchange procedure will take approximately 45 minutes;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | conclusion of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 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. |  | conclusion of the study | 
| To examine if the use of Alloderm will impact both chronic breast pain and sensory morbidity. |  | conclusion of the study | 
| To evaluate patient satisfaction following postmastectomy, tissue expander-implant reconstruction with and without the use of Alloderm. |  | 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. |  | conclusion of the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast expander, Breast reconstruction, implants, 08-024