Comparing Two Different Surgical Techniques for Breast Reconstruction

Study Overview
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Brief Summary
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The purpose of this study is to compare two standard techniques for breast reconstruction-the prepectoral technique and the subpectoral technique. Again, the prepectoral technique involves putting a tissue expander on top of the pectoralis muscle, while the subpectoral technique involves putting a tissue expander under the pectoralis muscle. The standard approach used at MSK is the subpectoral technique. This study will help researchers find out whether the subpectoral approach is better, the same as, or worse than the prepectoral approach. To decide which approach is better, the researchers will look at which technique causes fewer complications after surgery (for example, infection or the need for a second surgery). Researchers are also interested in seeing which approach causes less pain and use of pain medication after surgery.

Official Title
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A Randomized Controlled Trial of Prepectoral Versus Subpectoral Prosthetic Breast Reconstruction

Conditions
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Breast Reconstruction

Intervention / Treatment
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* Procedure: Prepectoral Prosthetic Breast Reconstruction
* Procedure: Subpectoral Prosthetic Breast Reconstruction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women aged 21-60 years Planning to undergo immediate two stage prosthetic breast reconstruction with TE placement as the first stage. Planning to undergo unilateral or bilateral mastectomy. Planning to undergo nipple- or skin-sparing mastectomy. Mastectomy weight less than 800 grams. Adequate mastectomy skin perfusion or patients with adequate perfusion but nonviable mastectomy skin that can be excised (≤ 4 cm) at the defect margins with otherwise adequate perfusion. Exclusion Criteria: Receipt of neoadjuvant chemotherapy for locally advanced breast cancer. Presence of preoperative axillary lymph node metastasis. Presence of intraoperative sentinel node positivity. History of radiotherapy. Current smoker. Planning to undergo direct-to-implant reconstruction. BMI >35. Prior sternotomy.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 60 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prepectoral Prosthetic Breast Reconstruction<br> | Procedure: Prepectoral Prosthetic Breast Reconstruction<br>* The prepectoral approach involves placing the tissue expander on top of the pectoralis muscle.<br>|
| Active Comparator: Subpectoral Prosthetic Breast Reconstruction<br> | Procedure: Subpectoral Prosthetic Breast Reconstruction<br>* The subpectoral approach involves placing the tissue expander under the pectoralis muscle with or without acellular dermal matrix (ADM).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| major perioperative complications | 90-day major complications for tissue expanders (i.e., infection, explantation, and reoperation for mastectomy flap necrosis): Infection: any event requiring restart of antibiotics (oral or intravenous) following completion of initial perioperative antibiotics or an admission to the hospital for cellulitis. Explantation: need for tissue expander removal for any cause. Reoperation: skin excision performed in either the clinic or the main operating room for mastectomy skin flap necrosis. | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| minor complications | Minor complication for tissue expanders is defined as: Seroma: clinically significant non-infected fluid collection requiring either needle aspiration or drain replacement | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prosthetic, Breast tissue expander, 20-565