Randomized Feasibility Trial for Mesh in Pre-Pectoral Reconstruction

Study Overview
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Brief Summary
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Surgical mesh products, particularly acellular dermal matrices (ADM), are now used by the majority of plastic surgeons to assist with the nearly 100,000 prosthetic breast reconstruction procedures in the United States, despite never being approved by Food and Drug Administration (FDA) for this indication. As surgeons transition to placing breast implants above the chest muscle (pre-pectoral), there has been an increasing reliance on these often expensive mesh products without robust evidence to understand their risks and benefits. Our pilot study is a randomized multi-center trial to evaluate surgical mesh assistance in pre-pectoral tissue expander to breast implant reconstruction to address vital questions for women's public health.

Detailed Description
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One in eight women will develop breast cancer in her lifetime, causing both physical and psychological trauma due to invasive treatments and the distress associated with removal of a breast. Breast reconstruction after mastectomy has become a critical procedure for many women to restore psychological wellbeing, with implant-based reconstruction the most common approach. Nearly 100,000 patients undergo reconstruction with implants every year in the United States. Surgical mesh devices, particularly acellular dermal matrices, are now used off-label by most reconstructive surgeons performing prosthetic breast reconstruction. In the past decade, surgeons have advocated a transition from submuscular reconstruction (placement of the implant under the pectoralis muscle) to pre-pectoral (placement above the pectoralis) and often consider mesh to be necessary for this procedure. Surgical mesh has not been approved by the FDA for breast reconstruction for either anatomic location. These mesh devices are considered Class III medical devices and FDA recently prioritized the evaluation of these products during a panel meeting in 2019. No Level I randomized trial has been successfully performed to determine the actual risks and benefits of mesh devices in breast reconstruction. This study proposes a pilot study as the first ever randomized, multi-center trial for mesh assistance in two-stage prosthetic pre-pectoral breast reconstruction, across the major manufacturers. The goals are to demonstrate feasibility of such a study and to generate high level data toward the evaluation of safety and effectiveness of these products for the benefit of women's public health

Official Title
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Randomized Feasibility Trial for Mesh in Pre-Pectoral Reconstruction

Conditions
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Breast Cancer, Breast Implant; Complications, Infection or Inflammation

Intervention / Treatment
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* Device: Acellular Dermal Matrix
* Procedure: Reconstruction without ADM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female patients age 22 to 75 undergoing unilateral or bilateral immediate pre-pectoral reconstruction with tissue expanders Prophylactic and oncologic mastectomies are both acceptable Nipple sparing and skin sparing mastectomy techniques are both acceptable Exclusion Criteria: Intraoperative assessment demonstrates unfavorable conditions (ie poor mastectomy skin flap thickness or viability) for immediate pre-pectoral reconstruction in any breast Bilateral reconstruction patients undergoing contralateral submuscular reconstruction Direct-to-implant reconstruction Pregnancy Delayed reconstruction

Ages Eligible for Study
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Minimum Age: 22 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
Interventional Model Description: Randomized Controlled Trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acellular Dermal Matrix<br>Patients will receive ADM during their initial tissue expander placement. | Device: Acellular Dermal Matrix<br>* Acellular dermal matrix will surgically implanted around the tissue expanders in patients in the ADM cohort.<br>|
| Active Comparator: Control<br>Patients will not receive ADM during their initial tissue expander placement. | Procedure: Reconstruction without ADM<br>* Acellular dermal matrix will not be surgically implanted around the tissue expanders in patients in the control cohort.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety - Major Complications | Relative rate of major complications (requiring unplanned re-admission or re-operation) | 2 years | 
| Effectiveness - BREASTQ | BREAST-Q validated patient reported questionnaire to assess results of final reconstruction. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Effectiveness | Time from expander placement to implant exchange | 2 years | 
| Secondary Safety | Individual complication rates | 2 years | 
| Capsular Contracture | Rate of capsular contracture | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, breast reconstruction, breast implant