Randomized Feasibility Trial for Mesh in Pre-Pectoral Reconstruction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Acellular Dermal Matrix, Reconstruction without ADM.
- Who it may be relevant to
- Registry conditions: Breast Cancer, Breast Implant; Complications, Infection or Inflammation. Basic parameters: 22 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
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
Interventions
- Device Acellular Dermal Matrix
Acellular dermal matrix will surgically implanted around the tissue expanders in patients in the ADM cohort. - Procedure Reconstruction without ADM
Acellular dermal matrix will not be surgically implanted around the tissue expanders in patients in the control cohort.
Primary outcome measures
- Safety - Major Complications [Time frame: 2 years]
- Effectiveness - BREASTQ [Time frame: 2 years]
Secondary outcome measures (3)
- Secondary Effectiveness [Time frame: 2 years]
- Secondary Safety [Time frame: 2 years]
- Capsular Contracture [Time frame: 2 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of California Los Angeles — Los Angeles
Identifiers
NCT: NCT05190978 · 190311