Clinical trial NCT05190978: Randomized Feasibility Trial for Mesh in Pre-Pectoral Reconstruction
Official title: Randomized Feasibility Trial for Mesh in Pre-Pectoral Reconstruction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Breast Implant; Complications, Infection or Inflammation
Keywords: breast cancer
breast reconstruction
breast implant
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
name: Weill Medical College of Cornell University
name: Yale University
name: University of California, Davis
name: University of Utah
name: University of California, San Francisco
First posted: 2022-01-13
Enrollment: 120
Sex: FEMALE
Minimum age (years): 22
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

Brief summary: 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

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

Primary outcomes:
measure: Safety - Major Complications
timeFrame: 2 years
measure: Effectiveness - BREASTQ
timeFrame: 2 years
Secondary outcomes:
measure: Secondary Effectiveness
timeFrame: 2 years
measure: Secondary Safety
timeFrame: 2 years
measure: Capsular Contracture
timeFrame: 2 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Michael Delong, MD
role: PRINCIPAL_INVESTIGATOR
References: