Randomized Feasibility Trial for Mesh in Pre-Pectoral Reconstruction

Breast Cancer Clinical Trial

Official title:

Randomized Feasibility Trial for Mesh in Pre-Pectoral Reconstruction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05190978
• Other study ID #: 190311
• Status: Recruiting
• Phase: N/A
• Start date: October 20, 2022
• Est. completion date: March 31, 2025

Study information

• Verified date: February 2023
• Source: University of California, Los Angeles
• Contact: Michael Delong, MD
• Phone: (310) 825-5510
• Email: mdelong[@]mednet.ucla.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 22 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Inflammation

Intervention

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.

Locations

Country	Name	City	State
United States	University of California Los Angeles	Los Angeles	California

Sponsors (4)

Lead Sponsor	Collaborator
University of California, Los Angeles	Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, University of Michigan, Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety - Major Complications	Relative rate of major complications (requiring unplanned re-admission or re-operation)	2 years
Primary	Effectiveness - BREASTQ	BREAST-Q validated patient reported questionnaire to assess results of final reconstruction.	2 years
Secondary	Secondary Effectiveness	Time from expander placement to implant exchange	2 years
Secondary	Secondary Safety	Individual complication rates	2 years
Secondary	Capsular Contracture	Rate of capsular contracture	2 years