Randomized Feasibility Trial for Mesh in Pre-Pectoral Reconstruction

Not Applicable

Recruiting

• Conditions: Breast Cancer; Breast Implant; Complications, Infection or Inflammation
• Interventions: Procedure: Reconstruction without ADM; Device: Acellular Dermal Matrix

• Registration Number: NCT05190978
• Lead Sponsor: University of California, Los Angeles

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

Study Timeline

• Study First Submitted: 2022-01-04
• Study First Submitted QC: 2022-01-04
• Study First Posted: 2022-01-13
• Study Start: 2022-10-20
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-20
• Last Update Posted: 2025-03-25
• Primary Completion: 2026-04-30
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Reconstruction without ADM	Patients will not receive ADM during their initial tissue expander placement.
Acellular Dermal Matrix	Acellular Dermal Matrix	Patients will receive ADM during their initial tissue expander placement.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Capsular Contracture	2 years	Rate of capsular contracture
Secondary Safety	2 years	Individual complication rates
Secondary Effectiveness	2 years	Time from expander placement to implant exchange

Trial Locations

Locations (1)

University of California Los Angeles; 🇺🇸 Los Angeles, California, United States