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Feasibility Trial for Mesh in Pre-Pectoral Breast Reconstruction

This study is looking at whether using a surgical mesh product called Acellular Dermal Matrix (ADM) is helpful when women have breast reconstruction after a mastectomy. Many surgeons use ADM, but there isn't much strong evidence about its risks and benefits, especially when implants are placed above the chest muscle (pre-pectoral reconstruction). This study will compare patients who receive ADM with those who do not. We want to understand if ADM is safe and if it improves how women feel about their reconstruction. You may be able to join if you are a woman between 22 and 75 years old, having immediate pre-pectoral breast reconstruction with tissue expanders after a mastectomy. The study aims to enroll 120 participants. The current recruitment status is unclear.

Study design
This is a randomized study, meaning participants are assigned by chance to either receive Acellular Dermal Matrix or not. It plans to enroll 120 women.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety and effectiveness for 2 years after their reconstruction.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05190978

Randomized Feasibility Trial for Mesh in Pre-Pectoral Reconstruction

Recruiting
NAAges 22–75InterventionalTreatment
University of California, Los Angeles
~120 participants
Updated 2026-05-05 on ClinicalTrials.gov
What's tested:Acellular Dermal MatrixReconstruction without ADM

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety - Major Complications
Measured over 2 years
+1 more outcome measured

Conditions

Breast Cancer
Breast Implant; Complications, Infection or Inflammation

Explore related trials

Breast CarcinomaMammoplasty

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Michael Delong, MD · PRINCIPAL_INVESTIGATOR · University of California, Los Angeles

Who to contact

Michael Delong, MD
[email protected]
(310) 825-5510
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Safety - Major Complications2 years

    Relative rate of major complications (requiring unplanned re-admission or re-operation)

  • Effectiveness - BREASTQ2 years

    BREAST-Q validated patient reported questionnaire to assess results of final reconstruction.