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RecruitingNot applicable

Randomized Feasibility Trial for Mesh in Pre-Pectoral Reconstruction

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
22 Years to 75 Years
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the risks and benefits of surgical mesh in breast rebuilding with implants placed above the chest muscle. It is for women ages 22 to 75 having one or both breasts rebuilt right after breast removal, using temporary expanders before implants.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Women ages 22 to 75.
  • Having one or both breasts rebuilt above the chest muscle right after breast removal, using tissue expanders (temporary devices that make room for implants).
  • Breast removal may be to treat cancer or help prevent it.
  • Breast removal that keeps the nipple or breast skin is allowed.

Who can't join

  • During surgery, the surgeon finds that skin left after breast removal is too thin or not healthy enough to rebuild either breast above the chest muscle right away.
  • Having both breasts rebuilt, with an implant placed under the chest muscle on the other side.
  • Getting a breast implant directly, without first using a tissue expander.
  • Being pregnant.
  • Having breast rebuilding later, rather than right after breast removal.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

CA