Evaluating the use of surgical mesh in breast reconstruction
Official title: Randomized Feasibility Trial for Mesh in Pre-Pectoral Reconstruction
Run by University of California, Los Angeles · NCT05190978 · Data updated 2026-11-12
This study is testing if using surgical mesh can improve the results of breast reconstruction for women who are having surgery right after a mastectomy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 22 Years to 75 Years |
| Sex | Women only |
| Enrollment | 120 (estimated) |
| Sponsor | University of California, Los Angeles Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Status | Recruiting |
| Started | October 20, 2022 |
| Main results expected | April 30, 2027 |
| Study ends | April 30, 2027 |
| Registry record updated | May 5, 2026 |
| Trial ID | NCT05190978 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are female patients aged 22 to 75 who are undergoing unilateral or bilateral immediate pre-pectoral reconstruction with tissue expanders.
✕Probably not a fit
Patients who may not benefit include those with unfavorable intraoperative conditions for immediate reconstruction, those undergoing contralateral submuscular reconstruction, or those who are pregnant.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This pilot study is a randomized multi-center trial aimed at assessing the effectiveness and safety of using surgical mesh, specifically acellular dermal matrices, in pre-pectoral breast reconstruction. The study will involve female patients undergoing immediate reconstruction after mastectomy, comparing outcomes between those receiving mesh assistance and those who do not. By addressing the risks and benefits of this approach, the trial seeks to provide critical data that could influence future practices in breast reconstruction. The research is particularly timely given the increasing reliance on these devices without robust evidence of their efficacy.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety and effectiveness of surgical mesh in breast reconstruction, potentially improving patient outcomes.
How similar studies have gone: While this approach is novel in the context of randomized trials for mesh in breast reconstruction, previous studies have highlighted the need for rigorous evaluation of such devices.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
University of California Los Angeles
Los Angeles, California, United States Recruiting
Study contacts
- Principal investigator: Michael Delong, MD — University of California, Los Angeles
- Study coordinator: Michael Delong, MD
- Email: mdelong@mednet.ucla.edu
- Phone: (310) 825-5510
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.