Evaluating the use of surgical mesh in breast reconstruction
Randomized Feasibility Trial for Mesh in Pre-Pectoral Reconstruction
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 22 Years to 75 Years |
| Sex | Female |
| Sponsor | University of California, Los Angeles Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT05190978 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are female patients aged 22 to 75 who are undergoing unilateral or bilateral immediate pre-pectoral reconstruction with tissue expanders.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Los Angeles, California
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.