Status:
RECRUITING
Randomized Feasibility Trial for Mesh in Pre-Pectoral Reconstruction
Lead Sponsor:
University of California, Los Angeles
Collaborating Sponsors:
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Weill Medical College of Cornell University
Conditions:
Breast Cancer
Breast Implant; Complications, Infection or Inflammation
Eligibility:
FEMALE
22-75 years
Phase:
NA
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 ...
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 re...
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
Key Trial Info
Start Date :
October 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05190978
Start Date
October 20 2022
End Date
April 30 2026
Last Update
March 25 2025
Active Locations (1)
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1
University of California Los Angeles
Los Angeles, California, United States, 90095