Randomized Feasibility Trial for Mesh in Pre-Pectoral Reconstruction

Launched by UNIVERSITY OF CALIFORNIA, LOS ANGELES · Jan 4, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the use of surgical mesh products, specifically acellular dermal matrices (ADM), in a type of breast reconstruction called pre-pectoral reconstruction. This technique places breast implants above the chest muscle, which is becoming more common among surgeons. The goal of the trial is to understand the risks and benefits of using these mesh products during the reconstruction process, as many surgeons currently use them without strong evidence supporting their safety and effectiveness.

To participate in this study, women aged 22 to 75 who are having immediate breast reconstruction (either on one side or both) with tissue expanders may be eligible. This includes women undergoing surgery for breast cancer or those choosing preventive mastectomies. Participants will receive either the surgical mesh or standard care during their reconstruction. It’s important to note that certain conditions, like poor skin quality or if the patient is pregnant, may prevent someone from joining the trial. This research could provide valuable insights into improving breast reconstruction procedures for women in the future.

Gender

FEMALE

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