Pre-pectoral Tissue Expander and Acellular Dermal Matrix for a Two-stage Muscle Sparing Breast Reconstruction

Launched by ROSSELLA ELIA, MD PHD · Apr 16, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new approach to breast reconstruction for women who have had a mastectomy due to breast cancer. The researchers are looking at a method called "two-stage muscle sparing prepectoral breast reconstruction." This means that instead of placing the tissue expander (a temporary device to create breast shape) under the chest muscle, it will be placed above it and covered with a special material called Acellular Dermal Matrix (ADM). The goal is to understand how well this method works and to develop guidelines to help doctors decide the best way to perform breast reconstruction immediately after surgery.

To participate in this trial, women who have undergone either one or both breasts being removed (mastectomy) and are planning for breast reconstruction using this specific approach may be eligible. However, women who have had certain other types of breast surgery or specific reconstruction techniques that involve muscles may not qualify. Participants can expect to receive careful monitoring and support throughout the study, and they'll help provide important information that could improve breast reconstruction options for future patients.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • unilateral or bilateral mastectomy followed by two stage breast reconstruction with subcutaneous tissue expander and Acellular Dermal Matrix (ADM)
• • risk-reducing mastectomies followed by two stage breast reconstruction with subcutaneous tissue expander and ADM
• Exclusion Criteria:
• • partial or total submuscular tissue expander placement,
• • tissue expander placement in conjunction with latissimus dorsi muscle flap or without ADM, -delayed reconstructions
• • previous breast surgery