A Study to Evaluate the Safety and Effectiveness of AlloMend® Acellular Dermal Matrix Used in Post Mastectomy Pre-Pectoral Breast Reconstruction and Followed for Up To 12-Months Post-Operatively
Status: Active_not_recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
SUMMARY
This retrospective, single-site study will provide information regarding the efficiency of AlloMend® Acellular Dermal Matrix allograft in Pre-Pectoral Breast Reconstruction surgery following a single or double mastectomy.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
⁃ Patients must meet the following inclusion criteria to participate in this study:
• Female ≥ 18 years old.
• Patients have undergone a single or double mastectomy, followed by AlloMend® Acellular Dermal Matrix -assisted, pre-pectoral breast reconstruction.
• Patients have undergone either one-stage (direct-to-implant) or two-stage (expander-to-implant), unilateral or bilateral pre-pectoral breast reconstruction using AlloMend®.
Locations
United States
Nevada
Janiga MDs Plastic Surgery and Cosmetic Center
Reno
Time Frame
Start Date: 2025-01-27
Completion Date: 2026-05-31
Participants
Target number of participants: 100
Related Therapeutic Areas
Sponsors
Leads: AlloSource