NCT05744414

Histological Analysis of AlloMend® Acellular Dermal Matrix Used in Breast Implant Surgeries

Histological Analysis of AlloMend® Acellular Dermal Matrix Used During the Initial Pre Pectoral Placement of Tissue Expanders for Breast Reconstruction and Evaluated at Time of Permanent Breast Implantation

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: AlloSource · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a prospective, histologic analysis of biopsied tissue obtained from participants who have undergone a pre-pectoral breast reconstruction or augmentation surgery with expander placement and AlloMend® Acellular Dermal Matrix. AlloMend® Acellular Dermal Matrix graft incorporation with surrounding native soft tissue using histological assays characterizing host cell infiltration, neovascularization, inflammation, and host replacement of ADM collagen will be studied.

Detailed description

The purpose of this study is to evaluate the incorporation of AlloMend® Acellular Dermal Matrix with native surrounding tissue by obtaining up to three, 1 cm diameter biopsies per breast. The samples will then be transported to AlloSource Research and Development Labs for slide preparation and histologic analysis. This study will be performed at one (1) clinical center in the United States.

Conditions

• Breast Implant; Complications, Infection or Inflammation

Timeline

• Start date: 2023-05-17
• Primary completion: 2026-03-01
• Completion: 2026-05-01
• First posted: 2023-02-27
• Last updated: 2025-11-21

Locations

1 site across 1 country: United States