NCT06853964

Retrospective Study of AlloMend Acellular Dermal Matrix (ADM) Allograft and Pre-Pectoral Breast Reconstruction

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
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: AlloSource · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

AlloMend® Acellular Dermal Matrix AlloMend® is a sterile, ready-to-use, human-derived acellular dermal matrix (ADM) allograft that can be used in a number of reconstructive and other surgical procedures. It is made from donated human full-thickness skin. After the epidermal and hypodermal layers are removed, the tissue is treated by a proprietary cleansing process. AlloMend® is intended to be used in conjunction with a breast implant or tissue expander to stabilize implant position and minimize implant loss during post-single or double mastectomy, unilateral or bilateral pre-pectoral breast reconstruction in women 18 years of age or older. AlloMend® may be used in either one-stage (direct-to-implant) or two-stage (expander-to-implant) procedures. This retrospective study will be performed at one center in the United States. Information from the preoperative clinical visit and Pre-Pectoral Breast Reconstruction surgery utilizing AlloMend® Acellular Dermal Matrix allograft, approximately 200 breasts (and up to 100 patients), and the follow-up clinical visits at approximately 2 weeks, 6 weeks, 3 months, 6 months, and 12 months, including clinical assessments, imaging, and patient-reported outcomes, will be collected.

Conditions

• Pre-Pectoral Breast Reconstruction Following Mastectomy

Interventions

Type	Name	Description
OTHER	AlloMend® Acellular Dermal Matrix allograft	AlloSource, a non-profit supplier of allografts and one of the nation's leading tissue banks, introduced AlloMend® Acellular Dermal Matrix allograft to bring the benefits of regenerative medicine to more patients. cellular allograft matrices, unlike synthetic materials or xenografts, are recognized as human tissue by the body for graft incorporation by the recipient, minimizing the risk of inflammation or rejection. AlloMend® Acellular Dermal Matrix allograft has been shown to incorporate into the surgical site and demonstrates blood vessel infiltration.

Timeline

• Start date: 2025-01-27
• Primary completion: 2026-03-31
• Completion: 2026-05-31
• First posted: 2025-03-03
• Last updated: 2025-11-21

Locations

1 site across 1 country: United States