AlloMend Acellular Dermal Matrix Allograft in Pre-Pectoral Breast Reconstruction

AlloSource

Status: Enrolling

Conditions: Pre-Pectoral Breast Reconstruction Following Single or Double Mastectomy

Treatments: Other: AlloMend® Acellular Dermal Matrix allograft

Study type: Observational

Funder types: Industry

Identifiers

NCT06512259

ADM2023-001

Details and patient eligibility

About

This is a single-center, retrospective study which will be used to describe and evaluate the effectiveness of AlloMend® Acellular Dermal Matrix allograft for patients that have undergone Pre-Pectoral Breast Reconstruction surgery following a single or double mastectomy.

Full description

AlloMend® Acellular Dermal Matrix 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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients must meet the following inclusion criteria to participate in this study:

• Diagnosed by a physician and required a single or double mastectomy followed by Pre-Pectoral Breast Reconstruction surgery with the use of AlloMend® Acellular Dermal Matrix allograft;
• Surgical intervention using AlloMend® Acellular Dermal Matrix allograft was used;
• Has completed or will complete the anticipated clinically indicated follow-up visits at 2 weeks, 6 weeks, 3 months, and 6 months post-surgical intervention.

Exclusion criteria

Patients must not meet any of the following criteria to be considered for this clinical trial:

• Did not utilize AlloMend® Acellular Dermal Matrix allograft during pre-pectoral breast reconstruction
• Did not have post-operative evaluations at the clinical site.