AlloMend Acellular Dermal Matrix Allograft in Pre-Pectoral Breast Reconstruction

AlloSource200 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Pre-Pectoral Breast Reconstruction Following Single or Double Mastectomy

Interventions

AlloMend® Acellular Dermal Matrix allograftOTHER

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Alan H. Chen Surgical Associates, PC

Joliet, Illinois, United States

RECRUITING

Outcomes

Primary Outcomes

Descriptive Data Collection

The primary objective is to obtain descriptive data and surgical intervention and post operative surgical outcome data on AlloMend® Acellular Dermal Matrix allograft for patients that have undergone Pre-Pectoral Breast Reconstruction surgery following a single or double mastectomy.

Time frame: Up to 6- months post-operatively

Secondary Outcomes

Physical Function and Quality of Life

Secondary Objectives will identify changes in physical function and quality of life as assessed for a period of 6-months post-operatively.

Time frame: Up to 6- months post-operatively

Central Contacts

Elizabeth Esterl, DNP, MS, RN

CONTACT

7207326231 eesterl@allosource.org

Paige McHenry, MS, ATC, CCRA

CONTACT

2154997062 pmchenry@allosource.org

Data from ClinicalTrials.gov

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