AlloMend Acellular Dermal Matrix Allograft in Pre-Pectoral Breast Reconstruction

A Retrospective 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 6-Months Post-Operatively.

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.

Study Overview

• Status: Recruiting
• Conditions: Pre-Pectoral Breast Reconstruction Following Single or Double Mastectomy
• Intervention / Treatment: Other: AlloMend® Acellular Dermal Matrix allograft

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Elizabeth Esterl, DNP, MS, RN; Phone Number: 7207326231; Email: eesterl@allosource.org
• Study Contact Backup: Name: Paige McHenry, MS, ATC, CCRA; Phone Number: 2154997062; Email: pmchenry@allosource.org

Study Locations

• United States
  • Illinois
    • Joliet, Illinois, United States, 60435
      • Recruiting
      • Alan H. Chen Surgical Associates, PC
      • Principal Investigator: Alan Chen, MD
      • Contact: Ashtyn N Janovyak, MS, PA-C; Email: ashtyn@alanchensurgery.com
      • Sub-Investigator: Ashtyn N Janovyak, MS, PA-C

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients who require a single or double mastectomy and have undergone a Pre-Pectoral Breast Reconstruction surgery with the use of AlloMend® Acellular Dermal Matrix allograft are eligible to participate. Patients who meet all of the inclusion criteria but do not meet any of the exclusion criteria are eligible to enter the study.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 6- months post-operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 6- months post-operatively

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitative Data	Qualitative data such as return to wound healing, pain, discomfort, physicial deformity, and revision surgeries will also be collected.	Up to 6- months post-operatively

Collaborators and Investigators

• Sponsor: AlloSource

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: July 16, 2024
• First Submitted That Met QC Criteria: July 16, 2024
• First Posted (Actual): July 22, 2024

Study Record Updates

• Last Update Posted (Actual): November 21, 2025
• Last Update Submitted That Met QC Criteria: November 20, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: ADM2023-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No