AlloMend Acellular Dermal Matrix Allograft in Pre-Pectoral Breast Reconstruction

Recruiting

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

• Registration Number: NCT06512259
• Lead Sponsor: AlloSource

Brief Summary

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.

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 Timeline

• Study Start: 2023-10-19
• Study First Submitted: 2024-07-16
• Study First Submitted QC: 2024-07-16
• Study First Posted: 2024-07-22
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-29
• Last Update Posted: 2025-01-31
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Descriptive Data Collection	Up to 6- months post-operatively	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.

Secondary Outcome Measures

Name	Time	Method
Physical Function and Quality of Life	Up to 6- months post-operatively	Secondary Objectives will identify changes in physical function and quality of life as assessed for a period of 6-months post-operatively.

Trial Locations

Locations (1)

Alan H. Chen Surgical Associates, PC; 🇺🇸 Joliet, Illinois, United States