AlloMend Acellular Dermal Matrix Allograft in Pre-Pectoral Breast Reconstruction

Last updated: January 29, 2025
Sponsor: AlloSource
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

AlloMend® Acellular Dermal Matrix allograft

Clinical Study ID

NCT06512259
ADM2023-001
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

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 byPre-Pectoral Breast Reconstruction surgery with the use of AlloMend® AcellularDermal Matrix allograft;

  • Surgical intervention using AlloMend® Acellular Dermal Matrix allograft was used;

  • Has completed or will complete the anticipated clinically indicated follow-up visitsat 2 weeks, 6 weeks, 3 months, and 6 months post-surgical intervention.

Exclusion

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-pectoralbreast reconstruction

  • Did not have post-operative evaluations at the clinical site.

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: AlloMend® Acellular Dermal Matrix allograft
Phase:
Study Start date:
October 19, 2023
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Alan H. Chen Surgical Associates, PC

    Joliet, Illinois 60435
    United States

    Active - Recruiting

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