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Recruiting NCT06512259

AlloMend Acellular Dermal Matrix Allograft in Pre-Pectoral Breast Reconstruction

— Observational Pre-Pectoral Breast Reconstruction Following Single or Double Mastectomy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AlloMend® Acellular Dermal Matrix allograft.
Who it may be relevant to
Registry conditions: Pre-Pectoral Breast Reconstruction Following Single or Double Mastectomy. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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.

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.

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.

Interventions

  • Other AlloMend® Acellular Dermal Matrix allograft
    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 t

Primary outcome measures

  • Descriptive Data Collection [Time frame: Up to 6- months post-operatively]
Secondary outcome measures (1)
  • Physical Function and Quality of Life [Time frame: Up to 6- months post-operatively]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

United States · 1 center
  • Alan H. Chen Surgical Associates, PC — Joliet

Identifiers

NCT: NCT06512259 · ADM2023-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗