AlloMend Acellular Dermal Matrix Allograft in Pre-Pectoral Breast Reconstruction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-19

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pre-Pectoral Breast Reconstruction Following Single or Double Mastectomy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Interventions

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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 the surgical site and demonstrates blood vessel infiltration.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No