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NCT Number: NCT06853964

Retrospective Study of AlloMend Acellular Dermal Matrix (ADM) Allograft and Pre-Pectoral Breast Reconstruction

This retrospective, single-site study will provide information regarding the efficiency of AlloMend® Acellular Dermal Matrix allograft in Pre-Pectoral Breast Reconstruction surgery following a single or double mastectomy.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Pre-Pectoral Breast Reconstruction Following Mastectomy

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Janiga MDs Plastic Surgery and Cosmetic Center

Reno, Nevada, 89521, United States

About this study

AlloMend® Acellular Dermal Matrix AlloMend® 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.

This retrospective study will be performed at one center in the United States.

Information from the preoperative clinical visit and Pre-Pectoral Breast Reconstruction surgery utilizing AlloMend® Acellular Dermal Matrix allograft, approximately 200 breasts (and up to 100 patients), and the follow-up clinical visits at approximately 2 weeks, 6 weeks, 3 months, 6 months, and 12 months, including clinical assessments, imaging, and patient-reported outcomes, will be collected.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients must meet the following inclusion criteria to participate in this study:

Female ≥ 18 years old.
Patients have undergone a single or double mastectomy, followed by AlloMend® Acellular Dermal Matrix -assisted, pre-pectoral breast reconstruction.
Patients have undergone either one-stage (direct-to-implant) or two-stage (expander-to-implant), unilateral or bilateral pre-pectoral breast reconstruction using AlloMend®.

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.

Treatment and study plan

AlloMend® Acellular Dermal Matrix allograft

Other

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.

Primary outcomes

Retrospective Analysis of Clinical and Surgical Outcomes in Pre-Pectoral Breast Reconstruction with AlloMend®

Time frame: Up to 12-month post-operatively

This primary outcome measure will retrospectively collect descriptive data on patients who have undergone single or double mastectomy followed by pre-pectoral breast reconstruction using AlloMend® Acellular Dermal Matrix allograft. Data will be extracted from medical records and will include patient demographics, medical history, surgical techniques, intraoperative and postoperative complications, prescribed medications, and adjuvant treatments such as chemotherapy and radiation. The objective is to characterize patient profiles, surgical outcomes, and potential complications associated with this reconstructive approach.

Secondary outcomes

Retrospective Evaluation of Follow-Up Clinical, Imaging, and Surgical Outcomes

Time frame: Up to 12-month post-operatively

This outcome measure will retrospectively assess post-treatment follow-up data, including physical examinations, imaging findings, physical therapy progress, and the incidence of revision surgery. Data will be extracted from patient records to evaluate recovery progress, functional improvements, and any complications or need for additional interventions.
Retrospective Assessment of Patient-Reported Health Status and Quality of Life

Time frame: Up to 12 months

This outcome measure will retrospectively evaluate patients' self-reported overall health status and quality of life following surgical intervention. Data will be collected from existing medical records, including patient-reported responses and clinical interviews, to assess perceived well-being, functional limitations, pain levels, and overall satisfaction with treatment outcomes. No specific tool was used to gather their responses.

Sponsors and collaborators

Lead sponsor

AlloSource

Industry

Registry information

Official study title

A 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 12-Months Post-Operatively

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Mar 3, 2025
Registry last updated: Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.