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

Recruiting

• Conditions: Pre-Pectoral Breast Reconstruction Following Mastectomy

• Registration Number: NCT06853964
• Lead Sponsor: AlloSource

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2024-11-19
• Study Start: 2025-01-27
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-25
• Last Update Submitted: 2025-02-28
• Study First Posted: 2025-03-03
• Last Update Posted: 2025-03-04
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Retrospective Analysis of Clinical and Surgical Outcomes in Pre-Pectoral Breast Reconstruction with AlloMend®	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 Outcome Measures

Name	Time	Method
Retrospective Assessment of Patient-Reported Health Status and Quality of Life	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.
Retrospective Evaluation of Follow-Up Clinical, Imaging, and Surgical Outcomes	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.

Trial Locations

Locations (1)

Janiga MDs Plastic Surgery and Cosmetic Center; 🇺🇸 Reno, Nevada, United States