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

NCT06853964 | Active Not Recruiting

• 1 other identifier: ADM2024-001
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pre-Pectoral Breast Reconstruction Following Mastectomy

Keywords

AlloMend; Acellular Dermal Matrix; Pre-pectoral Breast Reconstruction; Allografts

Outcome Measures

Primary Outcomes (1)

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

  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.

  Up to 12-month post-operatively

Secondary Outcomes (2)

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

  Up to 12-month post-operatively

• Retrospective Assessment of Patient-Reported Health Status and Quality of Life

  Up to 12 months

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients who require a single or double mastectomy and have undergone Pre-Pectoral Breast Reconstruction surgery with the use of AlloMend® Acellular Dermal Matrix allograft are eligible to participate. Patients who meet all the inclusion criteria but do not meet any of the exclusion criteria are eligible to enter the study.

You may qualify if:

• 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®.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AlloSource: lead

Study Sites (1)

Janiga MDs Plastic Surgery and Cosmetic Center

Reno, Nevada, 89521, United States

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: March 3, 2025
• Study Start: January 27, 2025
• Primary Completion: March 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)