AlloMend Acellular Dermal Matrix Allograft in Pre-Pectoral Breast Reconstruction

NCT06512259 | Recruiting

• 1 other identifier: ADM2023-001
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pre-Pectoral Breast Reconstruction Following Single or Double Mastectomy

Outcome Measures

Primary Outcomes (1)

• Descriptive Data Collection

  The primary objective is to obtain descriptive data and surgical intervention and post operative surgical outcome data on AlloMend® Acellular Dermal Matrix allograft for patients that have undergone Pre-Pectoral Breast Reconstruction surgery following a single or double mastectomy.

  Up to 6- months post-operatively

Secondary Outcomes (1)

• Physical Function and Quality of Life

  Up to 6- months post-operatively

Other Outcomes (1)

• Qualitative Data

  Up to 6- months post-operatively

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+
• Gender Eligibility Details: 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.
• 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 a Pre-Pectoral Breast Reconstruction surgery with the use of AlloMend® Acellular Dermal Matrix allograft are eligible to participate. Patients who meet all of the inclusion criteria but do not meet any of the exclusion criteria are eligible to enter the study.

You may qualify if:

• 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.

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)

Alan H. Chen Surgical Associates, PC

Joliet, Illinois, 60435, United States

RECRUITING

Central Study Contacts

Elizabeth Esterl, DNP, MS, RN

CONTACT

7207326231; eesterl@allosource.org

Paige McHenry, MS, ATC, CCRA

CONTACT

2154997062; pmchenry@allosource.org

Study Design

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

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: July 22, 2024
• Study Start: October 19, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 21, 2025

Record last verified: 2025-11

Locations

US (1)