Recruiting

AlloMend

Sponsor:

AlloSource

Code:

NCT06512259

Conditions

Pre-Pectoral Breast Reconstruction Following Single or Double Mastectomy

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

AlloMend® Acellular Dermal Matrix allograft

Study Details

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

Study ID

NCT06512259

Start date

Oct 19, 2023

Status verified date

Nov, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

  • 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.

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Interventions

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.

Primary outcome measure

  • Descriptive Data Collection [ Time Frame: Up to 6- months post-operatively ]

Central Contacts and Locations

Central contacts

Elizabeth Esterl, DNP, MS, RN

7207326231eesterl@allosource.org

Paige McHenry, MS, ATC, CCRA

2154997062pmchenry@allosource.org

Locations

Alan H. Chen Surgical Associates, PC

Recruiting

Joliet, Illinois, United States, 60435

Contacts

Ashtyn N Janovyak, MS, PA-C

ashtyn@alanchensurgery.com

Principal Investigator:

Alan Chen, MD

More Information

Sponsor

AlloSource

Last update posted

Nov 21, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by AlloSource on 2025-11-21.