Histological Analysis of AlloMend® Acellular Dermal Matrix Used in Breast Implant Surgeries

Histological Analysis of AlloMend® Acellular Dermal Matrix Used During the Initial Pre Pectoral Placement of Tissue Expanders for Breast Reconstruction and Evaluated at Time of Permanent Breast Implantation

This is a prospective, histologic analysis of biopsied tissue obtained from participants who have undergone a pre-pectoral breast reconstruction or augmentation surgery with expander placement and AlloMend® Acellular Dermal Matrix.

AlloMend® Acellular Dermal Matrix graft incorporation with surrounding native soft tissue using histological assays characterizing host cell infiltration, neovascularization, inflammation, and host replacement of ADM collagen will be studied.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Implant; Complications, Infection or Inflammation

Detailed Description

The purpose of this study is to evaluate the incorporation of AlloMend® Acellular Dermal Matrix with native surrounding tissue by obtaining up to three, 1 cm diameter biopsies per breast. The samples will then be transported to AlloSource Research and Development Labs for slide preparation and histologic analysis.

This study will be performed at one (1) clinical center in the United States.

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

Study Locations

• United States
  • Nevada
    • Reno, Nevada, United States, 89521
      • Janiga MDs Plastic Surgery and Cosmetic Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Adults 18 years of age or greater who have undergone a pre-pectoral placement of tissue expanders for breast reconstruction and will have a histological evaluation of the AlloMend® Acellular Dermal Matrix and native tissue at time of permanent breast implantation

Description

Inclusion Criteria:

• ≥18 years of age;
• AlloMend® Acellular Dermal Matrix used during the initial prepectoral placement of tissue expanders for breast reconstruction;
• Is scheduled or will be scheduled for a procedure to exchange the tissue expander for permanent breast implant;
• Can understand the requirements of the study, has provided written, informed consent, and to comply with the study protocol.

Exclusion Criteria:

• Mentally compromised (e.g., being currently treated for a psychiatric disorder, senile dementia, Alzheimer's disease) in a manner that would compromise his or her ability to consent to participate in the clinical study;
• Subjects who, in the opinion of the investigator, would not be able or willing to comply with the protocol.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AlloMend® Acellular Dermal Matrix graft incorporation when used in a soft tissue application	The primary endpoint being evaluated in this study is AlloMend® Acellular Dermal Matrix graft incorporation when used in a soft tissue application. The endpoint will be analyzed from biopsied tissue samples taken during the exchange of expander to permanent breast implant using histological assays characterizing host cell infiltration, neovascularization, inflammation, and host replacement of ADM collagen.	At expander/implant exchange surgery; typically 1-3 months post expander placement

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infection rates	Information collected through clinical standard of care	Up to 6 months post expander/implant exchange
Seroma rates	Information collected through clinical standard of care	Up to 6 months post expander/implant exchange
Hematoma rates	Information collected through clinical standard of care	Up to 6 months post expander/implant exchange
Drain outputs and timing of drain removal	Information collected through clinical standard of care	Up to 6 months post expander/implant exchange
Revision surgeries	Information collected through clinical standard of care	Up to 6 months post expander/implant exchange

Collaborators and Investigators

• Sponsor: AlloSource

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2023
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: February 9, 2023
• First Submitted That Met QC Criteria: February 15, 2023
• First Posted (Actual): February 27, 2023

Study Record Updates

• Last Update Posted (Actual): November 21, 2025
• Last Update Submitted That Met QC Criteria: November 20, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Inflammation; Infections
• Other Study ID Numbers: ADM-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No