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

The primary objective of this study is to histologically evaluate the incorporation of AlloMend® Acellular Dermal Matrix into surrounding native soft tissue. 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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Breast Implant; Complications, Infection or Inflammation

• Study Type: Observational
• Enrollment (Estimated): 15

Contacts and Locations

• Study Contact: Name: Claire McFadyen, MPH; Phone Number: 719-431-3641; Email: cmcfadyen@allosource.org
• Study Contact Backup: Name: Elizabeth Esterl, DNP, MS, RN; Phone Number: 720-873-4811; Email: eesterl@allosource.org

Study Locations

• United States
  • Nevada
    • Reno, Nevada, United States, 89521
      • Janiga MDs Plastic Surgery and Cosmetic Center
      • Contact: Timothy Janiga, MD; Phone Number: 775-364-0224

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
ADM incorporation with native tissue	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.	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): May 1, 2024
• Study Completion (Estimated): May 1, 2024

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): January 12, 2024
• Last Update Submitted That Met QC Criteria: January 11, 2024
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• 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