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

Active, not recruiting

• Conditions: Breast Implant; Complications, Infection or Inflammation

• Registration Number: NCT05744414
• Lead Sponsor: AlloSource

Brief Summary

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.

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 Timeline

• Study First Submitted: 2023-02-09
• Study First Submitted QC: 2023-02-15
• Study First Posted: 2023-02-27
• Study Start: 2023-05-17
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-16
• Last Update Posted: 2025-05-18
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
AlloMend® Acellular Dermal Matrix graft incorporation when used in a soft tissue application	At expander/implant exchange surgery; typically 1-3 months post expander placement	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Janiga MDs Plastic Surgery and Cosmetic Center; 🇺🇸 Reno, Nevada, United States