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

NCT05744414 | Active Not Recruiting

• 1 other identifier: ADM-002
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Implant; Complications, Infection or Inflammation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Infection rates

  Up to 6 months post expander/implant exchange

• Seroma rates

  Up to 6 months post expander/implant exchange

• Hematoma rates

  Up to 6 months post expander/implant exchange

• Drain outputs and timing of drain removal

  Up to 6 months post expander/implant exchange

• Revision surgeries

  Up to 6 months post expander/implant exchange

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• ≥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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AlloSource: lead

Study Sites (1)

Janiga MDs Plastic Surgery and Cosmetic Center

Reno, Nevada, 89521, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

At the time of exchange of tissue expanders to permanent breast implant, tissue specimens of AlloMend® Acellular Dermal Matrix and native tissue will be obtained from eligible and consented patients for histological analysis.

MeSH Terms

Conditions

Infections; Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2023
• First Posted: February 27, 2023
• Study Start: May 17, 2023
• Primary Completion: March 1, 2026
• Study Completion: May 1, 2026
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)