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

Running, not enrolling

Conditions studied: Breast Implant; Complications, Infection or Inflammation

In brief

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.

Key facts

Study ID

NCT05744414

Run by

AlloSource

People needed

30

Starts

2023-05-17

Expected to finish

2026-05-01

Last updated by the study team

2025-11-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

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

Full record on ClinicalTrials.gov

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