Clinical Trials in the USA / NCT05744414
Active, not recruiting
Observational
Histological Analysis of AlloMend® Acellular Dermal Matrix Used in Breast Implant Surgeries
NCT05744414 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Breast Implant; Complications, Infection or Inflammation
Study 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.
Eligibility
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.
Primary outcome measure(s)
- 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.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Janiga MDs Plastic Surgery and Cosmetic Center | Reno | Nevada |
More AlloSource trials in the USA
Prospective Evaluation of ProChondrix CR for Repair of Articular Cartilage Defects on Femoral Condyle and Patella
Active, not recruiting
Retrospective Study of AlloMend Acellular Dermal Matrix (ADM) Allograft and Pre-Pectoral Breast Reconstruction
Active, not recruiting
Effectiveness of AlloWrap® for the Reduction of Inflammation in ACDF Procedures
Enrolling by invitation
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05744414 on ClinicalTrials.gov ↗ ← All trials in the USA