J Breast Cancer.  2020 Dec;23(6):635-646. 10.4048/jbc.2020.23.e64.

In Vitro Analysis of Histology, Mechanics, and Safety of Radiationfree Pre-hydrated Human Acellular Dermal Matrix

Affiliations
  • 1Department of Surgery, Ajou University Hospital, Suwon, Korea
  • 2Department of Plastic and Reconstructive Surgery, Ajou University School of Medicine, Suwon, Korea
  • 3CGBio Co. Ltd., Seoul, Korea

Abstract

Purpose
Acellular dermal matrix (ADM) supports tissue expanders or implants in implant-based breast reconstruction. The characteristics of ADM tissue are defined by the manufacturing procedure, such as decellularization, preservation, and sterilization, and are directly related to clinical outcomes. This study aimed to compare the properties of a new pre-hydrated-ADM (H-ADM-low) obtained using a decellularization reagent reduction process with a low concentration of detergent with those of radiation-sterilized H-ADM and freeze-dried ADM (FD-ADM).
Methods
ADMs were evaluated in terms of structure, mechanical quality, and cytotoxicity using histochemical staining, tensile strength testing, and in vitro cell viability analysis.
Results
The tissue structure of H-ADM-low (CGDERM ONE-STEP) was similar to that of native skin despite complete decellularization. By contrast, in FD-ADM, the tissue structure was damaged by the freeze-drying process, and radiation-sterilized H-ADM showed a compact fibrillar arrangement. Furthermore, matrix components such as collagen and elastin were preserved in H-ADM-low, whereas a loss of elastin fibers with fragmented distribution was observed in radiation-sterilized H-ADMs. H-ADM-low's tensile strength (58.84 MPa) was significantly greater than that of FD-ADM (38.60 MPa) and comparable with that of radiationsterilized H-ADMs. The residual detergent content in H-ADM-low (47.45 mg/L) was 2.67-fold lower than that of H-ADM decellularized with a conventional detergent concentration (126.99 mg/mL), and this finding was consistent with the cell viability results (90.7% and 70.7%, respectively), indicating that H-ADM-low has very low cytotoxicity.
Conclusions
H-ADM-low produced through aseptic processes retains the original tissue structure, demonstrates excellent mechanical properties, and does not affect cell viability. Therefore, this newer H-ADM is suitable for use in implant-based breast reconstruction.

Keyword

Acellular dermis; Biological preservation; Breast implantation; Detergents; In vitro techniques
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