Recombinant Silk Hydrogel as a Novel Dermal Filler Component: Preclinical Safety and Efficacy Studies of a New Class of Tissue Fillers

Abstract Background Hyaluronic acid-based tissue fillers are commonly utilized in reconstructive surgery as well as for aesthetic augmentation. A new type of recombinant silk-based tissue filler might pose a beneficial alternative for surgeons and patients. Objectives The aim of this study was to co...

Full description

Saved in:
Bibliographic Details
Published in:Aesthetic surgery journal 2020-08, Vol.40 (9), p.511-518
Main Authors: Zeplin, Philip H, Sukhova, Inesa, Kranz, Alexander, Nürnberger, Tim, Mihalceanu, Silvia, Beescho, Christian, Schacht, Kristin, Vleugels, Matthias, Römer, Lin, Machens, Hans-Guenther, Duscher, Dominik
Format: Article
Language:English
Subjects:
Animals
Cosmetic Techniques
Dermal Fillers - adverse effects
Esthetics
Humans
Hyaluronic Acid - adverse effects
Hydrogels
Silk
Swine
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:Abstract Background Hyaluronic acid-based tissue fillers are commonly utilized in reconstructive surgery as well as for aesthetic augmentation. A new type of recombinant silk-based tissue filler might pose a beneficial alternative for surgeons and patients. Objectives The aim of this study was to compare injectability, reshaping, tolerability, and postimplantation behavior of dermal filler preparations containing recombinant silk hydrogel with a commercially available hyaluronic acid filler in 2 different animal models. Methods Recombinant silk hydrogel as standalone preparation or as a mixture with commercial stabilized hyaluronic acid was tested in rodent and porcine animal models. The preparations were analyzed in detail and administered subdermally followed by clinical, volumetric, and histological monitoring of the subdermal depots over several months. Results Applicability, dosing, and tissue distribution of the filler preparations were facilitated in the presence of silk hydrogel. No clinical complications attributable to tissue filler application were recorded. State-of-the art methods, such as high-performance magnetic resonance imaging, were applied successfully to monitor the volumetric development of the filler depots in live animals. Conclusions The preclinical data demonstrate the basic suitability of recombinant silk hydrogel as safe and convenient tissue filler ingredient. Due to its shear thinning properties, recombinant silk hydrogel has the potential for less painful application, comfortable aesthetic reshaping immediately after administration, and negligible postoperative discomfort.
ISSN:1090-820X
1527-330X
DOI:10.1093/asj/sjaa059