Reshapable polymeric hydrogel for controlled soft-tissue expansion: In vitro and in vivo evaluation

Tissue expansion is the process by which extra skin is generated using a device that applies pressure from underneath the skin. Over the course of weeks to months, stretching by this pressure creates a flap of extra tissue that can be used to cover a defect area or enclose a permanent implant. Conventional tissue expanders require a silicone shell inflated either by external injections of saline solution or air, or by internal osmotic pressure generated by a hydrophilic polymer. In this study, a shell-free tissue expander comprised only of a chemically cross-linked biocompatible polymeric hydrogel is developed. The cross-linked network of hydrophilic polymer provides for intrinsically controlled swelling in the absence of an external membrane. The new type of hydrogel expanders were characterized in vitro as well as in vivo using a rat-skin animal model. It was found that increasing the hydrophobic polyester content in the hydrogel reduced the swelling velocity to a rate and volume that eliminate the danger of premature swelling rupturing the sutured area. Additionally, increasing the crosslinking density resulted in enough mechanical strength of the hydrogel to allow for complete post-swelling removal, without the hydrogel cracking or crumbling. No systemic toxicity was noted with the expanders and histology showed the material to be highly biocompatible. These expanders have an advantage of tissue expansion without requiring an external silicone membrane, and thus, they can be cut or reshaped at the time of implantation for applications in small or physically constrained regions of the body.