In vivo safety and efficacy of sericin/poly(vinyl alcohol)/glycerin scaffolds fabricated by freeze-drying and salt-leaching techniques for wound dressing applications

In our previous works, two techniques (freeze-drying and salt-leaching) were introduced to fabricate the sericin/poly(vinyl alcohol)/glycerin scaffolds. The freeze-dried and salt-leached sericin/poly(vinyl alcohol)/glycerin scaffolds with the same composition showed distinguished physical and in vitro biological characteristics. In this study, the in vivo safety and efficacy tests of both scaffolds as dressing materials for the healing of full-thickness wounds in rat model were performed in comparison with the clinically used dressing, Allevyn^®. In the safety test, the scaffolds were implanted subcutaneously, and the signs of tissue irritation including the extent of inflammatory cells, calcification, vascularization, and fatty infiltration were scored. In the efficacy test, the scaffolds were applied to the full-thickness wound (1.5 cm × 1.5 cm), and the epithelialization and collagen formation in the wound were evaluated. Both freeze-dried and salt-leached scaffolds were characterized as non- to slightly irritant implantable materials. The freeze-dried scaffold minimally causes irritation to the tissue possibly because it was derived from the non-chemical relevant process. Furthermore, the freeze-dried scaffold showed the highest wound healing efficiency as characterized by the fastest epithelialization and highest extent of collagen formation. This might be due to the more sustained release of sericin from the freeze-dried scaffold, compared to that of the salt-leached scaffold. Therefore, fabrication process seemed to directly regulate the properties and applicability of the scaffolds. The safety and efficacy of the dressing materials in wound healing application depended not only on the materials themselves but also on the fabrication process that produces them.