Randomized Clinical Trial of the Innovative Bilayered Wound Dressing Made of Silk and Gelatin: Safety and Efficacy Tests Using a Split-Thickness Skin Graft Model.

Sukhontha Hasatsri,Pornanong Aramwit,Apichai Angspatt

doi:10.1155/2015/206871

Sukhontha Hasatsri, Pornanong Aramwit + Show 1 more

Open Access

https://doi.org/10.1155/2015/206871

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Abstract

We developed the novel silk fibroin-based bilayered wound dressing for the treatment of partial thickness wounds. And it showed relevant characteristics and accelerated the healing of full-thickness wounds in a rat model. This study is the clinical evaluation of the bilayered wound dressing to confirm its safety and efficacy for the treatment of split-thickness skin donor sites. The safety test was performed using a patch model and no evidence of marked and severe cutaneous reactions was found. The efficacy test of the bilayered wound dressing was conducted on 23 patients with 30 split-thickness skin graft donor sites to evaluate healing time, pain score, skin barrier function, and systemic reaction in comparison to Bactigras. We found that the healing time of donor site wounds treated with the bilayered wound dressing (11 ± 6 days) was significantly faster than those treated with Bactigras (14 ± 6 days) (p = 10−6). The wound sites treated with the bilayered wound dressing showed significantly less pain and more rapid skin functional barrier recovery than those treated with Bactigras (p = 10−5). Therefore, these results confirmed the clinical safety and efficacy of the bilayered wound dressing for the treatment of split-thickness skin graft donor sites.

Highlights

Split-thickness skin grafting is a surgical procedure that harvests the healthy skin and uses it to cover the wound to activate wound healing
The bilayered wound dressing is composed of a wax-coated silk fibroin woven fabric as a nonadhesive layer and a sponge made of sericin and glutaraldehyde-cross-linked silk fibroin/gelatin as a bioactive layer
From the peel test on the full-thickness wound of porcine skin, we found that the bilayered wound dressing could be removed from the wound much more than the Bactigras

Summary

Introduction

Split-thickness skin grafting is a surgical procedure that harvests the healthy skin and uses it to cover the wound to activate wound healing. The in vitro analysis showed that the wax-coated silk fibroin fabric had improved mechanical properties and adhered less to the wound, while the spongy bioactive layers had a homogeneous porous structure and controllable biodegradation and supported the attachment and proliferation of L929 mouse fibroblasts We tested this bilayered wound dressing in vivo and proved that it could promote healing of the full-thickness wounds in a rat model by the induction of epithelialization and collagen formation [4]. The efficacy test of the bilayered wound dressing was conducted on 23 patients with 30 split-thickness skin graft donor sites to evaluate healing time, pain score, skin barrier function (transepidermal water loss), wound infection, systemic adverse reactions, morphology of epithelial cells, and blood biochemistry. The results from this study could support the use of bilayered wound dressings for split-thickness skin donor site or any partial thickness wound treatments in the future

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