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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.

Hasatsri S, Angspatt A, Aramwit P - Evid Based Complement Alternat Med (2015)

Bottom Line: And it showed relevant characteristics and accelerated the healing of full-thickness wounds in a rat model.The safety test was performed using a patch model and no evidence of marked and severe cutaneous reactions was found.Therefore, these results confirmed the clinical safety and efficacy of the bilayered wound dressing for the treatment of split-thickness skin graft donor sites.

View Article: PubMed Central - PubMed

Affiliation: Bioactive Resources for Innovative Clinical Applications Research Unit and Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn University, Phayathai Road, Pathumwan, Bangkok 10330, Thailand.

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.

No MeSH data available.


Median pain score of donor site wound treated with Bactigras and bilayered wound dressing. (- -●- -) Bactigras, (- -○- -) bilayered wound dressing.  ∗Significant difference (p < 0.001 versus Bactigras), calculated by a Wilcoxon signed rank test.
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fig2: Median pain score of donor site wound treated with Bactigras and bilayered wound dressing. (- -●- -) Bactigras, (- -○- -) bilayered wound dressing.  ∗Significant difference (p < 0.001 versus Bactigras), calculated by a Wilcoxon signed rank test.

Mentions: Table 3 presents the time that the split-thickness skin graft donor sites treated with Bactigras or the bilayered wound dressing had completely healed. 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). Figure 1(d) shows the appearance of the healed donor site. Epithelium regeneration was observed on the site treated with the bilayered wound dressing, as compared to the site treated with Bactigras. Figure 2 shows pain scores of donor site wounds treated with Bactigras or the bilayered wound dressing for 1–5 days postoperatively. Pain scores of the wounds treated with both dressings were gradually reduced from day 1 to day 5. On each day, pain scores of wounds treated with the bilayered wound dressing were significantly lower than those of wounds treated with Bactigras.


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.

Hasatsri S, Angspatt A, Aramwit P - Evid Based Complement Alternat Med (2015)

Median pain score of donor site wound treated with Bactigras and bilayered wound dressing. (- -●- -) Bactigras, (- -○- -) bilayered wound dressing.  ∗Significant difference (p < 0.001 versus Bactigras), calculated by a Wilcoxon signed rank test.
© Copyright Policy - open-access
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC4499634&req=5

fig2: Median pain score of donor site wound treated with Bactigras and bilayered wound dressing. (- -●- -) Bactigras, (- -○- -) bilayered wound dressing.  ∗Significant difference (p < 0.001 versus Bactigras), calculated by a Wilcoxon signed rank test.
Mentions: Table 3 presents the time that the split-thickness skin graft donor sites treated with Bactigras or the bilayered wound dressing had completely healed. 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). Figure 1(d) shows the appearance of the healed donor site. Epithelium regeneration was observed on the site treated with the bilayered wound dressing, as compared to the site treated with Bactigras. Figure 2 shows pain scores of donor site wounds treated with Bactigras or the bilayered wound dressing for 1–5 days postoperatively. Pain scores of the wounds treated with both dressings were gradually reduced from day 1 to day 5. On each day, pain scores of wounds treated with the bilayered wound dressing were significantly lower than those of wounds treated with Bactigras.

Bottom Line: And it showed relevant characteristics and accelerated the healing of full-thickness wounds in a rat model.The safety test was performed using a patch model and no evidence of marked and severe cutaneous reactions was found.Therefore, these results confirmed the clinical safety and efficacy of the bilayered wound dressing for the treatment of split-thickness skin graft donor sites.

View Article: PubMed Central - PubMed

Affiliation: Bioactive Resources for Innovative Clinical Applications Research Unit and Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn University, Phayathai Road, Pathumwan, Bangkok 10330, Thailand.

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.

No MeSH data available.