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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 transepidermal water loss (TEWL) of healed donor site treated with Bactigras and bilayered wound dressing. (- -●- -) Bactigras, (- -○- -) bilayered wound dressing. TEWL index = TEWL of postdonor site healing day A/TEWL of adjacent normal skin day A.  ∗Significant difference (p < 0.001 versus Bactigras), calculated by a Wilcoxon signed rank test.
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fig3: Median transepidermal water loss (TEWL) of healed donor site treated with Bactigras and bilayered wound dressing. (- -●- -) Bactigras, (- -○- -) bilayered wound dressing. TEWL index = TEWL of postdonor site healing day A/TEWL of adjacent normal skin day A.  ∗Significant difference (p < 0.001 versus Bactigras), calculated by a Wilcoxon signed rank test.

Mentions: Figure 3 shows the median TEWL of the healed donor site treated with Bactigras or the bilayered wound dressing. Median TEWL of the wounds treated with Bactigras and the bilayered wound dressing on the day of donor site healing (day 0) were 2.8 ± 0.8 and 2.3 ± 0.9 times, respectively, higher than that of adjacent normal skin. Additionally, the median TEWL on donor site after 150 days was 1.22 ± 0.43 and 1.09 ± 0.23 times significantly higher than adjacent normal skin for Bactigras (p = 10−6) and the bilayered wound dressing (p = 10−6), respectively. As with the postdonor site healing days, the donor site wounds treated with the bilayered wound dressing showed a significantly lower TEWL index than those treated with Bactigras (p = 10−5), implying a faster TEWL recovery of the wounds treated with the bilayered wound dressing.


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 transepidermal water loss (TEWL) of healed donor site treated with Bactigras and bilayered wound dressing. (- -●- -) Bactigras, (- -○- -) bilayered wound dressing. TEWL index = TEWL of postdonor site healing day A/TEWL of adjacent normal skin day A.  ∗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

fig3: Median transepidermal water loss (TEWL) of healed donor site treated with Bactigras and bilayered wound dressing. (- -●- -) Bactigras, (- -○- -) bilayered wound dressing. TEWL index = TEWL of postdonor site healing day A/TEWL of adjacent normal skin day A.  ∗Significant difference (p < 0.001 versus Bactigras), calculated by a Wilcoxon signed rank test.
Mentions: Figure 3 shows the median TEWL of the healed donor site treated with Bactigras or the bilayered wound dressing. Median TEWL of the wounds treated with Bactigras and the bilayered wound dressing on the day of donor site healing (day 0) were 2.8 ± 0.8 and 2.3 ± 0.9 times, respectively, higher than that of adjacent normal skin. Additionally, the median TEWL on donor site after 150 days was 1.22 ± 0.43 and 1.09 ± 0.23 times significantly higher than adjacent normal skin for Bactigras (p = 10−6) and the bilayered wound dressing (p = 10−6), respectively. As with the postdonor site healing days, the donor site wounds treated with the bilayered wound dressing showed a significantly lower TEWL index than those treated with Bactigras (p = 10−5), implying a faster TEWL recovery of the wounds treated with the bilayered wound dressing.

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.