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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.


(a) Thigh area before surgery, (b) split-thickness skin graft donor site after the skin was taken, (c) split-thickness skin graft donor site treated with Bactigras and bilayered wound dressing, and (d) healed split-thickness skin graft donor site (postdonor site healing day 1 for the site treated with bilayered wound dressing and postdonor site healing day 0 for the site treated with Bactigras).
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Related In: Results  -  Collection


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fig1: (a) Thigh area before surgery, (b) split-thickness skin graft donor site after the skin was taken, (c) split-thickness skin graft donor site treated with Bactigras and bilayered wound dressing, and (d) healed split-thickness skin graft donor site (postdonor site healing day 1 for the site treated with bilayered wound dressing and postdonor site healing day 0 for the site treated with Bactigras).

Mentions: The split-thickness skin graft donor site was divided into a cephalad half and a caudal half of equal size, and each site was randomized to receive the bilayered wound dressing or Bactigras (Figure 1). Then, both dressings were covered with gauze pads and elastic bandages. The dressings were not changed, except when they were fully soaked with exudate, when they had peeled off, or when there was any sign of infection.


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)

(a) Thigh area before surgery, (b) split-thickness skin graft donor site after the skin was taken, (c) split-thickness skin graft donor site treated with Bactigras and bilayered wound dressing, and (d) healed split-thickness skin graft donor site (postdonor site healing day 1 for the site treated with bilayered wound dressing and postdonor site healing day 0 for the site treated with Bactigras).
© Copyright Policy - open-access
Related In: Results  -  Collection

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

fig1: (a) Thigh area before surgery, (b) split-thickness skin graft donor site after the skin was taken, (c) split-thickness skin graft donor site treated with Bactigras and bilayered wound dressing, and (d) healed split-thickness skin graft donor site (postdonor site healing day 1 for the site treated with bilayered wound dressing and postdonor site healing day 0 for the site treated with Bactigras).
Mentions: The split-thickness skin graft donor site was divided into a cephalad half and a caudal half of equal size, and each site was randomized to receive the bilayered wound dressing or Bactigras (Figure 1). Then, both dressings were covered with gauze pads and elastic bandages. The dressings were not changed, except when they were fully soaked with exudate, when they had peeled off, or when there was any sign of infection.

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.