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丝胶释放型生物活性创伤敷料治疗断层皮片供皮区的临床潜力。

Clinical potential of a silk sericin-releasing bioactive wound dressing for the treatment of split-thickness skin graft donor sites.

机构信息

Bioactive Resources for Innovative Clinical Applications Research Unit, Chulalongkorn University, Bangkok, Thailand.

出版信息

Pharm Res. 2014 Jan;31(1):104-16. doi: 10.1007/s11095-013-1136-y. Epub 2013 Jul 31.

Abstract

PURPOSE

An ethyl alcohol-precipitated silk sericin/PVA scaffold that controlled the release of silk sericin was previously developed and applied for the treatment of full-thickness wounds in rats and demonstrated efficient healing. In this study, we aimed to further evaluate the clinical potential of this scaffold, hereafter called "silk sericin-releasing wound dressing", for the treatment of split-thickness skin graft donor sites by comparison with the clinically available wound dressing known as "Bactigras®".

METHODS

In vitro characterization and in vivo evaluation for safety of the wound dressings were performed. A clinical trial of the wound dressings was conducted according to standard protocols.

RESULTS

The sericin released from the wound dressing was not toxic to HaCat human keratinocytes. A peel test indicated that the silk sericin-releasing wound dressing was less adhesive than Bactigras®, potentially reducing trauma and the risk of repeated injury upon removal. There was no evidence of skin irritation upon treatment with either wound dressing. When tested in patients with split-thickness skin graft donor sites, the wounds treated with the silk sericin-releasing wound dressing exhibited complete healing at 12 ± 5.0 days, whereas those treated with Bactigras® were completely healed at 14 ± 5.2 days (p = 1.99 × 10(-4)). In addition, treatment with the silk sericin-releasing wound dressing significantly reduced pain compared with Bactigras® particularly during the first 4 postoperative days (p = 2.70 × 10(-5) on day 1).

CONCLUSION

We introduce this novel silk sericin-releasing wound dressing as an alternative treatment for split-thickness skin graft donor sites.

摘要

目的

先前开发了一种乙醇沉淀丝胶/PVA 支架,可控制丝胶的释放,用于治疗大鼠全层创面,并证明其具有高效的愈合效果。在本研究中,我们旨在通过与临床可用的创面敷料“Bactigras®”进行比较,进一步评估该支架(称为“丝胶释放创面敷料”)在治疗刃厚皮片供皮区创面的临床潜力。

方法

对创面敷料进行体外特性表征和体内安全性评估。按照标准方案进行了创面敷料的临床试验。

结果

从创面敷料中释放的丝胶对 HaCat 人角质形成细胞没有毒性。去皮试验表明,丝胶释放创面敷料的粘性低于 Bactigras®,可能减少在去除敷料时的创伤和重复损伤的风险。两种创面敷料治疗均未见皮肤刺激。在接受刃厚皮片供皮区创面的患者中进行测试时,使用丝胶释放创面敷料治疗的创面在 12±5.0 天完全愈合,而使用 Bactigras®治疗的创面在 14±5.2 天完全愈合(p=1.99×10(-4))。此外,与 Bactigras®相比,丝胶释放创面敷料治疗显著减轻了疼痛,尤其是在术后第 4 天(第 1 天 p=2.70×10(-5))。

结论

我们引入这种新型的丝胶释放创面敷料作为治疗刃厚皮片供皮区创面的替代方法。

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