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胶原蛋白基质敷料应用于糖尿病神经性足溃疡:一项随机对照试验。

Application of a collagen matrix dressing on a neuropathic diabetic foot ulcer: a randomised control trial.

作者信息

Djavid Gholamreza Esmaeeli, Tabaie Seyed Mehdi, Tajali Siamak Bashardoust, Totounchi Mehrangiz, Farhoud Amirreza, Fateh Mohsen, Ghafghazi Mahmoud, Koosha Mojtaba, Taghizadeh Solmaz

机构信息

1 Department of Photo Healing and Regeneration, Medical Laser Research Center, Yara Institute, Academic Center for Education, Culture and Research (ACECR), Tehran, Iran.

2 Department of Physiotherapy, School of Rehabilitation, Tehran University of Medical Sciences (TUMS), Tehran, Iran.

出版信息

J Wound Care. 2020 Mar 2;29(Sup3):S13-S18. doi: 10.12968/jowc.2020.29.Sup3.S13.

Abstract

OBJECTIVE

Diabetic foot ulcers (DFU) are often hard-to-heal, despite standard care. With such a complicated healing process, any advanced wound care to aid healing is recommended. Chitosan/collagen composite hydrogel materials have the potential to promote the regenerative process. In this study, the efficacy of a new collagen matrix dressing including chitosan/collagen hydrogel was compared with a standard dressing of saline-moistened gauze for wound healing in patients with a hard-to-heal neuropathic DFU.

METHOD

This is an open labelled, randomised clinical trial. After conventional therapy consisting of debridement, infection control and offloading, patients were randomly allocated to receive either a collagen matrix dressing (the study group, receiving Tebaderm manufacturer) or a saline-moistened gauze dressing (control group) for wound care. The reduction in DFU size and the number of patients with complete healing were measured throughout the treatment and in follow-up.

RESULTS

A total of 61 patients with a neuropathic DFU were recruited. Average percentage reduction in DFU size at four weeks was greater in the study group compared with the control group (54.5% versus 38.8%, respectively). Rate of complete healing rate at 20-weeks' follow-up was significantly better in the study group than the control group (60% versus 35.5%, respectively).

CONCLUSION

The collagen matrix dressing used in this study accelerated the healing process of patients with a hard-to-heal DFU. Further research may suggest the used of this dressing to shorten the length of time to achieve complete healing.

摘要

目的

尽管采用了标准护理,但糖尿病足溃疡(DFU)往往难以愈合。鉴于愈合过程如此复杂,推荐采用任何先进的伤口护理方法来促进愈合。壳聚糖/胶原蛋白复合水凝胶材料有促进再生过程的潜力。在本研究中,将一种含壳聚糖/胶原蛋白水凝胶的新型胶原蛋白基质敷料与用于难愈合神经性DFU患者伤口愈合的生理盐水湿润纱布标准敷料的疗效进行了比较。

方法

这是一项开放标签的随机临床试验。在进行包括清创、控制感染和减轻压力的常规治疗后,患者被随机分配接受胶原蛋白基质敷料(研究组,使用Tebaderm产品)或生理盐水湿润纱布敷料(对照组)进行伤口护理。在整个治疗过程及随访期间,测量DFU大小的减小情况以及完全愈合的患者数量。

结果

共招募了61例神经性DFU患者。研究组在四周时DFU大小的平均减小百分比高于对照组(分别为54.5%和38.8%)。在20周随访时,研究组的完全愈合率明显优于对照组(分别为60%和35.5%)。

结论

本研究中使用的胶原蛋白基质敷料加速了难愈合DFU患者的愈合过程。进一步的研究可能会表明使用这种敷料可缩短实现完全愈合的时间。

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