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细菌纤维素敷料与凡士林纱布用于浅Ⅱ度烧伤创面及皮肤移植供区的疗效评估:一项双中心随机对照临床研究。

Evaluation of Bacterial Cellulose Dressing versus Vaseline Gauze in Partial Thickness Burn Wounds and Skin Graft Donor Sites: A Two-Center Randomized Controlled Clinical Study.

作者信息

Pan Xuanliang, Han Chunmao, Chen Guoxian, Fan Youfen

机构信息

Department of Burns and Wound Repair, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou 310009, Zhejiang Province, China.

Burn Care Center, Hwa Mei Hospital, University of Chinese Academy of Sciences, Ningbo, China.

出版信息

Evid Based Complement Alternat Med. 2022 May 18;2022:5217617. doi: 10.1155/2022/5217617. eCollection 2022.

Abstract

OBJECTIVE

Bacterial cellulose (BC) dressing, which can maintain a moist environment and prevent the invasion of pathogens, has become a competitive dressing material for burn wound treatment. This study was conducted to evaluate the treatment efficacy of a novel China-made BC dressing for the treatment of second-degree burn wounds and skin graft donor sites.

METHODS

212 patients with second-degree burn wounds or skin graft donor sites were enrolled from two research centers. They were randomly assigned to the BC dressing group (study group) or the Vaseline gauze (VG) dressing group (control group). Wound conditions were assessed before and after treatment. Dressings were changed according to the condition of the wound bed. Healing rate and healing time were recorded as primary endpoints to evaluate the efficacy of BC dressing against VG dressing. Erythema, swelling, exudation, bleeding, subeschar purulence, and pain were assessed as secondary endpoints.

RESULTS

207 participants completed the trial and their wounds all healed within 28 days. The average healing times for superficial and deep secondary burn wounds and skin graft donor sites in the BC group were 8.12, 15.77, and 10.55 days, respectively. In the VG group, the average healing times for superficial and deep secondary burn wounds and skin graft donor sites were 9.30, 15.27, and 11.19 days, respectively. The healing time of superficial burn wounds in the BC group was statistically shorter than that in the VG group. There was no difference in the frequency of dressing changing between two groups. The BC dressing showed equal efficacy with the VG dressing at all secondary endpoints.

CONCLUSION

The novel BC dressing could be used for the management of second-degree burn wounds and skin graft donor sites. With a shorter healing time in superficial secondary burn wound than that of the VG dressing, the BC dressing showed noninferiority in the treatment of superficial and deep secondary burn wounds and skin graft donor sites versus the VG dressing. This study is registered with the Chinese Clinical Trial Registry (registry number: ChiCTR1800014377 (http://www.chictr.org.cn)).

摘要

目的

细菌纤维素(BC)敷料能够维持湿润环境并防止病原体入侵,已成为烧伤创面治疗中有竞争力的敷料材料。本研究旨在评估一种新型国产BC敷料治疗二度烧伤创面及皮肤移植供区的疗效。

方法

从两个研究中心招募212例二度烧伤创面或皮肤移植供区患者。他们被随机分配至BC敷料组(研究组)或凡士林纱布(VG)敷料组(对照组)。治疗前后评估创面情况。根据创面床情况更换敷料。记录愈合率和愈合时间作为主要终点,以评估BC敷料相对于VG敷料的疗效。评估红斑、肿胀、渗出、出血、痂下积脓和疼痛作为次要终点。

结果

207名参与者完成试验,其创面均在28天内愈合。BC组浅二度和深二度烧伤创面及皮肤移植供区的平均愈合时间分别为8.12天、15.77天和10.55天。在VG组中,浅二度和深二度烧伤创面及皮肤移植供区的平均愈合时间分别为9.30天、15.27天和11.19天。BC组浅二度烧伤创面的愈合时间在统计学上短于VG组。两组换药频率无差异。在所有次要终点上,BC敷料与VG敷料显示出同等疗效。

结论

新型BC敷料可用于二度烧伤创面及皮肤移植供区的处理。BC敷料在浅二度烧伤创面的愈合时间比VG敷料短,在治疗浅二度和深二度烧伤创面及皮肤移植供区方面相对于VG敷料显示出非劣效性。本研究已在中国临床试验注册中心注册(注册号:ChiCTR1800014377 (http://www.chictr.org.cn))。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ae31/9155909/50784feb8120/ECAM2022-5217617.001.jpg

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