Efficacy and safety of chitosan wound dressing for deep second-degree burn: a prospective, single-blind, randomized controlled trial

doi:10.3969/j.issn.2095-4344.2017.14.015

Abstract

Abstract:

BACKGROUND: Chitosan wound dressing has been extensively used in the treatment of wounds and burns, not only because of its bacteriastasis, hemostasis and promoting the wound healing, but also its good biocompatibility, biodegradability and biological functions.
OBJECTIVE: To evaluate the efficacy and safety of chitosan wound dressing for deep second-degree burn, thereby providing clinical basis for its registration.
METHODS: Sixty patients with deep second-degree burn were randomly allotted to two groups, and then subjected to the external application of chitosan wound dressing (experimental group) or chitosan biomedical dressing (control group), respectively. Then, the therapeutic efficacy was evaluated through healing time, recovering rate and pain scores, and the safety was evaluated through the incidence of adverse reactions and laboratory indexes before and after treatment.
RESULTS AND CONCLUSION: There were no significant differences in the wound healing time [(21.23±6.84) days vs. (23.77±4.26) days], recovery rate and pain scores between the experimental and control groups at 14, 21 and 28 days after treatment (P > 0.05). The blood routine, liver function and kidney function indexes before and after treatment did not differ significantly between groups. Additionally, neither adverse nor severe adverse events occurred in the two groups. These results indicate that the therapeutic efficacy and safety of the chitosan wound dressing are equivalent to the control product in the treatment of deep second-degree burn.

中国组织工程研究杂志出版内容重点：生物材料；骨生物材料; 口腔生物材料; 纳米材料; 缓释材料; 材料相容性；组织工程

Key words: Chitosan, Biological Dressings, Burns, Tissue Engineering

CLC Number:

R318

Liu Lin-na, Li Xue-yong, Zhao Cong-ying, Guan Bo, Wu Xiao-chun, Zhang Tian, Li Shi-cao. Efficacy and safety of chitosan wound dressing for deep second-degree burn: a prospective, single-blind, randomized controlled trial[J]. Chinese Journal of Tissue Engineering Research, 2017, 21(14): 2222-2226.

Figures/Tables 6

References

[1]黎鳌.烧伤治疗学[M].2版.北京:人民卫生出版社,1997:5.

[2]袁丹波.壳聚糖抗菌生物医用膜在烧伤创面中的临床应用[J].微生物学免疫学进展,2012,40(1):35-37.

[3]朱香利.壳聚糖生物医用材料的应用[J].中外医疗, 2013,32(14): 12-14.

[4]杨震.壳聚糖及其衍生物在创伤修复领域的应用进展[J].西部医学,2013,25(2):314-316.

[5]蔡良良,吕国忠,陈敬华,等.光交联壳聚糖水凝胶膜治疗深Ⅱ度烧伤创面的临床研究[J].中华损伤与修复杂志(电子版), 2010,5(1): 27-29.

[6]黄佩芸.壳聚糖创面修复凝胶在Ⅱ期、Ⅲ期压疮护理中的疗效观察[J].右江医学,2013,41(6):934-935.

[7]吴燕珍.壳聚糖衍生物酰氨基葡萄糖在烧伤早期的应用[J].当代护士旬刊,2012,10(10):35-36.

[8]李清,杨卫国,陆原.壳聚糖医用膜用于皮肤轻度烧、烫伤治疗的疗效及安全性观察[J].中国医学创新,2012,9(36):38-39.

[9]张晓曼.羧甲基壳聚糖湿性敷料对手术切口愈合影响的研究[J].成都医学院学报,2012,7(2):276-278.

[10]刘琳娜,李学拥,吴晓春,等.银离子抗菌敷料用于Ⅱ度烧伤创面的疗效和安全性[J].实用药物与临床,2013,16(10):922-924.

[11]龚振华,姚建,季建峰,等.银离子敷料联合水凝胶对度烧伤创面愈合的作用[J]中国组织工程研究与临床康复,2009,13(42):8373-8376.

[12]赵遵江,薛忠信,章荣涛,等.生物流体膜与湿润烧伤膏对二度烧伤创面疗效的对比[J].安徽医学,2005,26(3):222-223.

[13]唐菲,朱毅.六味芦荟膏对感染性烧、烫伤创面的促愈合作用研究[J].中国药房,2006,17(10):733-736.

[14]吴晓明,孙艳军,孙奎,等.德莫林联合纳米银医用抗菌敷料治疗老年Ⅱ度烧伤创面的疗效[J].中国老年学杂志,2013,33(6):1291-1292.

[15]朱东来,武凤莲,王连英,等.重组人酸性成纤维细胞生长因子与纳米银敷料联合治疗深Ⅱ度烧伤创面的临床观察[J].中国美容医学,2013,22(18):1840-1842.

[16]蔡少甫,余昌龙.壳聚糖联合纳米银医用抗菌敷料治疗老年Ⅱ度烧伤创面的疗效观察[J].中国社区医师,2016,32(6):78-79.

[17]刘继松,方勇,姚敏,等.重组人粒细胞巨噬细胞集落刺激因子凝胶剂对深Ⅱ度烧伤创面溶痂及愈合影响的临床研究[J].中国修复重建外科杂志,2011,25(9):1059-1062.

[18]王配合,杨建民,张轶,等.液超妥与痊愈妥复合敷料治疗Ⅱ度烧伤创面的效果观察[J].临床误诊误治,2011,24(6):17-18.

[19]张群,阿不都拉,艾赛提.复方薰衣草油膏治疗Ⅱ度烧伤创面临床对比观察[J].医学理论与实践,2011,24(17):2039-2040.

[20]温春泉,赵筱卓,张国安.外用重组人粒细胞巨噬细胞集落刺激因子凝胶治疗深Ⅱ度烧伤创面临床疗效观察[J].中华损伤与修复杂志(电子版),2016,11(3):215-218.

[21]孙羽飞,李翔,徐文举.纳米银敷料对深Ⅱ度烧伤创面修复作用的观察[J]. 临床医药文献杂志,2016,3(7):1231-1232

[22]王志刚,刘韬,郝朝辉,等.复春散1号与 2 号联合治疗面部深Ⅱ度烧伤的疗效观察[J].内蒙古中医药,2016,35(4):30.

[23]王斌,罗旭,唐从容,等.磺胺嘧啶银霜联合重组人粒细胞巨噬细胞刺激因子凝胶治疗深Ⅱ度烧伤创面的疗效评价[J].医药导报, 2015,34(12):1588-1590.

[24]张永生.纳米银外用抗菌凝胶联合臭氧治疗深Ⅱ度烧伤创面90例[J].中国药业,2015,24(3):78-79.

[25]李林.胰岛素联合重组人酸性成纤维细胞生长因子对深Ⅱ度烧伤创面愈合的效果观察[J].山东医药,2014,54(45):75-76.

[26]鲜华,尤婷婷,谭杜勋,等.壳聚糖创面修复膜凝胶门诊治疗Ⅱ度烧伤的临床疗效观察[J].重庆医学,2014,43(36):4959-4961

[27]李恒,彭辉.Ⅱ度烧伤创面4种外用药物使用及临床效果比较[J].中国冶金工业医学杂志,2015,32(2):159-160.

[28]王勇,王光华.湿润烧伤膏联合重组人表皮生长因子凝胶在Ⅱ度烧伤中的临床应用[J].河南外科学杂志,2015,21(1):91-92.

[29]高娅,崔正军,史迅,等.生物流体敷料对Ⅱ度烧伤创面的疗效观察[J].中国美容医学, 2015,24(4):1-3.

[30]柴家科,孙永华,夏照帆,等.酸性成纤维细胞生长因子治疗深Ⅱ度烧伤的多中心随机对照临床试验[J].中国药师,2015,18(4):589-591.

[31]王强,刘筱雯,吕仁荣,等.生物敷料A对比银离子水胶体油纱修复面部Ⅱ度烧伤[J].中国组织工程研究,2015,19(10):2573-2577.

[32]Wang L,Hao C,Zhou B,et al.Application of Heparinized Selective Acellular Sheepskin in Wound-healing Promotion of Deep Second-degree Burns. Wounds. 2016.pii: WNDS20160929-3.[Epub ahead of print]

[33]Esteban-Vives R,Choi MS,Young MT,et al.Second-degree burns with six etiologies treated with autologous noncultured cell-spray grafting.Burns.2016;42(7):e99-e106.

[34]Najmi M,Vahdat Shariatpanahi Z,Tolouei M,et al.Effect of oral olive oil on healing of 10-20% total body surface area burn wounds in hospitalized patients.Burns. 2015;41(3):493-496.

[35]Cho YS,Choi YH,Yoon C,et al.Factors affecting the depth of burns occurring in medical institutions.Burns. 2015;41(3): 604-608.

[36]Yim H,Yang HT,Cho YS,et al.A clinical trial designed to evaluate the safety and effectiveness of a thermosensitive hydrogel-type cultured epidermal allograft for deep second-degree burns.Burns.2014;40(8):1642-1649.

[37]Ouyang J,Chen YC,Luo GX,et al.A randomized and controlled multicenter prospective study of the Chinese medicinal compound Fufang Xuelian Burn Ointment for the treatment of superficial and deep second-degree burn wounds. Cell Biochem Biophys.2014;69(3):467-474.