A Parallel Randomized Clinical Trial for Comparison of Two Methods of Maggot Therapy, Free-Range Larvae and Larval-bag, in Diabetic Ulcer (Wagner 2).

IF 1.5 4区 医学 Q3 DERMATOLOGY
Omid Dehghan, Seyed Mehdi Tabaie, Javad Rafinejad, Mehrangiz Toutounchi, Amir Tiyuri, Sahar Azarmi, Gholamreza Esmaeeli Djavid, Kamran Akbarzadeh
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Abstract

In the present study, the efficiency of two formulations of maggot therapy: free-range larvae on the wounds and larvae in a special bag (larval-bag), was compared for healing diabetic ulcers with Wagner 2 diabetic ulcer. This study was conducted as a parallel randomized clinical trial. Out of 281 patients with Wagner grade 2 diabetic ulcers referred to the wound clinic, 54 patients who met the inclusion criteria were randomly assigned to intervention groups. The disinfected larvae of Lucilia sericata were put on the wounds with 2 methods, free-range larvae and larval-bag. Follow up was done at every 48 h interval until the full appearance of granulated tissues. The main measures were wound bed preparation, removing of necrotic tissues, appearing of granulated tissues, and removing of bacterial infections in the wounds. Statistical analysis based on the Kaplan-Meier curve and the Wilcoxon (Breslow) test showed a significant reduction in wound healing time by using free-range larvae in comparison with larval-bag (P = .03). The median time to debridement was 4 days in the free-range larval group (95% confidence interval: 3-9 days) while it was 9 days in the larval-bag group (95% confidence interval: 5-16 days). Debridement rate (proportion of removed necrotic tissue surfaces) at any time in the free-ranged larvae group was 1.78 times that of the bagged larvae group (95% confidence interval 1.01-3.15, P = .036). There was no significant difference between free-range larval use and larval-bag in the acceptability of maggot therapy by patients (P = .48). It can be concluded that both of two formulations of the larval therapy (free-range larvae and larval-bag) could be recommended for cleaning out and bed preparation of diabetic ulcers. However, using free-range larvae is hardly recommended on the wounds which are eligible to use.

比较两种蛆虫疗法--散养幼虫和幼虫袋--治疗糖尿病溃疡的平行随机临床试验(Wagner 2)。
在本研究中,比较了两种蛆虫疗法配方(伤口上散养的幼虫和装在特制袋子(幼虫袋)中的幼虫)对瓦格纳 2 型糖尿病溃疡愈合的效果。该研究以平行随机临床试验的形式进行。在转诊到伤口诊所的 281 名瓦格纳 2 级糖尿病溃疡患者中,54 名符合纳入标准的患者被随机分配到干预组。将消毒后的绢毛琉璃苣幼虫放在伤口上,分为散养幼虫和幼虫袋两种方法。每隔 48 小时进行一次随访,直至肉芽组织完全出现。主要措施包括伤口床的准备、坏死组织的清除、肉芽组织的出现以及伤口细菌感染的清除。基于 Kaplan-Meier 曲线和 Wilcoxon (Breslow) 检验的统计分析显示,与袋装幼虫相比,散养幼虫能显著缩短伤口愈合时间(P = .03)。散养幼虫组的清创时间中位数为 4 天(95% 置信区间:3-9 天),而幼虫袋组的清创时间中位数为 9 天(95% 置信区间:5-16 天)。放养幼虫组在任何时间的清创率(清除坏死组织表面的比例)都是袋装幼虫组的 1.78 倍(95% 置信区间:1.01-3.15,P = .036)。在患者对蛆疗法的接受程度上,放养幼虫组和袋装幼虫组没有明显差异(P = .48)。可以得出结论,两种幼虫疗法配方(散养幼虫和幼虫袋)都可推荐用于糖尿病溃疡的清理和床铺准备。不过,在符合使用条件的伤口上,几乎不建议使用散养幼虫。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
4.60
自引率
17.60%
发文量
95
审稿时长
>12 weeks
期刊介绍: The International Journal of Lower Extremity Wounds (IJLEW) is a quarterly, peer-reviewed journal publishing original research, reviews of evidence-based diagnostic techniques and methods, disease and patient management, and surgical and medical therapeutics for lower extremity wounds such as burns, stomas, ulcers, fistulas, and traumatic wounds. IJLEW also offers evaluations of assessment and monitoring tools, dressings, gels, cleansers, pressure management, footwear/orthotics, casting, and bioengineered skin. This journal is a member of the Committee on Publication Ethics (COPE).
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