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评估脱细胞可流动基质与湿性敷料相比治疗糖尿病足溃疡患者的疗效:一项随机临床试验。

To evaluate the efficacy of an acellular Flowable matrix in comparison with a wet dressing for the treatment of patients with diabetic foot ulcers: a randomized clinical trial.

作者信息

Campitiello F, Mancone M, Della Corte A, Guerniero R, Canonico S

机构信息

Department of Medical, Surgical, Neurologic, Metabolic and Aging Sciences, University of Campania "Luigi Vanvitelli", Piazza Miraglia, 2, 80138, Naples, Italy.

出版信息

Updates Surg. 2017 Dec;69(4):523-529. doi: 10.1007/s13304-017-0461-9. Epub 2017 May 11.

Abstract

The authors aimed to evaluate the efficacy of an advanced wound matrix (Integra Flowable Wound Matrix, Integra LifeScience Corp, Plainsboro, NJ, USA) for treating wounds with irregular geometries versus a wet dressing in patients with diabetic foot ulcers. Sixty patients with diabetic foot ulcers (Grades 3 Wagner) were included in this randomized clinical trial. The study was conducted in the General Surgery Unit and Geriatric of the Second University of Naples, Italy, in the last 12 months. Forty-six cases of diabetic foot ulcers were equally and randomly divided into control and test groups. The first group treated with Integra Flowable Wound Matrix, while the control group with a wet dressing. Both groups were evaluated once a week for 6 weeks to value the degree of epithelialization and granulation tissue of the wound. The complete healing rate in the whole study population was 69.56% (Integra Flowable Wound Matrix group, 86.95%, control group, 52.17%; p = 0.001). Amputation and rehospitalization rates were higher in the control group compared to the first group, therefore, the difference was statistically significant (p = 0.0019; p = 0.028, respectively). The Integra Flowable Wound Matrix, was significantly superior, compared to the wet dressing, by promoting the complete healing of diabetic foot ulcers. Ease of use, absence of adverse effects, and a facilitated wound healing process are among the properties of the matrix. These characteristics make it appropriate in the management of diabetic foot ulcers. Additional research will shed more light on the promising advantages of this material in healing diabetic foot ulcers.

摘要

作者旨在评估一种先进伤口基质(可流动型Integra伤口基质,美国新泽西州普林斯顿市Integra生命科学公司)治疗不规则几何形状伤口的疗效,并与糖尿病足溃疡患者使用的湿性敷料进行比较。60例糖尿病足溃疡(Wagner 3级)患者纳入了这项随机临床试验。该研究在意大利那不勒斯第二大学普通外科和老年病科进行,为期12个月。46例糖尿病足溃疡患者被平均随机分为对照组和试验组。第一组使用可流动型Integra伤口基质治疗,而对照组使用湿性敷料。两组每周评估一次,共6周,以评估伤口的上皮化程度和肉芽组织情况。整个研究人群的完全愈合率为69.56%(可流动型Integra伤口基质组为86.95%,对照组为52.17%;p = 0.001)。对照组的截肢率和再次住院率高于第一组,因此,差异具有统计学意义(分别为p = 0.0019;p = 0.028)。与湿性敷料相比,可流动型Integra伤口基质通过促进糖尿病足溃疡的完全愈合,具有显著优势。该基质具有使用方便、无不良反应以及促进伤口愈合过程等特性。这些特点使其适用于糖尿病足溃疡的治疗。更多研究将进一步揭示这种材料在治疗糖尿病足溃疡方面的潜在优势。

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