即用型微米化人脱细胞真皮基质加速糖尿病足溃疡愈合：一项前瞻性随机初步研究。
Ready-to-Use Micronized Human Acellular Dermal Matrix to Accelerate Wound Healing in Diabetic Foot Ulcers: A Prospective Randomized Pilot Study.
机构信息
At the Ajou University School of Medicine, Suwon, Republic of Korea, Hyung Min Hahn, MD, is Assistant Professor; Dong Hwan Lee, MD, is a Resident; Il Jae Lee, MD, PhD, is Associate Professor, Department of Plastic and Reconstructive Surgery. Acknowledgments: The authors thank Editage ( www.editage.co.kr ) for English language editing. This research was supported by a Korea Health Industry Development Institute grant to Ajou University Medical Center. The authors have disclosed no other financial relationships related to this article. Submitted May 28, 2020; accepted in revised form September 3, 2020.
出版信息
Adv Skin Wound Care. 2021 May 1;34(5):1-6. doi: 10.1097/01.ASW.0000741512.57300.6d.
OBJECTIVE
To examine and report clinical outcomes of a ready-to-use micronized dermal matrix for diabetic foot ulcers (DFUs) and compare it to treatment with conventional negative-pressure wound therapy (NPWT) only.
METHODS
The researchers randomly allocated 30 DFUs Wagner grade 2 or higher from 30 adult patients into two groups. The control group (n = 15) was treated with conventional NPWT, and the experimental group (n = 15) was treated with micronized dermal matrix and NPWT. The researchers evaluated the following outcomes: granulation tissue formation, proportion of patients with closed or granulated wounds at 42 and 120 days, achievement of complete wound healing in the 6 months of follow-up, and intervals from enrollment to final surgical procedures.
RESULTS
All 15 wounds treated with the micronized matrix showed healthy granulation tissue without noticeable complications during follow-up. At 42 days, 46.7% of wounds in the experimental group had closed compared with 28.6% in the conventional NPWT group (P = .007). At 120 days, 86.7% of the experimental group had completely closed wounds, compared with 57.1% in the conventional therapy group (P = .040). During the 6-month follow-up period, 93.3% of the experimental group achieved complete wound healing compared with 85.7% of the conventional therapy group (P = .468).
CONCLUSIONS
The healing outcomes for DFUs in the experimental group were superior when micronized matrix treatment was combined with NPWT.
目的
研究并报告一种即用型微细化真皮基质治疗糖尿病足溃疡（DFU）的临床结果，并与单纯使用传统负压伤口治疗（NPWT）进行比较。
方法
研究人员将 30 名患有 2 级或更高级别 Wagner 分级的 DFU 的成年患者随机分为两组，每组 15 名患者。对照组（n = 15）接受常规 NPWT 治疗，实验组（n = 15）接受微细化真皮基质联合 NPWT 治疗。研究人员评估了以下结果：肉芽组织形成、42 天和 120 天时封闭或肉芽化伤口的患者比例、6 个月随访时完全愈合的伤口比例以及从入组到最终手术的间隔时间。
结果
接受微细化基质治疗的 15 个伤口在随访期间均显示出健康的肉芽组织，无明显并发症。在 42 天时，实验组有 46.7%的伤口封闭，而常规 NPWT 组为 28.6%（P =.007）。在 120 天时，实验组有 86.7%的伤口完全封闭，而常规治疗组为 57.1%（P =.040）。在 6 个月的随访期间，实验组有 93.3%的伤口完全愈合，而常规治疗组为 85.7%（P =.468）。
结论
与单纯 NPWT 治疗相比，微细化真皮基质联合 NPWT 治疗糖尿病足溃疡的愈合效果更好。
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