Shapira Eyal, Govrin-Yehudain Yoad, Heller Lior
Department of Plastic Surgery, Shamir Medical Center, Zerifin, Israel.
Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Scars Burn Heal. 2023 May 24;9:20595131231174225. doi: 10.1177/20595131231174225. eCollection 2023 Jan-Dec.
INTRODUCTION: Venous leg ulcers are the most common cause of leg ulcers. The aim of this study is to assess the effect of Combined Ultrasound and Electric Field Stimulation therapies (CUSEFS) on wound surface area and pain level in patients with venous leg ulcers, utilizing a novel device (BRH-A2 from BRH Medical, Ltd). METHODS: This prospective case series study, conducted by the Department of Plastic Surgery at the Yitzhak Shamir Medical Center, Israel, collected data for subjects treated with CUSEFS with the BRH-A2 device, between April 2018 and September 2019. Measurements of wound area and assessment of pain intensity using a 10-point visual analog score were recorded. At the end of the four-week period, average wound area and pain scores were included for analysis. RESULTS: Ten consecutive patients met the inclusion criteria. During the study period, all patients exhibited a reduction in the wound surface area. The final average wound surface area was reduced by 53.52% following the combined treatment. Eight out of the ten patients (80%) reported a reduction in pain, with an average pain level reduction of 64% throughout eight consecutive treatments. CONCLUSION: CUSEFS therapies with BRH-A2 technology is a promising treatment for venous leg ulcers. In accordance with our preliminary results, this treatment modality can aid in the reduction of wound surface area as well as reducing the pain suffered by patients from these chronic wounds. Larger multicenter studies are needed to further quantify and qualify the beneficial effect of CUSEFS in venous leg ulcers and other chronic wounds. LAY SUMMARY: Venous leg ulcers (VLUs) are painful wounds occurring between the knee and ankle joint, that fail to heal for a period of at least two weeks and occur in the presence of venous disease. VLUs, are the most common cause of leg ulcers, affecting approximately 5% of the general population over the age of 65. Numerous non-invasive treatment modalities have been attempted for healing chronic wounds and ulceration, however, in some instances surgery, although invasive, is the preferred option. For many years, ultrasound (US) has been used therapeutically to treat chronic ulcers. US produces biophysical effects that are significantly beneficial to the wound healing process. Electrical stimulation therapy is another treatment option which contributes to wound healing by influencing the electrochemical wound process.Combined Modulated Ultrasound and Electric Field Stimulation (CUSEFS) have been shown to improve the healing of chronic wounds. However, research has focused predominantly on objective measures of healing, while less consideration has been given to researching the subjective discomfort and the negative impact that ulceration places on the patient. The aim of this study was to assess objective and subjective factors by measuring the short-term effect of CUSEFS on the surface area of wound and on pain levels in patients with venous leg ulcers (VLUs). Our study findings demonstrate that the combined treatment was effective in initiating wound healing and reducing levels of pain in chronic, stagnant, recalcitrant venous leg ulcers.
引言:下肢静脉性溃疡是腿部溃疡最常见的病因。本研究旨在评估联合超声与电场刺激疗法(CUSEFS),使用一种新型设备(BRH Medical有限公司生产的BRH-A2)对下肢静脉性溃疡患者伤口表面积和疼痛程度的影响。 方法:本前瞻性病例系列研究由以色列伊扎克·沙米尔医疗中心整形外科进行,收集了2018年4月至2019年9月期间使用BRH-A2设备接受CUSEFS治疗的受试者的数据。记录伤口面积测量值,并使用10分视觉模拟评分法评估疼痛强度。在四周疗程结束时,纳入平均伤口面积和疼痛评分进行分析。 结果:连续10名患者符合纳入标准。在研究期间,所有患者的伤口表面积均减小。联合治疗后最终平均伤口表面积减小了53.52%。10名患者中有8名(80%)报告疼痛减轻,在连续8次治疗中平均疼痛程度减轻了64%。 结论:采用BRH-A2技术的CUSEFS疗法是治疗下肢静脉性溃疡的一种有前景的治疗方法。根据我们的初步结果,这种治疗方式有助于减小伤口表面积,并减轻患者因这些慢性伤口所遭受的疼痛。需要开展更大规模的多中心研究,以进一步量化和验证CUSEFS对下肢静脉性溃疡及其他慢性伤口的有益效果。 简要概述:下肢静脉性溃疡(VLU)是发生在膝关节和踝关节之间的疼痛性伤口,至少两周未愈合且存在静脉疾病。VLU是腿部溃疡最常见的病因,影响约5%的65岁以上普通人群。人们尝试了多种非侵入性治疗方法来治愈慢性伤口和溃疡,然而在某些情况下,手术虽然具有侵入性,但却是首选方案。多年来,超声(US)一直被用于治疗慢性溃疡。超声产生的生物物理效应对伤口愈合过程具有显著益处。电刺激疗法是另一种治疗选择,通过影响伤口的电化学过程促进伤口愈合。联合调制超声和电场刺激(CUSEFS)已被证明可改善慢性伤口的愈合。然而,研究主要集中在愈合的客观指标上,而较少考虑研究主观不适以及溃疡对患者的负面影响。本研究的目的是通过测量CUSEFS对下肢静脉性溃疡(VLU)患者伤口表面积和疼痛程度的短期影响,评估客观和主观因素。我们的研究结果表明,联合治疗在启动慢性、停滞、难治性下肢静脉性溃疡的伤口愈合和减轻疼痛程度方面是有效的。
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