Ex vivo evaluation of the clinical performance of an elastic crepe or support bandage for the treatment of varicose veins

Rathnaganpathi Thulasikumar Dr med , Manoj Prabakar Ravichandran Dr med , Ferdinand Tamoue PhD , Thulasikumar Ganapathy Dr med
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Abstract

Background

Varicose vein is a progressive disease that does not have remission except after pregnancy and delivery. It is a type of venous insufficiency that presents with dilated, tortuous, elongated veins owing to the permanent loss of the valvular efficiency. The aim of the study is to demonstrate the health care professionals can consistently achieve a sub-bandage interface pressure of 30 ± 10 mm Hg using an Elastic Crepe Bandage, ECB-394, or its derivatives, which has similar viscoelastic properties, to treat patients with varicose veins.

Methods

This study was conducted among the varicose vein patients attending Sree Parthas Multispecialty Hospital and the Department of Vascular Surgery over a period of 3 months. Patients were screened for the study from November 2023 to February 2024. Based on the inclusion and exclusion criteria, study participants were recruited. The final sample size was 35. Demographic details were recorded. Sub-bandage pressure was measured with the Pico Press sensor. The data collected were entered in Excel Sheet and analysis were done by SPSS 23. A P value of less than .05 was considered as statistically significant.

Results

The mean age of the study participants was 42.37 ± 12.09 years, with a minimum age of 22 years and a maximum of 72 years. Males were predominant in our study, accounting for 27 participants (77.1%). Systemic hypertension, present in six patients (17.1%), was the most common comorbidity. A statistically significant difference was observed between the initial and final pressure measurements. Compliance and safety were found to be 100% among the study participants. Efficacy was observed in 80% of the participants, although adherence was only noted in 60%.

Conclusions

The study demonstrates the effectiveness and safety of the intervention, with a high compliance rate and a statistically significant improvement in pressure outcomes. However, adherence remains a key area for further improvement.
弹性绉或支撑绷带治疗静脉曲张临床性能的体外评价
背景:静脉曲张是一种进行性疾病,除非在怀孕和分娩后才有缓解。这是一种静脉功能不全的类型,由于瓣膜效率的永久丧失,静脉扩张,扭曲,拉长。本研究的目的是证明医疗保健专业人员可以使用弹性皱纹绷带(ECB-394)或其衍生物(具有类似的粘弹性特性)持续地达到30±10毫米汞柱的绷带界面压力,以治疗静脉曲张患者。方法本研究对在Sree Parthas多专科医院血管外科就诊的静脉曲张患者进行为期3个月的研究。患者从2023年11月到2024年2月进行了研究筛选。根据纳入和排除标准,招募研究参与者。最终样本量为35。记录了人口统计细节。用Pico Press传感器测量绷带下压力。收集的数据在Excel表格中输入,并使用SPSS 23进行分析。P值小于0.05认为有统计学意义。结果研究对象平均年龄42.37±12.09岁,最小年龄22岁,最大年龄72岁。男性在我们的研究中占主导地位,占27名参与者(77.1%)。6例患者(17.1%)出现全身性高血压,是最常见的合并症。在初始和最终压力测量之间观察到统计学上显著的差异。研究参与者的依从性和安全性均为100%。80%的参与者观察到疗效,尽管只有60%的参与者注意到依从性。结论本研究证明了干预的有效性和安全性,依从率高,压力结局有统计学意义上的改善。然而,依从性仍然是进一步改善的关键领域。
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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