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临床试验/NCT03904602
NCT03904602终止不适用

EdemaWear to Reduce Edema in Hospitalized Patients With Chronic Venous Insufficiency: A Pilot Study

Massachusetts General Hospital2 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2019年8月19日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
3
试验地点
2
主要终点
change in lower leg volume

研究概览

简要总结

The purpose of this pilot study is to evaluate the effectiveness of EdemaWear® fuzzy wale longitudinal compression stockings on reducing lower extremity edema in hospitalized adult patients with a history of CVI who are at high risk of consequent venous leg ulcers (VLU) and patient experience with continuously wearing Edema Wear for up to five days

详细描述

Hospitalized patients with chronic venous insufficiency (CVI) are at high risk of venous leg ulcers (VLU) due to lower leg edema and skin changes. Since VLU are associated with prolonged morbidity and appreciable financial burden to the patient and society, prevention of VLU by reduction of lower leg edema is paramount. Although the mainstay of VLU prevention is compression, there is a gap in the acute care toolbox to manage the symptom of CVI edema. Currently, ACE bandages are the single most common 'compression wraps' stocked on inpatient units. The disadvantages of ace wraps, which are long-stretch bandages, are two-fold: 1) lower working pressure impeding venous return to the heart, and 2) higher resting pressure that may cause a tourniquet effect and consequent tissue ischemia. A newer moderately-priced mild compression product (15-20 mmHg), EdemaWear® longitudinal elastic compression stockinet, offers an alternative for hospitalized patients. There is limited evidence about the effectiveness of EdemaWear® (that is, modest reduction of lower leg edema) derived from one case series and two comparative evaluations involving only patients in out-patient clinics. This pilot study will expand the evidence related to the effectiveness of EdemaWear® in reducing lower leg edema to include hospitalized patients with CVI. .

The proposed pilot interventional study which involves a single-group repeated measures design with mixed methods has three aims:

  1. evaluate the effectiveness of EdemaWear fuzzy wale elastic compression stockinet in reducing lower extremity edema in hospitalized adult patients with chronic venous insufficiency as measured by the difference in the volume of each lower extremity from Day 1 and Day 5 of data collection or the day of discharge if it occurs in less than five days
  2. determine through interviews the experience of patients continuously wearing EdemaWear compression garment for up to five days or hospital discharge if it occurs in less than five days
  3. qualitatively describe nurses' perceptions of their patients experience with continuously wearing EdemaWear compression garment for up to five days or hospital discharge if it occurs in less than five days

The procedure:

  • Initial data collection related to demographic variables (age, gender, race, ethnic background), primary diagnosis, comorbid conditions (Charlson Comorbidity Index), CEAP classification of chronic venous disease, medication / treatment regimen, degree of lower extremity edema, volume of lower leg peripheral pulses, ankle-brachial indexes
  • Daily data collection related to changes in health status and treatment
  • Daily measurement of the girth of both lower extremities at 10 cm intervals from mid-foot, up the legs, to just below the knees.
  • Daily interviews of patient and nursing staff related to experience of continuously wearing EdemaWear for up to five days or hospital discharge if it occurs in less than five days

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • history of CVI (Clinical classification 1-5), with > 2+ edema of the lower legs,
  • > 2+ peripheral pulses (popliteal, dorsalis pedis [DP], and posterior tibial [PT]) or audible biphasic / triphasic Doppler signal, if pulses not palpable.

排除标准

  • open venous stasis ulcer(s) or other wounds on lower legs
  • lymphedema or risk factors for lymphedema
  • acute heart failure with active management
  • known deep vein thrombosis (DVT) with subtherapeutic anticoagulation
  • peripheral arterial disease (PAD) with reduced / absent pulses
  • known or suspected inferior vena caval (IVC) compression
  • circumference of lower leg < 45 cm or > 115 cm (size limits of small and extra-large EdemaWear®)
  • severely altered mental status or lacking capacity to consent.

结局指标

主要结局

change in lower leg volume

时间窗: up to 5 days

Difference between volume of lower leg / foot between Day 1 and Day 5 (or day of hospital discharge if less than 5 days)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Virginia Capasso

Clinical Nurse Specialist

Massachusetts General Hospital

研究点 (2)

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