EdemaWear to Reduce Edema in Hospitalized Patients With CVI:
EdemaWear to Reduce Edema in Hospitalized Patients With CVI:
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
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

 Data analysis:

 - Descriptive statistics will be performed on demographic and physiological variables,
 including number / percent for nominal variables and mean (+SD) for continuous variables.
 Data will be analyzed to decide whether they meet the assumptions of the planned analyses.
 Repeated measures ANOVA will be used to determine whether there are significant differences
 in the volume of the lower legs treated with EdemaWear® across the five time periods. The
 alpha level will be set at p < .05.

 Qualitative data from daily interviews of patients and nursing staff will be analyzed by

 -  the PI and Co-Is of this study. Content analysis will be used to analyze the data. The
 unit of analysis will be phrases or sentences contained in responses to questions in the
 Interview Guides. Content Analysis is a qualitative research method that is used to
 isolate and interpret themes, issues, and repeated patterns. They refine understanding
 as new insights about the data emerge. The strategies for analysis outlined by Downe -
 Wamboldt will be followed.
Inclusion Criteria:

 -  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.

 Exclusion Criteria:

 -  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.