A Controlled Study Comparing Acceptance of the Current SCD™ Compression Sleeve to a Newly Designed SCD™ Compression Sleeve in Hospitalized Patients to Reduce Venous Thromboembolism
Description
The purpose of this research study is to test a newly designed SCD Compression sleeve against the current SCD Compression Sleeve. Since clots may form in the legs as a result of blood not moving, these systems act to promote blood flow by squeezing the legs for short periods. In this study, the newly designed sleeve will be compared to the currently marketed sleeve for comfort, flexibility, fit, temperature and sweatiness. Patients will be asked to complete a questionnaire two times a day that asks questions about both of the sleeves. The study will last about 3 to 25 days depending on how long you are in the hospital for.
IRB Number
Pro201
Inclusion/Exclusion
INCLUSION:
Patient must be 18 years of age or older
Patient must be able to speak and read English
Patient must have both legs fully intact (cannot be an amputee) and have sufficient sensory capabilities to describe how the sleeves feel.
Patient legs must fit properly into the Medium Thigh Length Sleeve or the Medium Knee Length Sleeve.
Patient must be prescribed an SCD Compression Sleeve and be expected to wear the sleeves for at least 24 hours.
Patient must give written informed consent.
EXCLUSION:
Patients who are currently pregnant or breastfeeding.
Patients with local leg conditions in which the sleeves would interfere.
Patients with severe arteriosclerosis or other ischemic vascular diseases.
Patients who have a massive leg edema or pulmonary edema from congestive heart failure.
Patients with a suspected existing deep vein thrombosis (DVT).
Patients with a known history of DVT or pulmonary embolism (PE).
Status
Enrolling
Location
Texas Health Arlington Memorial and Texas Health Harris Methodist Fort Worth
