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This study hypothesises that the gekoâ„¢ device is more efficient than TEDS in preventing the formation of symptomatic/asymptomatic Deep Vein Thrombosis (DVTs), post-surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| gekoâ„¢ | Experimental | gekoâ„¢ use continually post-surgery for 48hrs and then a minimum of 4hrs/day until discharge |
|
| TEDS stockings | Active Comparator | TEDS use continually post-surgery for 48hrs and then a minimum of 4hrs/day until discharge |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gekoâ„¢ post-surgery for 48hrs then 4hrs/day until discharge. | Device |
| ||
| TEDS post-surgery for 48hrs then 4hrs/day until discharge. |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of asymptomatic DVT assessed by Duplex Ultrasound | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Are requiring hip revision surgery
History or signs of previous deep or superficial vein thrombosis/pulmonary embolism.
Evidence of asymptomatic DVT by Duplex Ultrasound
Peripheral arterial disease (ABPI < 0.8), varicose veins or lower limb ulceration or ischemia.
Significant varicose veins, phlebitis or lower limb ulceration or ischemia. CEAP Grade 4-6. See Appendix 2
Recent surgery within the last 3 months (such as abdominal, gynaecological, hip or knee replacement).
Recent trauma to lower limb.
Chronic Obesity (BMI Index >40kg/m2).
Pregnancy.
Significant history of following diseases I. Cardiovascular: Recent MI (< 6 months) II. Percutaneous Coronary Intervention (PCI) with stent (< 3 months for Bare Metal Stent (BMS) and < 12 months for Drug Eluding Stent (DES) III. Moderate to severe CCF, uncontrolled AF IV. Neurological: Stroke, Hemiplegia/Paraplegia, Myopathies V. Significant dermatological conditions affecting lower limbs resulting in broken or inflamed skin particularly at the site where the device is to be fitted.
VI. Clinically significant haematological conditions i.e. coagulation disorders, sickle cell disease VII. Psychiatric disorders
On LMWH/Heparin (Prophylactic/therapeutic doses) or Warfarin or warfarin stopped recently and replaced by LMWH/ Heparin
Long term steroid with dermatological changes
A pulse rate of less than 40 beats/minute
A sitting systolic blood pressure >180 and <100 mmHg and/or a sitting diastolic pressure of >100 mmHg.
Any significant illness during the four (4) weeks preceding the hip replacement surgery.
Participation in any clinical study during the eight (8) weeks preceding the screening period
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BMI The Harbour Hospital | Poole | Dorset | BH15 2BH | United Kingdom |
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| Label | URL |
|---|---|
| Company website | View source |
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| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Device |
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