Geko Neuromuscular Stimulator vs Thromboembolism Deterrent Stockings (TEDS): DVT Prevention Study

Firstkind

Status: Completed

Conditions: Deep Vein Thrombosis

Treatments: Device: TEDS post-surgery for 48hrs then 4hrs/day until discharge.; Device: geko™ post-surgery for 48hrs then 4hrs/day until discharge.

Study type: Interventional

Funder types: Industry

Identifiers

NCT01935414

FKD-TEDS-001

Details and patient eligibility

About

This study hypothesises that the geko™ device is more efficient than TEDS in preventing the formation of symptomatic/asymptomatic Deep Vein Thrombosis (DVTs), post-surgery.

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Aged 18 years of age and over
2. Free of significant abnormal findings as determined by medical history (specifically an absence of DVT or haematological disorders).
3. Has not used any medications (prescribed or over-the-counter including herbal remedies) judged to be significant by the Principal Investigator during the ten (10) days preceding enrolment.
4. Able to understand the Patient Information Sheet and willing to sign the written Informed Consent Form.
5. Able and willing to follow the protocol requirements.

Exclusion criteria

1. Are requiring hip revision surgery

2. History or signs of previous deep or superficial vein thrombosis/pulmonary embolism.

3. Evidence of asymptomatic DVT by Duplex Ultrasound

4. Peripheral arterial disease (ABPI < 0.8), varicose veins or lower limb ulceration or ischemia.

5. Significant varicose veins, phlebitis or lower limb ulceration or ischemia. CEAP Grade 4-6. See Appendix 2

6. Recent surgery within the last 3 months (such as abdominal, gynaecological, hip or knee replacement).

7. Recent trauma to lower limb.

8. Chronic Obesity (BMI Index >40kg/m2).

9. Pregnancy.

10. 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

11. On LMWH/Heparin (Prophylactic/therapeutic doses) or Warfarin or warfarin stopped recently and replaced by LMWH/ Heparin

12. Long term steroid with dermatological changes

13. A pulse rate of less than 40 beats/minute

14. A sitting systolic blood pressure >180 and <100 mmHg and/or a sitting diastolic pressure of >100 mmHg.

15. Any significant illness during the four (4) weeks preceding the hip replacement surgery.

16. Participation in any clinical study during the eight (8) weeks preceding the screening period

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

geko™

Experimental group

Description:

geko™ use continually post-surgery for 48hrs and then a minimum of 4hrs/day until discharge

Treatment:

Device: geko™ post-surgery for 48hrs then 4hrs/day until discharge.

TEDS stockings

Active Comparator group

Description:

TEDS use continually post-surgery for 48hrs and then a minimum of 4hrs/day until discharge

Treatment:

Device: TEDS post-surgery for 48hrs then 4hrs/day until discharge.