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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2016-11-16

Brief Summary

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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.

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Detailed Description

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Conditions

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Deep Vein Thrombosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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geko™

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

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

TEDS stockings

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

Interventions

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

Intervention Type DEVICE

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No