Efficacy of Adhesive Strength of New Hydrogel Formulation

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-13

Study Completion Date

2021-11-25

Brief Summary

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The study will look at the stickiness of a new skin adhesive incorporated into a new next generation geko™ device called the geko™ X-T3 and compare it to the adhesive currently used into the geko™ T3 device. The study is for people who are in hospital in the Acute Stroke Unit, and who will be receiving daily treatment with the geko™ T3 device in line with UK guidelines as part of their standard acute stroke care and venous thromboembolism prevention.

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Detailed Description

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The new skin adhesive incorporated into the next generation geko™ device designated geko™ XT-3 has previously been tested to current international biocompatibility standards (ISO10993) , however the skin adhesive strength of the geko™ X-T3 device compared to that of the current geko™ T3 device has not yet been tested. The reason behind the study is to compare the skin adhesive strength of the two devices in a similar use environment, to determine whether the geko™ XT-3 device will be a suitable replacement for the geko™ T3 device.

In total 40 people who are patients in hospital in the Acute Stroke Unit, and who will receive daily treatment with the geko™ T3 device as part of their acute stroke care and venous thromboembolism prevention pathway will be asked if they would like to take part in the study. 20 patients will receive their normal daily treatment with the currently in use geko™ T3 device and 20 patients will receive their normal daily treatment with the new geko™ XT-3 device which has the new skin adhesive.

Phase 1 will take place before Phase 2 and each phase will last for a maximum of 10 days or until patients are able to walk independently. Each day during the study and after their standard treatment has been completed, a member of the healthcare team will ask the patient questions about their experience with geko™ device and the answers recorded.

The standard acute stroke care patients receive when on the study will not be affected, regardless of which geko™ device they receive and because the study fits into the normal treatment given to these stroke patients whilst in hospital there will be no additional study visits.

Conditions

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Stroke, Acute

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

A prospective, non-blinded service evaluation of two sequential groups of patients carried out in two phases.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Standard care with geko™ T3 device

Current geko™ device incorporating hydrogel adhesive designated KM10T

Group Type NO_INTERVENTION

No interventions assigned to this group

geko™ X-T3

Next generation geko™ device incorporating new hydrogel adhesive designated KM40C

Group Type ACTIVE_COMPARATOR

or geko™ X-T3

Intervention Type DEVICE

The geko™ X-T3 is a next generation self adhesive medical device incorporating a new formulation skin adhesive. It is about the size of a wrist watch which attaches to the side of the knee and when switched on, gentle painless electrical pulses are produced which contract the calf muscles and increase blood flow to the lower leg. The only difference between the currently used geko™ T3 device and the new geko™ XT-3 device is the adhesive used to attach each device to the skin.

Interventions

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or geko™ X-T3

The geko™ X-T3 is a next generation self adhesive medical device incorporating a new formulation skin adhesive. It is about the size of a wrist watch which attaches to the side of the knee and when switched on, gentle painless electrical pulses are produced which contract the calf muscles and increase blood flow to the lower leg. The only difference between the currently used geko™ T3 device and the new geko™ XT-3 device is the adhesive used to attach each device to the skin.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Male or female aged ≥ 18 years
* Currently an in-patient hospitalised for acute stroke
* Use of geko™ as a mechanical prophylaxis strategy for venous thromboembolism
* Patient understands and is willing to participate in the study and is able to comply with study procedures

Exclusion Criteria

* Pregnancy or breast feeding
* Use of any neuro-modulation device other than geko™
* Participation in any other clinical study that may interfere with the outcome of either study

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No