Clinical trial NCT04309110: Efficacy of Adhesive Strength of New Hydrogel Formulation
Official title: Evaluation of the Adhesive Strength of the Geko™ X-T3 Neuromuscular Stimulator Incorporating a New Skin Adhesive Hydrogel Formulation Designated KM40C
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke, Acute
Lead sponsor: Firstkind Ltd
Sponsor class: INDUSTRY
First posted: 2020-03-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: A prospective, non-blinded service evaluation of two sequential groups of patients carried out in two phases.
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Efficacy of the Skin Adhesive Strength of Hydrogel KM40C Compared to That of Hydrogel KM10T.
timeFrame: 10 days
Secondary outcomes:
measure: Incidence of Adverse Events
timeFrame: 10 days
Other outcomes:
Locations:
city: Stoke-on-Trent
country: United Kingdom
facility: University Hospitals of North Midlands NHS Trust
Study officials:
affiliation: University Hospitals of North Midlands NHS Trust
name: Indira Natarajan, FRCP
role: PRINCIPAL_INVESTIGATOR
References: