Efficacy of Adhesive Strength of New Hydrogel Formulation

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04309110
Study type	Interventional
Source	Firstkind Ltd
Contact
Status	Completed
Phase	N/A
Start date	July 13, 2021
Completion date	November 25, 2021

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.