Efficacy of Adhesive Strength of New Hydrogel Formulation
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Stroke Acute
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: A prospective, non-blinded service evaluation of two sequential groups of patients carried out in two phases.Masking: None (Open Label)Primary Purpose: Basic Science
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 n...
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.
Tracking Information
- NCT #
- NCT04309110
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Indira Natarajan, FRCP University Hospitals of North Midlands NHS Trust
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