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| Name | Class |
|---|---|
| Wellcome Trust | OTHER |
| University Hospital Birmingham | OTHER |
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The primary objective of this study will be to establish the safety of the two different Gellan formulations (sheet and fluid gel) following its application to the epidermis of healthy volunteers. This will be compared to a control dressing-- Mepitel One (Polyurethane net with soft Silicone).
This contact study is part of the Wellcome trust Anti-scarring Dressing project to develop a carrier dressing that will be used to deliver therapeutic agents to the skin. A polysaccharide, Gellan, has been chosen as the main component of this dressing (the biomembrane)and it can be produced in either a sheet or fluid gel forms. Gellan is a widely used material in both the food and medical industry e.g. as a lubricant in eye-drops (e.g. Timoptol XE, Merck Sharp & Dohme, USA).
As part of the development of the dressing, the epidermal (skin) response to Gellan needs to be evaluated to check its safety.
The main objective of this study is to establish the safety of the two different Gellan formulations (2% Gellan sheet and 2% Gellan fluid gel) following application to the epidermis (skin).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Active Comparator | Left arm: Gellan sheet; Right arm: Mepitel One. |
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| Arm B | Active Comparator | Left arm: Mepitel One; Right arm: Gellan sheet. |
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| Arm C | Active Comparator | Left arm: Gellan fluid gel; Right arm: Mepitel One. |
|
| Arm D | Active Comparator | Left arm: Mepitel One; Right arm: Gellan fluid gel. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gellan sheet | Device | Gellan sheet. |
| |
| Gellan fluid gel |
| Measure | Description | Time Frame |
|---|---|---|
| Skin reaction | Skin will be evaluated for erythema, dryness and oedema by two observers using a visually based scale (Visual skin assessment scale; this is a novel scale devised by the research team). The scale is as follows:
Each subscale is evaluated individually and not combined. | 3 days (72 hours+/-3 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Participant satisfaction with dressing | Participant satisfaction in terms of pain, itch, comfort and ease of removal (evaluated using a questionnaire). Name of questionnaire: "Participant evaluation questionnaire" Questions:
| At end of study (after 3 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wellcome Trust Clinical Research Facility | Birmingham | West Midlands | B15 2TH | United Kingdom |
No plan to share IPD.
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| ID | Term |
|---|---|
| D010292 | Paresthesia |
| ID | Term |
|---|---|
| D020886 | Somatosensory Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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Participants will be randomised to receive the treatment dressing (either the Gellan sheet or Gellan fluid gel) on one arm (Left or Right), and the control dressing (Mepitel One) on the other arm. The first phase will be for 1 hour and the 2nd phase will be for 3 days.
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Two assessors will be evaluating the skin for erythema, dryness and oedema. They will be blinded to which arm has received the treatment and control.
| Device |
Gellan fluid gel. |
|
| Mepitel One | Device | Control dressing-- Mepitel One. |
|
| Clinician satisfaction with dressing | Clinician satisfaction in terms of ease of application, handling, removal, durability, conformity (evaluated using a questionnaire). Name of questionnaire: "Clinician evaluation questionnaire" Questions:
| At end of study (after 3 days) |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |