Gellan Contact Study

Study Overview
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Brief Summary
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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).

Detailed Description
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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).

Official Title
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Prospective, Randomized Control Trial to Evaluate the Dermatological Reaction of Healthy Volunteers to Gellan Sheet and Fluid Gel Dressings (Gellan Contact Study)

Conditions
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Thermal Injury, Skin Burn

Intervention / Treatment
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* Device: Gellan sheet
* Device: Gellan fluid gel
* Device: Mepitel One


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects aged ≥ 18 years old Subjects who can provide informed consent Exclusion Criteria: Subject with existing skin conditions/diseases which may interfere with the aim(s) of the study. Examples include pathological fibrosis e.g. scleroderma; pathological thinning e.g. epidermolysis bullosa and collagen disorders e.g. Marfan's syndrome Chronic steroid use, history of skin malignancy or chronic papulo-squamous disease (e.g. eczema, pemphigus) and history of Steven Johnson or TENS disease Blemishes, marks (e.g. tattoos, scars or burns,) on the test site(s) which may interfere with assessment on the test site Use of medication which may affect may affect skin response Known allergy to the materials used in the study Known allergy to adhesive plasters or tapes Fitzpatrick skin type VI (due to the difficulty of identifying erythema) Irritated skin on the test site Known pregnancy (confirmed by urine pregnancy test) or lactating Inability to commit to attending all sessions. Participation in another study which may affect the results of this contact study. Any other reason that clinician considers will interfere with the objectives of the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm A<br>Left arm: Gellan sheet; Right arm: Mepitel One. | Device: Gellan sheet<br>* Gellan sheet.<br>Device: Mepitel One<br>* Control dressing-- Mepitel One.<br>|
| Active Comparator: Arm B<br>Left arm: Mepitel One; Right arm: Gellan sheet. | Device: Gellan sheet<br>* Gellan sheet.<br>Device: Mepitel One<br>* Control dressing-- Mepitel One.<br>|
| Active Comparator: Arm C<br>Left arm: Gellan fluid gel; Right arm: Mepitel One. | Device: Gellan fluid gel<br>* Gellan fluid gel.<br>Device: Mepitel One<br>* Control dressing-- Mepitel One.<br>|
| Active Comparator: Arm D<br>Left arm: Mepitel One; Right arm: Gellan fluid gel. | Device: Gellan fluid gel<br>* Gellan fluid gel.<br>Device: Mepitel One<br>* Control dressing-- Mepitel One.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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: Erythema: 0-4 (Higher values are worse) Dryness: 0-3 (Higher values are worse) Oedema: 0-1 (Higher values are worse) Each subscale is evaluated individually and not combined. | 3 days (72 hours+/-3 hours) | 

Secondary Outcome Measures

| Outcome Measure | 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: Was the dressing comfortable? (Yes/No) Was there any itch? (Yes/No) Was there any pain? (Yes/No) Was the dressing comfortable to remove? (Yes/No) | At end of study (after 3 days) | 
| 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: Is the dressing still moist? (Yes/No) Is the dressing still intact? (Yes/No) Has any fragmentation occurred? (Yes/No) Has any tearing occurred? (Yes/No) | At end of study (after 3 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gellan, thermal injury, healthy volunteers, skin