Gellan Contact Study (GCS)

University of Birmingham

Status: Completed

Conditions: Thermal Injury; Skin Burn

Treatments: Device: Gellan sheet; Device: Mepitel One; Device: Gellan fluid gel

Study type: Interventional

Funder types: Other

Identifiers

NCT04044014

189413

Details and patient eligibility

About

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).

Full description

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).

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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33 participants in 4 patient groups

Arm A

Active Comparator group

Description:

Left arm: Gellan sheet; Right arm: Mepitel One.

Treatment:

Device: Mepitel One

Device: Gellan sheet

Arm B

Active Comparator group

Description:

Left arm: Mepitel One; Right arm: Gellan sheet.

Treatment:

Device: Mepitel One

Device: Gellan sheet

Arm C

Active Comparator group

Description:

Left arm: Gellan fluid gel; Right arm: Mepitel One.

Treatment:

Device: Gellan fluid gel

Device: Mepitel One

Arm D

Active Comparator group

Description:

Left arm: Mepitel One; Right arm: Gellan fluid gel.

Treatment:

Device: Gellan fluid gel

Device: Mepitel One