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Completed

NCT Number: NCT04044014

Gellan Contact Study

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).

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Key information

Conditions

Thermal Injury Nervous System Diseases Neurologic Manifestations Paresthesia Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Skin Burn Somatosensory Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wellcome Trust Clinical Research Facility

Birmingham, West Midlands, B15 2TH, United Kingdom

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gellan sheet

Device

Gellan sheet.

Gellan fluid gel

Device

Gellan fluid gel.

Mepitel One

Device

Control dressing-- Mepitel One.

Primary outcomes

  1. Skin reaction

    Time frame: 3 days (72 hours+/-3 hours)

    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.

Secondary outcomes

  1. Participant satisfaction with dressing

    Time frame: At end of study (after 3 days)

    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)

  2. Clinician satisfaction with dressing

    Time frame: At end of study (after 3 days)

    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)

Sponsors and collaborators

Lead sponsor

University of Birmingham

Other

Collaborators

  • University Hospital Birmingham
  • Wellcome Trust

Registry information

Official study title

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

Acronym: GCS

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 2, 2019
Registry last updated
Aug 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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