Gellan Contact Study (GCS)

August 1, 2019 updated by: University of Birmingham

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B15 2TH
        • Wellcome Trust Clinical Research Facility

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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:

  1. Erythema: 0-4 (Higher values are worse)
  2. Dryness: 0-3 (Higher values are worse)
  3. 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
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:

  1. Was the dressing comfortable? (Yes/No)
  2. Was there any itch? (Yes/No)
  3. Was there any pain? (Yes/No)
  4. Was the dressing comfortable to remove? (Yes/No)
At end of study (after 3 days)
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:

  1. Is the dressing still moist? (Yes/No)
  2. Is the dressing still intact? (Yes/No)
  3. Has any fragmentation occurred? (Yes/No)
  4. Has any tearing occurred? (Yes/No)
At end of study (after 3 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Birmingham

Collaborators

Wellcome Trust
University Hospital Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2016

Primary Completion (Actual)

February 13, 2017

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

September 14, 2017

First Submitted That Met QC Criteria

August 1, 2019

First Posted (Actual)

August 2, 2019

Study Record Updates

Last Update Posted (Actual)

August 2, 2019

Last Update Submitted That Met QC Criteria

August 1, 2019

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 189413

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan to share IPD.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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