Thermal InjuryGCSNCT04044014
Gellan Contact Study
A study testing Gellan sheet, Gellan fluid gel and Mepitel One in people with Thermal Injury and Skin Burn, run by University of Birmingham at 1 site in United Kingdom.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Thermal Injury, Skin Burn
- What is being tested?
- Gellan sheet, Gellan fluid gel and Mepitel One
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Oct 2016to 1 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female subjects aged ≥ 18 years old
- Subjects who can provide informed consent
Who cannot join
- 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
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country.
United Kingdom1 site
Wellcome Trust Clinical Research Facility
Birmingham, West Midlands, B15 2TH
About this study
Official title: 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).
Read the 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).
- Conditions
- Thermal Injury, Skin Burn
- Being tested
- Gellan sheet, Gellan fluid gel, Mepitel One
- Keywords
- Gellan, thermal injury, healthy volunteers, skin
- Medical subject headings
- Paresthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gellan sheetDevice
Gellan sheet.
Gellan fluid gelDevice
Gellan fluid gel.
Mepitel OneDevice
Control dressing-- Mepitel One.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Active comparator | Left arm: Gellan sheet; Right arm: Mepitel One. Receives: Device: Gellan sheet; Device: Mepitel One |
| Arm B | Active comparator | Left arm: Mepitel One; Right arm: Gellan sheet. Receives: Device: Gellan sheet; Device: Mepitel One |
| Arm C | Active comparator | Left arm: Gellan fluid gel; Right arm: Mepitel One. Receives: Device: Gellan fluid gel; Device: Mepitel One |
| Arm D | Active comparator | Left arm: Mepitel One; Right arm: Gellan fluid gel. Receives: Device: Gellan fluid gel; Device: Mepitel One |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 days (72 hours+/-3 hours)
Secondary outcomes (2)
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)
Measured: 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)
Measured: At end of study (after 3 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2019
- Study start10 Oct 2016
- Primary completion13 Feb 2017
- Study completion1 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thermal InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Wellcome Trust, University Hospital Birmingham
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04044014
- Sponsor's protocol ID
- 189413
- Acronym
- GCS
- Status last verified
- Sep 2018
- First submitted
- 14 Sep 2017
- Last updated
- 2 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share IPD.
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized Control Trial to Evaluate the Dermatological Reaction of Healthy Volunteers to Gellan Sheet and Fluid Gel Dressings (Gellan Contact Study)
- ClinicalTrials.gov ID
- NCT04044014
- Acronym / sponsor ID
- GCS / 189413
- Conditions
- Thermal Injury, Skin Burn
- Keywords
- Gellan, thermal injury, healthy volunteers, skin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Collaborators
- Wellcome Trust, University Hospital Birmingham
- Study start
- 10 Oct 2016 (actual)
- Primary completion
- 13 Feb 2017 (actual)
- Study completion
- 1 Aug 2017 (actual)
- First posted
- 2 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Device: Gellan sheet, Device: Mepitel OneLeft arm: Gellan sheet; Right arm: Mepitel One. |
| Arm B | Active comparator | Device: Gellan sheet, Device: Mepitel OneLeft arm: Mepitel One; Right arm: Gellan sheet. |
| Arm C | Active comparator | Device: Gellan fluid gel, Device: Mepitel OneLeft arm: Gellan fluid gel; Right arm: Mepitel One. |
| Arm D | Active comparator | Device: Gellan fluid gel, Device: Mepitel OneLeft arm: Mepitel One; Right arm: Gellan fluid gel. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female subjects aged ≥ 18 years old
- Subjects who can provide informed consent
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gellan sheetGellan sheet. | Device | Arm A, Arm B |
| Gellan fluid gelGellan fluid gel. | Device | Arm C, Arm D |
| Mepitel OneControl dressing-- Mepitel One. | Device | Arm A, Arm B, Arm C, Arm D |
Primary outcome
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.
2 secondary outcomes
Participant satisfaction with dressing
Time frame: At end of study (after 3 days)
Clinician satisfaction with dressing
Time frame: At end of study (after 3 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2019.
- Individual participant dataSharing planned: No. No plan to share IPD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gellan sheet, Gellan fluid gel and Mepitel One in people with Thermal Injury and Skin Burn, run by University of Birmingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin reaction (time frame: 3 days (72 hours+/-3 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2019; AzTrials last refreshed its copy on 30 Oct 2026.