Gellan Contact Study

Thermal Injury Clinical Trial

— GCS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04044014
• Other study ID #: 189413
• Status: Completed
• Phase: N/A
• Start date: October 10, 2016
• Est. completion date: August 1, 2017

Study information

• Verified date: September 2018
• Source: University of Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: August 1, 2017
• Est. primary completion date: February 13, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Skin Burn
• Thermal Injury

Intervention

Device:
• Gellan sheet
Gellan sheet.
• Gellan fluid gel
Gellan fluid gel.
• Mepitel One
Control dressing-- Mepitel One.

Locations

Country	Name	City	State
United Kingdom	Wellcome Trust Clinical Research Facility	Birmingham	West Midlands

Sponsors (3)

Lead Sponsor	Collaborator
University of Birmingham	University Hospital Birmingham, Wellcome Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)