Gellan Contact Study

NCT04044014 | Completed

• 1 other identifier: 189413
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Thermal Injury; Skin Burn

Keywords

Gellan, thermal injury, healthy volunteers, skin

Outcome Measures

Primary Outcomes (1)

• 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: 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 Outcomes (2)

• Participant satisfaction with dressing

  At end of study (after 3 days)

• Clinician satisfaction with dressing

  At end of study (after 3 days)

Study Arms (4)

Arm A

ACTIVE COMPARATOR

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

Device: Gellan sheet; Device: Mepitel One

Arm B

ACTIVE COMPARATOR

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

Device: Gellan sheet; Device: Mepitel One

Arm C

ACTIVE COMPARATOR

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

Device: Gellan fluid gel; Device: Mepitel One

Arm D

ACTIVE COMPARATOR

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

Device: Gellan fluid gel; Device: Mepitel One

Interventions

Gellan sheet DEVICE

Gellan sheet.

Arm A; Arm B

Gellan fluid gel DEVICE

Gellan fluid gel.

Arm C; Arm D

Mepitel One DEVICE

Control dressing-- Mepitel One.

Arm A; Arm B; Arm C; Arm D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects aged ≥ 18 years old
• Subjects who can provide informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Birmingham: lead
• Wellcome Trust: collaborator
• University Hospital Birmingham: collaborator

Study Sites (1)

Wellcome Trust Clinical Research Facility

Birmingham, West Midlands, B15 2TH, United Kingdom

Location

MeSH Terms

Conditions

Paresthesia

Condition Hierarchy (Ancestors)

Somatosensory Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Two assessors will be evaluating the skin for erythema, dryness and oedema. They will be blinded to which arm has received the treatment and control.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 14, 2017
• First Posted: August 2, 2019
• Study Start: October 10, 2016
• Primary Completion: February 13, 2017
• Study Completion: August 1, 2017
• Last Updated: August 2, 2019

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)