Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04044014
Other study ID # 189413
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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).


Read more »

Study Design


Related Conditions & MeSH terms


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)
See also
  Status Clinical Trial Phase
Not yet recruiting NCT01655407 - Safety and Efficacy Study of Autologous Engineered Skin Substitute to Treat Partial- and Full-Thickness Burn Wounds Phase 2
Not yet recruiting NCT04396951 - Optimal Heating Temperature in Major Burns Patients N/A
Completed NCT01664806 - Laparoscopic Cholecystectomy And Capacitive Coupling - Coag Versus Blend Mode Causing Thermal Injury at Port Site Skin Phase 3
Terminated NCT03148977 - Evaluating MMPs in Burns
Withdrawn NCT02689713 - Pilot Study to Compare Topical Voriconazole to Placebo as a Pain Reducing Agent Phase 2
Completed NCT00748345 - Pharmacokinetics of Caspofungin in Burn Patients Phase 2/Phase 3
Completed NCT02080546 - Vaginal Cuff Dehiscence and Thermal Injury During TLH N/A