Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
33 participants
INTERVENTIONAL
2016-10-10
2017-08-01
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Arm A
Left arm: Gellan sheet; Right arm: Mepitel One.
Gellan sheet
Gellan sheet.
Mepitel One
Control dressing-- Mepitel One.
Arm B
Left arm: Mepitel One; Right arm: Gellan sheet.
Gellan sheet
Gellan sheet.
Mepitel One
Control dressing-- Mepitel One.
Arm C
Left arm: Gellan fluid gel; Right arm: Mepitel One.
Gellan fluid gel
Gellan fluid gel.
Mepitel One
Control dressing-- Mepitel One.
Arm D
Left arm: Mepitel One; Right arm: Gellan fluid gel.
Gellan fluid gel
Gellan fluid gel.
Mepitel One
Control dressing-- Mepitel One.
Interventions
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Gellan sheet
Gellan sheet.
Gellan fluid gel
Gellan fluid gel.
Mepitel One
Control dressing-- Mepitel One.
Eligibility Criteria
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Inclusion Criteria
* Subjects who can provide informed consent
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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Wellcome Trust
OTHER
University Hospital Birmingham
OTHER
University of Birmingham
OTHER
Responsible Party
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Locations
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Wellcome Trust Clinical Research Facility
Birmingham, West Midlands, United Kingdom
Countries
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Other Identifiers
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189413
Identifier Type: -
Identifier Source: org_study_id
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