Prospective, Randomized, Non-inferiority Investigation to Compare Effects of Mepitel® One and UrgoTul® Dressings in Acute Wound Management (Only)"
NCT ID: NCT02237118
Last Updated: 2017-04-10
Study Results
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View full resultsBasic Information
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COMPLETED
NA
123 participants
INTERVENTIONAL
2014-09-30
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Mepitel One
Pain on dressing removal, by VAS
Mepitel One
UrgoTul
UrgoTul
Pain on removal by VAS
Mepitel One
UrgoTul
Interventions
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Mepitel One
UrgoTul
Eligibility Criteria
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Inclusion Criteria
2. Acute wound size between 3 cm² and 240 cm2 (wound could be covered by 2 investigational products maximum)
3. Wound whose duration is ≤ 3 days
4. Both gender with an age ≥ 18 years
5. Subject able to understand and voluntarily sign the informed consent
6. Subject able to follow the protocol
7. Subject insured to the French social security system
Exclusion Criteria
2. Infected, moderately to strongly exudative and haemorrhagic wound
3. Diagnosed underlying disease (e.g. diabetic neuropathy, stroke, …) which, as judged by the investigator, could interfere with the pain assessment
4. Known allergy/hypersensitivity to any of the components of the investigational products
5. Participation in other clinical investigation within one month prior to start of investigation
6. Pregnant or breast-feeding women
7. Person protected by a legal regime (tutorship or guardianship)
18 Years
ALL
No
Sponsors
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Molnlycke Health Care AB
INDUSTRY
Responsible Party
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Principal Investigators
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Anna Solanilla, Dr
Role: PRINCIPAL_INVESTIGATOR
Clinique Mutualiste du Medoc
Locations
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Clinique Mutualiste du Medoc
Lespare, , France
Countries
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Other Identifiers
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MPTO 05
Identifier Type: -
Identifier Source: org_study_id
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