Status:
COMPLETED
Prospective, Randomized, Non-inferiority Investigation to Compare Effects of Mepitel® One and UrgoTul® Dressings in Acute Wound Management (Only)"
Lead Sponsor:
Molnlycke Health Care AB
Conditions:
Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To compare the effects of pain of the two dressings, Mepitel® One and UrgoTul® in acute wound management.
Eligibility Criteria
Inclusion
- Acute wound: traumatic wound (dermabrasion, skin tears, other), benign burn requiring the use of dressings
- Acute wound size between 3 cm² and 240 cm2 (wound could be covered by 2 investigational products maximum)
- Wound whose duration is ≤ 3 days
- Both gender with an age ≥ 18 years
- Subject able to understand and voluntarily sign the informed consent
- Subject able to follow the protocol
- Subject insured to the French social security system
Exclusion
- Surgical wound
- Infected, moderately to strongly exudative and haemorrhagic wound
- Diagnosed underlying disease (e.g. diabetic neuropathy, stroke, …) which, as judged by the investigator, could interfere with the pain assessment
- Known allergy/hypersensitivity to any of the components of the investigational products
- Participation in other clinical investigation within one month prior to start of investigation
- Pregnant or breast-feeding women
- Person protected by a legal regime (tutorship or guardianship)
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
123 Patients enrolled
Trial Details
Trial ID
NCT02237118
Start Date
September 1 2014
End Date
December 1 2015
Last Update
April 10 2017
Active Locations (1)
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1
Clinique Mutualiste du Medoc
Lespare, France, 33340