Lomatuell Pro® Versus UrgoTul® in the Management of Acute Wounds

Comparative Evaluation of the propertieS of the Contact LAyer Dressing LOMatuell Pro® Versus UrgoTul® in the Management of Acute Wounds

Comparative evaluation of the propertieS of the contact LAyer dressing LOMatuell Pro® versus UrgoTul® in the management of acute wounds

National, multicenter, prospective, randomized in parallel groups, non-inferiority, open-label investigation study.

Inclusion Criteria:

• Acute wound: traumatic wound (dermabrasion, skin tears, other), small burns 1st and 2nd degree requiring the use of dressings
• Acute wound size between 3 cm² and 24 cm² (wound could be covered by 2 investigational products maximum)
• Wound whose duration is ≤ 3 days
• Both gender with an age ≥ 18 years
• Written confirmation from the study nurse that the patient was informed, orally agreed to participate and to comply with study treatment and planned visits
• Subject able to follow the protocol

Exclusion Criteria:

• Chronic and acute surgical wound
• Infected, moderately to strongly exudative and haemorrhagic wound
• Diagnosed underlying disease (e.g. diabetic neuropathy, stroke, etc.) 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)
• Patients unable to manifest an oral consent to participate (e.g. dementia) or to understand the use of the VAS (visual analogue scale) tool
• Patient not covered by health insurance/social security