Lomatuell Pro® Versus UrgoTul® in the Management of Acute Wounds (SLALOM)

Lohmann & Rauscher (L&R)

Status: Completed

Conditions: Acute Wounds

Treatments: Device: UrgoTul; Device: Lomatuell Pro

Study type: Interventional

Funder types: Industry

Identifiers

NCT03897465

2018-A02288-47

Details and patient eligibility

About

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

Full description

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

Enrollment: 183 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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183 participants in 2 patient groups

Lomatuell Pro

Experimental group

Description:

Lomatuell Pro® is a wound contact layer consisting of wide-meshed tulle, impregnated with a polymer matrix, which form a gel on contact with wound exudate to facilitate moist wound healing.

Treatment:

Device: Lomatuell Pro

UrgoTul

Active Comparator group

Description:

UrgoTul® is a flexible contact layer with TLC (Technology Lipido-Colloid) healing matrix comprised of a conformable polyester mesh impregnated with hydrocolloid and petroleum jelly particles.

Treatment:

Device: UrgoTul