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

Not Applicable

Completed

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

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

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Lomatuell Pro	Lomatuell Pro	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.
UrgoTul	UrgoTul	UrgoTul® is a flexible contact layer with TLC healing matrix comprised of a conformable polyester mesh impregnated with hydrocolloid and petroleum jelly particles.

Primary Outcome Measures

Name	Time	Method
Percentage of Wound Dressing Changes Associated With a Pain <30 mm on Visual Analog Scale (VAS)	At Visit 2 (Day 3 ± 2 days)	To evaluate the main study objective, patients were asked to assess the pain they felt during the first dressing removal (D3±2 days) with a means of visual analog scale (VAS), a 100 mm straight line ranging from 0 to 100, where "0" refers to "no pain" and "100" to the "worst pain imaginable". The VAS score was directly measured by the investigator with a scale in millimetres and the number was entered in the patient's case report from (CRF).

Secondary Outcome Measures

Name	Time	Method
Complete Healing	At Visit 3 (Day 21 or earlier, as soon as the wound is epithelialized)	Percentage of epithelialization of the wound at V3 calculated based on a blind assessment of wound photographs using W.H.A.T. assessment (W.H.A.T. = Wound Healing Analysing Tool is a program for assessment of the wound photos, which allows to obtain automatically-calculated results for wound area, wound dimensions, % of necrotic, granulation or epithelium tissues in the wound bed). "Complete healing" was defined as 100% of the wound area covered by the epithelium.