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

Study Overview
=================
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.

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

Conditions
-----------------
Acute Wounds

Intervention / Treatment
-----------------
* Device: Lomatuell Pro
* Device: UrgoTul


Participation Criteria
=================
Eligibility Criteria
-----------------
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 tool Patient not covered by health insurance/social security

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lomatuell Pro<br>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. | Device: Lomatuell Pro<br>* Patients will receive Lomatuell Pro dressings during 3 weeks. Lomatuell Pro® may be left in place up to 7 days; additional dressing changes can be performed as often as necessary according to the instruction for use.<br>|
| Active Comparator: UrgoTul<br>UrgoTul® is a flexible contact layer with TLC healing matrix comprised of a conformable polyester mesh impregnated with hydrocolloid and petroleum jelly particles. | Device: UrgoTul<br>* Patients will receive UrgoTul dressings during 3 weeks. UrgoTul® may be left in place up to 7 days; ; additional dressing changes can be performed as often as necessary according to the instruction for use.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of wound dressing changes associated with a pain <30 mm on Visual Analog Scale (VAS) | A specific ruler will be provided to the investigator in order to measure the VAS score. The subject will mark on the ruler the point that he/she feels represent his/her perception of his/her current pain. The VAS score will be directly measured by the investigator with a scale in millimetres. The VAS score will be filled in the CRF. | At Visit 2 (Day 3 ± 2 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete healing: Percentage of epithelialization of the wound at V3 calculated based on a blind assessment from photographs using W.H.A.T. assessment |  | At Visit 3 (Day 21 or earlier, as soon as the wound is epithelialized) | 
| Condition of the wound | The wound bed condition will be evaluated regarding 6 condition items: bleeding, maceration, inflammation, infection, ratio necrotic/ fibrinous/ granulation/ epithelisation tissue, and tissue in-growth in the dressing holes, by means of the following 4-points scale: none, mild, moderate, severe. The percentage of each modality for each condition items will be calculated. | At Visit 2 (Day 3 ± 2 days) and Visit 3 (Day 21 or earlier, as soon as the wound is epithelialized) | 
| Condition of the surrounding skin | The condition of the surrounding skin will be assessed regarding different conditions: inflammatory signs, irritation, allergic rash/eczema, blistering, skin stripping, maceration, dry, trauma to wound edges, product degradation on the skin, hematoma, other. These condition items will be assessed by means of the scale Yes/No. The percentage of each modality will be calculated. | At Visit 2 (Day 3 ± 2 days) and Visit 3 (Day 21 or earlier, as soon as the wound is epithelialized) | 
| Global assessment of exudate management | This will use a Cochran-Mantel-Haenszel test including treatment groups and baseline wound exudation status (none, light and moderate/heavy). | At Visit 2 (Day 3 ± 2 days) and Visit 3 (Day 21 or earlier, as soon as the wound is epithelialized) | 
| Investigator's global assessment of the product | The global assessment of the dressing will be performed by the investigator regarding the following items: ease of handling, ability to maintain its integrity, ease of application, ability to be repositioned during application, conformability, wound adhesion, ability of dressings to stay in place, transparency, ability to transfer wound fluid to the secondary dressing, ease / speed of removal, overall impression, and absence of residue. Each item will be evaluated by means of the following scale: very good, good, poor, and very poor. The percentage of each modality will be presented. | At Visit 2 (Day 3 ± 2 days) and Visit 3 (Day 21 or earlier, as soon as the wound is epithelialized) | 
| Patient's global assessment of the product | The global assessment of the dressing will be performed by the subject regarding the following items: ability to maintain its integrity, ability of dressings to stay in place, transparency, comfort of the patient, ability to transfer wound fluid to the secondary dressing, ease/speed of removal, overall impression. Each item will be evaluated by means of the following scale: very good, good, moderate, poor, very poor. The percentage of each modality will be presented. | At Visit 3 (Day 21 or earlier, as soon as the wound is epithelialized) | 
| Safety endpoint: frequency and character of device deficiencies (DDs), adverse events (AEs), serious adverse events (SAEs), adverse device effects (ADEs), serious adverse device effects (SADEs) | Safety analyses will be descriptive overall and by dressing group. Any local and general adverse events occurring and those already present, but worsening, during the course of the investigation will be described on the safety population. Frequencies will be provided per dressing group and overall describing the type of event: device deficiency (DD), adverse event (AE), serious AE (SAE), adverse device effect (ADE), serious ADE | At Visit 2 (Day 3 ± 2 days) and Visit 3 (Day 21 or earlier, as soon as the wound is epithelialized) |