Prospective, Randomized, Non-inferiority Investigation to Compare Effects of Mepitel® One and UrgoTul® Dressings in Acute Wound Management (Only)

Study Overview
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Brief Summary
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To compare the effects of pain of the two dressings, Mepitel® One and UrgoTul® in acute wound management.

Official Title
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Prospective, Randomized, Non-inferiority Investigation to Compare Effects of Mepitel® One and UrgoTul® Dressings in Acute Wound Management (Only)

Conditions
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Pain

Intervention / Treatment
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* Device: Mepitel One
* Device: UrgoTul


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mepitel One<br>Pain on dressing removal, by VAS | Device: Mepitel One<br> <br> Device: UrgoTul<br> <br> |
| Active Comparator: UrgoTul<br>Pain on removal by VAS | Device: Mepitel One<br> <br> Device: UrgoTul<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Non-Painful Dressing Removal, Measured by Visual Aanalog Scale (VAS) | To compare the effects of pain of the two dressings, Mepitel® One and UrgoTul®, during the first dressing removal. Pain measured by VAS Score ≥ 30 mm on the 100 mm VAS scale are reported. | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete Healing at Day 21, Will be Measured Using PictZar ( Digital Planimetric System) System. | Complete healing at day 21, will be measured using PictZar system. | 21 days | 
| Condition of the Wound, Will be Assesst by the Investigator. | wound size estimation, assesstemnt of the wound, | 21 days | 
| Safety | Adverse Event, Adverse Device Event | 21 days | 
| Assessment of the Surrounding Skin. | assessment of the surrounding skin. | 21 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute, wound, management, measured, Visual analoge scale