Efficacy of MySkin Patch for the Healing of Burn Wounds: a Randomised Controlled Trial

Study Overview
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Brief Summary
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Evaluation of clinical efficacy of my skin (hydrogel and polyurethane film) plus best practice clinical care in subjects with burn injuries with particular regard to: 1) Wound healing (complete reepithelialization), 2) the patient's pain. In the context of the study will be collected secondary outcomes related to type of lesion and its clinical evolution through the analysis of the items in the scale of the PSST.

Official Title
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Efficacy of MySkin Patch for the Healing of Burn Wounds: a Randomised Controlled Trial

Conditions
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Burn Injury, Burns, Hydrogel Bandage, Occlusive Dressings

Intervention / Treatment
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* Device: MySkin patch
* Device: Traditional Dressing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presence of at least one injury burn covered by a dressing of 10x8 cm (80 cm2) Injury treated with medication in use at the center Patients assisted at the emergency care, or at the outpatient Extension of the lesion less than 80 cm2 (including dressings in cm10x8cm) Patient age greater than or equal to 18 years Patients who have given consent to enrollment in the trial and the processing of personal data Patient / lesion that has already been recruited in the study or who have previously passed a period of 10 days (washout) of no treatment according to the research protocol Exclusion Criteria: A end-stage of disease Suspected or known allergic diathesis to the product of medication Subjects that do not give consent to data processing Dry lesion with necrosis or eschar Presence of both local and systemic infection or inflammation Injuries that to the decision of the provider of care, needs a targeted local treatment other than as provided for in the Protocol Patient / lesion that has already been previously recruited into the study, before a period of 10 days (washout) of suspension from the same research protocol Patients who use alternative medicine treatments such as aloe

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 |
| --- | --- |
| Experimental: MySkin patch<br>Hydrogel e polyurethane film | Device: MySkin patch<br>* Hydrogel and polyurethane film<br>|
| Active Comparator: Traditional Dressing<br> | Device: Traditional Dressing<br>* Gauze and Patch<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound healing and Significant reduction in pain |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical evaluation of the lesion scores for each visit, the presence / absence of infection for each visit |  | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MySkin patch