Burns, Burn Injury, Hydrogel Bandage, Occlusive Dressings
Conditions
Keywords
MySkin patch
Brief summary
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.
Interventions
DEVICEMySkin patch
Hydrogel and polyurethane film
DEVICETraditional Dressing
Gauze and Patch
Sponsors
Artsana S.p.a.
Associazione Infermieristica per lo studio delle Lesioni Cutanee
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wound healing and Significant reduction in pain | 1 month |
Secondary
| Measure | Time frame |
|---|---|
| Clinical evaluation of the lesion scores for each visit, the presence / absence of infection for each visit | 1 month |
Countries
Italy
Contacts
Primary ContactAngela Peghetti
Outcome results
None listed