Efficacy of MySkin Patch for the Healing of Burn Wounds: a Randomised Controlled Trial
NCT ID: NCT01499264
Last Updated: 2014-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
120 participants
INTERVENTIONAL
2012-01-31
2014-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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MySkin patch
Hydrogel e polyurethane film
MySkin patch
Hydrogel and polyurethane film
Traditional Dressing
Traditional Dressing
Gauze and Patch
Interventions
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MySkin patch
Hydrogel and polyurethane film
Traditional Dressing
Gauze and Patch
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Artsana S.p.a.
INDUSTRY
Associazione Infermieristica per lo studio delle Lesioni Cutanee
OTHER
Responsible Party
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Principal Investigators
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Patrizia Tomasin
Role: STUDY_DIRECTOR
Associazione Infermieristica per lo studio delle Lesioni Cutanee
Locations
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Istituto Clinico Humanitas - IRCCS
Rozzano, Milano, Italy
Ospedale di Circolo di Busto Arsizio
Busto Arsizio, Varese, Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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AISLeC-002
Identifier Type: -
Identifier Source: org_study_id
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