Status:
UNKNOWN
Efficacy of MySkin Patch for the Healing of Burn Wounds: a Randomised Controlled Trial
Lead Sponsor:
Associazione Infermieristica per lo studio delle Lesioni Cutanee
Collaborating Sponsors:
Artsana S.p.a.
Conditions:
Burns
Burn Injury
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 reepit...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2014
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01499264
Start Date
January 1 2012
End Date
October 1 2014
Last Update
January 13 2014
Active Locations (2)
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1
Istituto Clinico Humanitas - IRCCS
Rozzano, Milano, Italy
2
Ospedale di Circolo di Busto Arsizio
Busto Arsizio, Varese, Italy