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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01499264
Other study ID # AISLeC-002
Secondary ID
Status Recruiting
Phase Phase 3
First received December 20, 2011
Last updated January 10, 2014
Start date January 2012
Est. completion date October 2014

Study information

Verified date January 2014
Source Associazione Infermieristica per lo studio delle Lesioni Cutanee
Contact Angela Peghetti
Phone 3401848409
Email angela.peghetti@aosp.bo.it
Is FDA regulated No
Health authority Italy: The Italian Medicines Agency
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date October 2014
Est. primary completion date September 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
MySkin patch
Hydrogel and polyurethane film
Traditional Dressing
Gauze and Patch

Locations

Country Name City State
Italy Ospedale di Circolo di Busto Arsizio Busto Arsizio Varese
Italy Istituto Clinico Humanitas - IRCCS Rozzano Milano

Sponsors (2)

Lead Sponsor Collaborator
Associazione Infermieristica per lo studio delle Lesioni Cutanee Artsana S.p.a.

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Wound healing and Significant reduction in pain 1 month No
Secondary Clinical evaluation of the lesion scores for each visit, the presence / absence of infection for each visit 1 month No
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