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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01573234
Other study ID # AISLeC-003
Secondary ID
Status Completed
Phase Phase 3
First received April 2, 2012
Last updated January 10, 2014
Start date April 2012
Est. completion date January 2014

Study information

Verified date January 2014
Source Associazione Infermieristica per lo studio delle Lesioni Cutanee
Contact n/a
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 cut injuries and abrasions with particular regard to: Wound healing (complete reepithelialization) and 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 Pressure Sore Status Tool(PSST).


Recruitment information / eligibility

Status Completed
Enrollment 180
Est. completion date January 2014
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Presence of at least an injury cut or abrasion (even if sutured)covered by a dressing of 10x8 cm (80 cm2)

- Injury treated with conventional dressings type gauze and patch

- 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 (wash-out) of "no treatment" according to the research protocol

Exclusion Criteria:

- A end-stage of disease

- Subjected systemic corticosteroid therapy / radiotherapy / immunosuppressive therapy

- 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 (wash-out) of suspension from the same research protocol

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
Gauze and Patch
Traditional Dressing

Locations

Country Name City State
Italy Ospedale Bellaria - UOC Dermatologia Bologna

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 1 month No
Primary Patient's pain 1 month No
Secondary Clinical evaluation of the lesion scores for each visit 1 month No
Secondary The presence / absence of infection for each visit 1 month No
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