Efficacy of MySkin Patch for the Healing of Burn Wounds: a Randomised Controlled Trial

NCT ID: NCT01499264

Last Updated: 2014-01-13

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2014-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Burns Burn Injury Hydrogel Bandage Occlusive Dressings

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MySkin patch

Hydrogel e polyurethane film

Group Type EXPERIMENTAL

MySkin patch

Intervention Type DEVICE

Hydrogel and polyurethane film

Traditional Dressing

Group Type ACTIVE_COMPARATOR

Traditional Dressing

Intervention Type DEVICE

Gauze and Patch

Interventions

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MySkin patch

Hydrogel and polyurethane film

Intervention Type DEVICE

Traditional Dressing

Gauze and Patch

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Artsana S.p.a.

INDUSTRY

Sponsor Role collaborator

Associazione Infermieristica per lo studio delle Lesioni Cutanee

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Ospedale di Circolo di Busto Arsizio

Busto Arsizio, Varese, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Angela Peghetti

Role: CONTACT

3401848409

Facility Contacts

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Tomasin Patrizia

Role: primary

Luisa Pinelli, Nurse

Role: primary

340 1848409

Other Identifiers

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AISLeC-002

Identifier Type: -

Identifier Source: org_study_id

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