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

This study is currently recruiting participants.

Verified December 2011 by Associazione Infermieristica per lo studio delle Lesioni Cutanee

Sponsor:

Collaborator:

ARTSANA S.P.A.

Information provided by (Responsible Party):

Associazione Infermieristica per lo studio delle Lesioni Cutanee

ClinicalTrials.gov Identifier:

NCT01499264

First received: December 20, 2011

Last updated: November 6, 2012

Last verified: December 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

December 20, 2011

Last Updated Date

November 6, 2012

Start Date ^ICMJE

January 2012

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Wound healing and Significant reduction in pain [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01499264 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Clinical evaluation of the lesion scores for each visit, the presence / absence of infection for each visit [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 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

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Burns
Burn Injury
Hydrogel Bandage
Occlusive Dressings

Intervention ^ICMJE

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

Study Arm (s)

Experimental: MySkin patch
Hydrogel e polyurethane film

Intervention: Device: MySkin patch
Active Comparator: Traditional Dressing
Intervention: Device: Traditional Dressing

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

120

Estimated Completion Date

December 2013

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Angela Peghetti

3401848409

angela.peghetti@aosp.bo.it

Location Countries ^ICMJE

Italy

Administrative Information

NCT Number ^ICMJE

NCT01499264

Other Study ID Numbers ^ICMJE

AISLeC-002

Has Data Monitoring Committee

Yes

Responsible Party

Associazione Infermieristica per lo studio delle Lesioni Cutanee

Study Sponsor ^ICMJE

Associazione Infermieristica per lo studio delle Lesioni Cutanee

Collaborators ^ICMJE

ARTSANA S.P.A.

Investigators ^ICMJE

Study Director:

Patrizia Tomasin

Associazione Infermieristica per lo studio delle Lesioni Cutanee

Information Provided By

Associazione Infermieristica per lo studio delle Lesioni Cutanee

Verification Date

December 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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