Efficacy of MySkin Patch for the Healing of Burn Wounds:... | NCT01499264

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

NCT01499264

Sponsor

Associazione Infermieristica per lo studio delle Lesioni Cutanee

Status

Unknown status

Last Update Posted

Jan 13, 2014Estimated

Enrollment

120Estimated

Phase

Phase 3

Conditions

Burns
Burn Injury
Hydrogel Bandage
Occlusive Dressings

Interventions

MySkin patch
Traditional Dressing

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Sep 2014Estimated

Completion Date

Oct 2014Estimated

First Submitted Date

Dec 20, 2011

First Submission Date that Met QC Criteria

Dec 22, 2011

First Posted Date

Dec 26, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 10, 2014

Last Update Posted Date

Jan 13, 2014Estimated

Name	Class
Artsana S.p.a.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MySkin patch	Experimental	Hydrogel e polyurethane film	Device: MySkin patch
Traditional Dressing	Active Comparator		Device: Traditional Dressing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MySkin patch	Device	Hydrogel and polyurethane film	MySkin patch
Traditional Dressing

Measure	Description	Time Frame
Wound healing and Significant reduction in pain		1 month

Measure	Description	Time Frame
Clinical evaluation of the lesion scores for each visit, the presence / absence of infection for each visit		1 month

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Angela Peghetti	Contact	3401848409		angela.peghetti@aosp.bo.it

Overall Officials

Name	Affiliation	Role
Patrizia Tomasin	Associazione Infermieristica per lo studio delle Lesioni Cutanee	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Istituto Clinico Humanitas - IRCCS	Recruiting	Rozzano	Milano		Italy