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

Primary Purpose

Burns, Burn Injury, Hydrogel Bandage

Status

Unknown status

Phase

Phase 3

Locations

Italy

Study Type

Interventional

Intervention

MySkin patch

Traditional Dressing

About this trial

This is an interventional treatment trial for Burns focused on measuring MySkin patch

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Istituto Clinico Humanitas - IRCCSRecruiting
Ospedale di Circolo di Busto ArsizioRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MySkin patch

Traditional Dressing

Arm Description

Hydrogel e polyurethane film

Outcomes

Primary Outcome Measures

Wound healing and Significant reduction in pain

Secondary Outcome Measures

Clinical evaluation of the lesion scores for each visit, the presence / absence of infection for each visit

Full Information

NCT ID

NCT01499264

First Posted

December 20, 2011

Last Updated

January 10, 2014

Sponsor

Associazione Infermieristica per lo studio delle Lesioni Cutanee

Collaborators

Artsana S.p.a.

1. Study Identification

Unique Protocol Identification Number

NCT01499264

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Unknown status

Study Start Date

January 2012 (undefined)

Primary Completion Date

September 2014 (Anticipated)

Study Completion Date

October 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Associazione Infermieristica per lo studio delle Lesioni Cutanee

Collaborators

Artsana S.p.a.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Burns, Burn Injury, Hydrogel Bandage, Occlusive Dressings

Keywords

MySkin patch

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

MySkin patch

Arm Type

Experimental

Arm Description

Hydrogel e polyurethane film

Arm Title

Traditional Dressing

Arm Type

Active Comparator

Intervention Type

Device

Intervention Name(s)

MySkin patch

Intervention Description

Hydrogel and polyurethane film

Intervention Type

Device

Intervention Name(s)

Traditional Dressing

Intervention Description

Gauze and Patch

Primary Outcome Measure Information:

Title

Wound healing and Significant reduction in pain

Time Frame

1 month

Secondary Outcome Measure Information:

Title

Clinical evaluation of the lesion scores for each visit, the presence / absence of infection for each visit

Time Frame

1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Angela Peghetti

Phone

3401848409

angela.peghetti@aosp.bo.it

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Patrizia Tomasin

Organizational Affiliation

Associazione Infermieristica per lo studio delle Lesioni Cutanee

Official's Role

Study Director

Facility Information:

Facility Name

Istituto Clinico Humanitas - IRCCS

City

Rozzano

State/Province

Milano

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tomasin Patrizia

segreteria@aislec.it

Facility Name

Ospedale di Circolo di Busto Arsizio

City

Busto Arsizio

State/Province

Varese

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Luisa Pinelli, Nurse

Phone

340 1848409

segreteria@aislec.it

12. IPD Sharing Statement

Learn more about this trial

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

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