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

January 10, 2014 updated by: Associazione Infermieristica per lo studio delle Lesioni Cutanee
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • Milano
      • Rozzano, Milano, Italy
        • Recruiting
        • Istituto Clinico Humanitas - IRCCS
        • Contact:
    • Varese
      • Busto Arsizio, Varese, Italy
        • Recruiting
        • Ospedale di Circolo di Busto Arsizio
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MySkin patch
Hydrogel e polyurethane film
Device: MySkin patch
Hydrogel and polyurethane film
Active Comparator: Traditional Dressing
Device: Traditional Dressing
Gauze and Patch

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Associazione Infermieristica per lo studio delle Lesioni Cutanee

Collaborators

Artsana S.p.a.

Investigators

  • Study Director: Patrizia Tomasin, Associazione Infermieristica per lo studio delle Lesioni Cutanee

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Anticipated)

September 1, 2014

Study Completion (Anticipated)

October 1, 2014

Study Registration Dates

First Submitted

December 20, 2011

First Submitted That Met QC Criteria

December 22, 2011

First Posted (Estimate)

December 26, 2011

Study Record Updates

Last Update Posted (Estimate)

January 13, 2014

Last Update Submitted That Met QC Criteria

January 10, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AISLeC-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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