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

This study is currently recruiting participants.
Verified January 2014 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: January 10, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Burns
Burn Injury
Hydrogel Bandage
Occlusive Dressings
Device: MySkin patch
Device: Traditional Dressing
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of MySkin Patch for the Healing of Burn Wounds: a Randomised Controlled Trial

Resource links provided by NLM:


Further study details as provided by Associazione Infermieristica per lo studio delle Lesioni Cutanee:

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

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 120
Study Start Date: January 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MySkin patch
Hydrogel e polyurethane film
Device: MySkin patch
Hydrogel and polyurethane film
Active Comparator: Traditional Dressing Device: Traditional Dressing
Gauze and Patch

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01499264

Contacts
Contact: Angela Peghetti 3401848409 angela.peghetti@aosp.bo.it

Locations
Italy
Istituto Clinico Humanitas - IRCCS Recruiting
Rozzano, Milano, Italy
Contact: Tomasin Patrizia       segreteria@aislec.it   
Ospedale di Circolo di Busto Arsizio Recruiting
Busto Arsizio, Varese, Italy
Contact: Luisa Pinelli, Nurse    340 1848409    segreteria@aislec.it   
Sponsors and Collaborators
Associazione Infermieristica per lo studio delle Lesioni Cutanee
ARTSANA S.P.A.
Investigators
Study Director: Patrizia Tomasin Associazione Infermieristica per lo studio delle Lesioni Cutanee
  More Information

No publications provided

Responsible Party: Associazione Infermieristica per lo studio delle Lesioni Cutanee
ClinicalTrials.gov Identifier: NCT01499264     History of Changes
Other Study ID Numbers: AISLeC-002
Study First Received: December 20, 2011
Last Updated: January 10, 2014
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by Associazione Infermieristica per lo studio delle Lesioni Cutanee:
MySkin patch

Additional relevant MeSH terms:
Burns
Wounds and Injuries

ClinicalTrials.gov processed this record on April 20, 2014