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

December 20, 2011
January 10, 2014
January 2012
September 2014   (final data collection date for primary outcome measure)
Wound healing and Significant reduction in pain [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01499264 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Efficacy of MySkin Patch for the Healing of Burn Wounds: a Randomised Controlled Trial
Efficacy of MySkin Patch for the Healing of Burn Wounds: a Randomised Controlled Trial

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Burns
  • Burn Injury
  • Hydrogel Bandage
  • Occlusive Dressings
  • Device: MySkin patch
    Hydrogel and polyurethane film
  • Device: Traditional Dressing
    Gauze and Patch
  • Experimental: MySkin patch
    Hydrogel e polyurethane film
    Intervention: Device: MySkin patch
  • Active Comparator: Traditional Dressing
    Intervention: Device: Traditional Dressing
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
October 2014
September 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Angela Peghetti 3401848409 angela.peghetti@aosp.bo.it
Italy
 
NCT01499264
AISLeC-002
Yes
Associazione Infermieristica per lo studio delle Lesioni Cutanee
Associazione Infermieristica per lo studio delle Lesioni Cutanee
ARTSANA S.P.A.
Study Director: Patrizia Tomasin Associazione Infermieristica per lo studio delle Lesioni Cutanee
Associazione Infermieristica per lo studio delle Lesioni Cutanee
January 2014

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