Efficacy of MySkin Patch for the Healing of Cut Injuries and Abrasions

This study has been completed.
Sponsor:
Collaborator:
ARTSANA S.P.A.
Information provided by (Responsible Party):
Associazione Infermieristica per lo studio delle Lesioni Cutanee
ClinicalTrials.gov Identifier:
NCT01573234
First received: April 2, 2012
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 cut injuries and abrasions with particular regard to: Wound healing (complete reepithelialization) and 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 Pressure Sore Status Tool(PSST).


Condition Intervention Phase
Wounds and Injuries
Abrasion
Cut Injuries
Device: MySkin patch
Device: Gauze and Patch
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 Cut Injuries and Abrasions: 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 [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Patient's pain [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical evaluation of the lesion scores for each visit [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • The presence / absence of infection for each visit [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Enrollment: 180
Study Start Date: April 2012
Study Completion Date: January 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MySkin patch
Hydrogel and polyurethane film
Device: MySkin patch
Hydrogel and polyurethane film
Active Comparator: Traditional Dressing Device: Gauze and Patch
Traditional Dressing

  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 an injury cut or abrasion (even if sutured)covered by a dressing of 10x8 cm (80 cm2)
  • Injury treated with conventional dressings type gauze and patch
  • 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 (wash-out) of "no treatment" according to the research protocol

Exclusion Criteria:

  • A end-stage of disease
  • Subjected systemic corticosteroid therapy / radiotherapy / immunosuppressive therapy
  • 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 (wash-out) of suspension from the same research protocol
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01573234

Locations
Italy
Ospedale Bellaria - UOC Dermatologia
Bologna, Italy, 40100
Sponsors and Collaborators
Associazione Infermieristica per lo studio delle Lesioni Cutanee
ARTSANA S.P.A.
Investigators
Study Director: Tommaso Bianchi 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: NCT01573234     History of Changes
Other Study ID Numbers: AISLeC-003
Study First Received: April 2, 2012
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
Hydrogel bandage
Occlusive dressing

Additional relevant MeSH terms:
Wounds and Injuries

ClinicalTrials.gov processed this record on April 17, 2014