Efficacy of MySkin Patch for the Healing of Cut Injuries and Abrasions
Primary Purpose
Wounds and Injuries, Abrasion, Cut Injuries
Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
MySkin patch
Gauze and Patch
Sponsored by
About this trial
This is an interventional treatment trial for Wounds and Injuries focused on measuring MySkin patch, Hydrogel bandage, Occlusive dressing
Eligibility 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
Sites / Locations
- Ospedale Bellaria - UOC Dermatologia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
MySkin patch
Traditional Dressing
Arm Description
Hydrogel and polyurethane film
Outcomes
Primary Outcome Measures
Wound healing
Patient's 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
NCT01573234
First Posted
April 2, 2012
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
NCT01573234
Brief Title
Efficacy of MySkin Patch for the Healing of Cut Injuries and Abrasions
Official Title
Efficacy of MySkin Patch for the Healing of Cut Injuries and Abrasions: a Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
January 2014 (Actual)
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 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wounds and Injuries, Abrasion, Cut Injuries
Keywords
MySkin patch, Hydrogel bandage, Occlusive dressing
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MySkin patch
Arm Type
Experimental
Arm Description
Hydrogel and 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)
Gauze and Patch
Intervention Description
Traditional Dressing
Primary Outcome Measure Information:
Title
Wound healing
Time Frame
1 month
Title
Patient's pain
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Clinical evaluation of the lesion scores for each visit
Time Frame
1 month
Title
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
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tommaso Bianchi
Organizational Affiliation
Associazione Infermieristica per lo studio delle Lesioni Cutanee
Official's Role
Study Director
Facility Information:
Facility Name
Ospedale Bellaria - UOC Dermatologia
City
Bologna
ZIP/Postal Code
40100
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Efficacy of MySkin Patch for the Healing of Cut Injuries and Abrasions
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