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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

About this trial

This is an interventional treatment trial for Wounds and Injuries focused on measuring MySkin patch, Hydrogel bandage, Occlusive dressing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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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