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

Efficacy of MySkin Patch for the Healing of Cut Injuries and Abrasions: a Randomised Controlled Trial

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).

Study Overview

• Status: Completed
• Conditions: Wounds and Injuries; Abrasion; Cut Injuries
• Intervention / Treatment: Device: MySkin patch; Device: Gauze and Patch

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • Bologna, Italy, 40100
    • Ospedale Bellaria - UOC Dermatologia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: MySkin patch; Hydrogel and polyurethane film	Device: MySkin patch; Hydrogel and polyurethane film
ACTIVE_COMPARATOR: Traditional Dressing	Device: Gauze and Patch; Traditional Dressing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Wound healing	1 month
Patient's pain	1 month

Secondary Outcome Measures

Outcome Measure	Time Frame
Clinical evaluation of the lesion scores for each visit	1 month
The presence / absence of infection for each visit	1 month

Collaborators and Investigators

• Sponsor: Associazione Infermieristica per lo studio delle Lesioni Cutanee
• Collaborators: Artsana S.p.a.
• Investigators: Study Director: Tommaso Bianchi, Associazione Infermieristica per lo studio delle Lesioni Cutanee

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (ACTUAL): December 1, 2013
• Study Completion (ACTUAL): January 1, 2014

Study Registration Dates

• First Submitted: April 2, 2012
• First Submitted That Met QC Criteria: April 6, 2012
• First Posted (ESTIMATE): April 9, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): January 13, 2014
• Last Update Submitted That Met QC Criteria: January 10, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: MySkin patch; Hydrogel bandage; Occlusive dressing
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: AISLeC-003