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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2014-01-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Wounds and Injuries Abrasion Cut Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MySkin patch

Hydrogel and polyurethane film

Group Type EXPERIMENTAL

MySkin patch

Intervention Type DEVICE

Hydrogel and polyurethane film

Traditional Dressing

Group Type ACTIVE_COMPARATOR

Gauze and Patch

Intervention Type DEVICE

Traditional Dressing

Interventions

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MySkin patch

Hydrogel and polyurethane film

Intervention Type DEVICE

Gauze and Patch

Traditional Dressing

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No