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

Phase 3

Completed

• Conditions: Wounds and Injuries; Abrasion; Cut Injuries
• Interventions: Device: MySkin patch; Device: Gauze and Patch

• Registration Number: NCT01573234
• Lead Sponsor: Associazione Infermieristica per lo studio delle Lesioni Cutanee

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-04-02
• Study First Submitted QC: 2012-04-06
• Study First Posted: 2012-04-09
• Primary Completion: 2013-12
• Status Verified: 2014-01
• Study Completion: 2014-01
• Last Update Submitted: 2014-01-10
• Last Update Posted: 2014-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MySkin patch	MySkin patch	Hydrogel and polyurethane film
Traditional Dressing	Gauze and Patch	-

Primary Outcome Measures

Name	Time	Method
Wound healing	1 month
Patient's pain	1 month

Secondary Outcome Measures

Name	Time	Method
Clinical evaluation of the lesion scores for each visit	1 month
The presence / absence of infection for each visit	1 month

Trial Locations

Locations (1)

Ospedale Bellaria - UOC Dermatologia; 🇮🇹 Bologna, Italy