Efficacy of MySkin Patch for the Healing of Burn Wounds: a Randomised Controlled Trial

Phase 3

• Conditions: Burns; Burn Injury; Hydrogel Bandage; Occlusive Dressings
• Interventions: Device: MySkin patch; Device: Traditional Dressing

• Registration Number: NCT01499264
• 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 burn injuries with particular regard to: 1) Wound healing (complete reepithelialization), 2) the 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 PSST.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-12-20
• Study First Submitted QC: 2011-12-22
• Study First Posted: 2011-12-26
• Study Start: 2012-01
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-10
• Last Update Posted: 2014-01-13
• Primary Completion: 2014-09
• Study Completion: 2014-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Presence of at least one injury burn covered by a dressing of 10x8 cm (80 cm2)
• Injury treated with medication in use at the center
• 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 (washout) of "no treatment" according to the research protocol

Exclusion Criteria

• A end-stage of disease
• 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 (washout) of suspension from the same research protocol
• Patients who use alternative medicine treatments such as aloe

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MySkin patch	MySkin patch	Hydrogel e polyurethane film
Traditional Dressing	Traditional Dressing	-

Primary Outcome Measures

Name	Time	Method
Wound healing and Significant reduction in pain	1 month

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Istituto Clinico Humanitas - IRCCS; 🇮🇹 Rozzano, Milano, Italy

Ospedale di Circolo di Busto Arsizio; 🇮🇹 Busto Arsizio, Varese, Italy