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

Associazione Infermieristica per lo studio delle Lesioni Cutanee

Status and phase: Unknown; Phase 3

Conditions: Occlusive Dressings; Hydrogel Bandage; Burns; Burn Injury

Treatments: Device: Traditional Dressing; Device: MySkin patch

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01499264

AISLeC-002

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

MySkin patch

Experimental group

Description:

Hydrogel e polyurethane film

Treatment:

Device: MySkin patch

Traditional Dressing

Active Comparator group

Treatment:

Device: Traditional Dressing