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

Burns Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01499264
• Other study ID #: AISLeC-002
• Status: Recruiting
• Phase: Phase 3
• First received: December 20, 2011
• Last updated: January 10, 2014
• Start date: January 2012
• Est. completion date: October 2014

Study information

• Verified date: January 2014
• Source: Associazione Infermieristica per lo studio delle Lesioni Cutanee
• Contact: Angela Peghetti
• Phone: 3401848409
• Email: angela.peghetti[@]aosp.bo.it
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: October 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Burn Injury
• Burns
• Hydrogel Bandage
• Occlusive Dressings

Intervention

Device:
• MySkin patch
Hydrogel and polyurethane film
• Traditional Dressing
Gauze and Patch

Locations

Country	Name	City	State
Italy	Ospedale di Circolo di Busto Arsizio	Busto Arsizio	Varese
Italy	Istituto Clinico Humanitas - IRCCS	Rozzano	Milano

Sponsors (2)

Lead Sponsor	Collaborator
Associazione Infermieristica per lo studio delle Lesioni Cutanee	Artsana S.p.a.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound healing and Significant reduction in pain		1 month	No
Secondary	Clinical evaluation of the lesion scores for each visit, the presence / absence of infection for each visit		1 month	No