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

NCT01499264 | Unknown Phase 3 DMC

• 1 other identifier: AISLeC-002
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

Burns; Burn Injury; Hydrogel Bandage; Occlusive Dressings

Keywords

MySkin patch

Outcome Measures

Primary Outcomes (1)

• Wound healing and Significant reduction in pain

  1 month

Secondary Outcomes (1)

• Clinical evaluation of the lesion scores for each visit, the presence / absence of infection for each visit

  1 month

Study Arms (2)

MySkin patch

EXPERIMENTAL

Hydrogel e polyurethane film

Device: MySkin patch

Traditional Dressing

ACTIVE COMPARATOR

Device: Traditional Dressing

Interventions

MySkin patch DEVICE

Hydrogel and polyurethane film

MySkin patch

Traditional Dressing DEVICE

Gauze and Patch

Traditional Dressing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Associazione Infermieristica per lo studio delle Lesioni Cutanee: lead
• Artsana S.p.a.: collaborator

Study Sites (2)

Istituto Clinico Humanitas - IRCCS

Rozzano, Milano, Italy

RECRUITING

Ospedale di Circolo di Busto Arsizio

Busto Arsizio, Varese, Italy

RECRUITING

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Patrizia Tomasin

  Associazione Infermieristica per lo studio delle Lesioni Cutanee

  STUDY DIRECTOR

Central Study Contacts

Angela Peghetti

CONTACT

3401848409; angela.peghetti@aosp.bo.it

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2011
• First Posted: December 26, 2011
• Study Start: January 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: October 1, 2014
• Last Updated: January 13, 2014

Record last verified: 2014-01

Locations

IT (2)