Efficacy of MySkin Patch for the Healing of Burn Wounds: a Randomised Controlled Trial
This study is currently recruiting participants.
Verified December 2011 by Associazione Infermieristica per lo studio delle Lesioni Cutanee
Sponsor:
Associazione Infermieristica per lo studio delle Lesioni Cutanee
Collaborator:
ARTSANA S.P.A.
Information provided by (Responsible Party):
Associazione Infermieristica per lo studio delle Lesioni Cutanee
ClinicalTrials.gov Identifier:
NCT01499264
First received: December 20, 2011
Last updated: November 6, 2012
Last verified: December 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Burns Burn Injury Hydrogel Bandage Occlusive Dressings |
Device: MySkin patch Device: Traditional Dressing |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Efficacy of MySkin Patch for the Healing of Burn Wounds: a Randomised Controlled Trial |
Resource links provided by NLM:
Further study details as provided by Associazione Infermieristica per lo studio delle Lesioni Cutanee:
Primary Outcome Measures:
- Wound healing and Significant reduction in pain [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Clinical evaluation of the lesion scores for each visit, the presence / absence of infection for each visit [ Time Frame: 1 month ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 120 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: MySkin patch
Hydrogel e polyurethane film
|
Device: MySkin patch
Hydrogel and polyurethane film
|
| Active Comparator: Traditional Dressing |
Device: Traditional Dressing
Gauze and Patch
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01499264
Contacts
| Contact: Angela Peghetti | 3401848409 | angela.peghetti@aosp.bo.it |
Locations
| Italy | |
| Istituto Clinico Humanitas - IRCCS | Recruiting |
| Rozzano, Milano, Italy | |
| Contact: Tomasin Patrizia segreteria@aislec.it | |
| Ospedale di Circolo di Busto Arsizio | Recruiting |
| Busto Arsizio, Varese, Italy | |
| Contact: Luisa Pinelli, Nurse 340 1848409 segreteria@aislec.it | |
Sponsors and Collaborators
Associazione Infermieristica per lo studio delle Lesioni Cutanee
ARTSANA S.P.A.
Investigators
| Study Director: | Patrizia Tomasin | Associazione Infermieristica per lo studio delle Lesioni Cutanee |
More Information
No publications provided
| Responsible Party: | Associazione Infermieristica per lo studio delle Lesioni Cutanee |
| ClinicalTrials.gov Identifier: | NCT01499264 History of Changes |
| Other Study ID Numbers: | AISLeC-002 |
| Study First Received: | December 20, 2011 |
| Last Updated: | November 6, 2012 |
| Health Authority: | Italy: The Italian Medicines Agency |
Keywords provided by Associazione Infermieristica per lo studio delle Lesioni Cutanee:
|
MySkin patch |
Additional relevant MeSH terms:
|
Burns Wounds and Injuries |
ClinicalTrials.gov processed this record on May 16, 2013