BurnsPhase 3NCT01499264
Efficacy of MySkin Patch for the Healing of Burn Wounds: a Randomised Controlled Trial
A Phase 3 study testing MySkin patch and Traditional Dressing in people with Burns and Burn Injury, run by Associazione Infermieristica per lo studio delle Lesioni Cutanee at 2 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burns, Burn Injury, Hydrogel Bandage
- What is being tested?
- MySkin patch and Traditional Dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesItaly
- Study dates
- Jan 2012to Oct 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Recruiting
Ospedale di Circolo di Busto Arsizio
Busto Arsizio, Varese
Luisa Pinelli, Nurse, 340 1848409, segreteria@aislec.it
- Recruiting
Istituto Clinico Humanitas - IRCCS
Rozzano, Milano
Tomasin Patrizia, segreteria@aislec.it
About this study
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
- Being tested
- MySkin patch, Traditional Dressing
- Keywords
- MySkin patch
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MySkin patchDevice
Hydrogel and polyurethane film
Traditional DressingDevice
Gauze and Patch
| Study group | Role | What they receive |
|---|---|---|
| MySkin patch | Experimental | Hydrogel e polyurethane film Receives: Device: MySkin patch |
| Traditional Dressing | Active comparator | Not described Receives: Device: Traditional Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound healing and Significant reduction in pain
Measured: 1 month
Secondary outcomes (1)
Clinical evaluation of the lesion scores for each visit, the presence / absence of infection for each visit
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionSep 2014 (estimated)
- Study completionOct 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Associazione Infermieristica per lo studio delle Lesioni Cutanee
- Sponsor type
- University, hospital or other
- Collaborators
- Artsana S.p.a.
- Responsible party
- Sponsor
- Investigators
- Patrizia Tomasin, Study director, Associazione Infermieristica per lo studio delle Lesioni Cutanee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01499264
- Sponsor's protocol ID
- AISLeC-002
- Status last verified
- Jan 2014
- First submitted
- 20 Dec 2011
- Last updated
- 13 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of MySkin Patch for the Healing of Burn Wounds: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT01499264
- Acronym / sponsor ID
- AISLeC-002
- Conditions
- Burns, Burn Injury, Hydrogel Bandage, Occlusive Dressings
- Keywords
- MySkin patch
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Associazione Infermieristica per lo studio delle Lesioni CutaneeUniversity, hospital or other
- Collaborators
- Artsana S.p.a.
- Study start
- Jan 2012
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 26 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MySkin patch | Experimental | Device: MySkin patchHydrogel e polyurethane film |
| Traditional Dressing | Active comparator | Device: Traditional Dressing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MySkin patchHydrogel and polyurethane film | Device | MySkin patch |
| Traditional DressingGauze and Patch | Device | Traditional Dressing |
Primary outcome
Wound healing and Significant reduction in pain
Time frame: 1 month
1 secondary outcome
Clinical evaluation of the lesion scores for each visit, the presence / absence of infection for each visit
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrizia Tomasin study director
Associazione Infermieristica per lo studio delle Lesioni Cutanee
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MySkin patch and Traditional Dressing in people with Burns and Burn Injury, run by Associazione Infermieristica per lo studio delle Lesioni Cutanee at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Angela Peghetti (3401848409, angela.peghetti@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound healing and Significant reduction in pain (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2014; AzTrials last refreshed its copy on 8 Nov 2026.