Wounds and InjuriesPhase 3NCT01573234
Efficacy of MySkin Patch for the Healing of Cut Injuries and Abrasions
A Phase 3 study testing MySkin patch and Gauze and Patch in people with Wounds and Injuries and Abrasion, run by Associazione Infermieristica per lo studio delle Lesioni Cutanee at 1 site in Italy.
Trial summary
Evaluation of clinical efficacy of My Skin (hydrogel and polyurethane film) plus best practice clinical care in subjects with cut injuries and abrasions with particular regard to: Wound healing (complete reepithelialization) and patient's pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wounds and Injuries, Abrasion, Cut Injuries
- What is being tested?
- MySkin patch and Gauze and Patch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2012to Jan 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 an injury cut or abrasion (even if sutured)covered by a dressing of 10x8 cm (80 cm2)
- Injury treated with conventional dressings type gauze and patch
- 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 (wash-out) of "no treatment" according to the research protocol
Who cannot join
- A end-stage of disease
- Subjected systemic corticosteroid therapy / radiotherapy / immunosuppressive therapy
- 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 (wash-out) of suspension from the same research protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of MySkin Patch for the Healing of Cut Injuries and Abrasions: a Randomised Controlled Trial
Evaluation of clinical efficacy of My Skin (hydrogel and polyurethane film) plus best practice clinical care in subjects with cut injuries and abrasions with particular regard to: Wound healing (complete reepithelialization) and 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 Pressure Sore Status Tool(PSST).
- Conditions
- Wounds and Injuries, Abrasion, Cut Injuries
- Being tested
- MySkin patch, Gauze and Patch
- Keywords
- MySkin patch, Hydrogel bandage, Occlusive dressing
- Medical subject headings
- Wounds and Injuries
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
Gauze and PatchDevice
Traditional Dressing
| Study group | Role | What they receive |
|---|---|---|
| MySkin patch | Experimental | Hydrogel and polyurethane film Receives: Device: MySkin patch |
| Traditional Dressing | Active comparator | Not described Receives: Device: Gauze and Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound healing
Measured: 1 month
Patient's pain
Measured: 1 month
Secondary outcomes (2)
Clinical evaluation of the lesion scores for each visit
Measured: 1 month
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 posted9 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionDec 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wounds and InjuriesStudies 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
- 180 participants (actual)
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
- Tommaso Bianchi, Study director, Associazione Infermieristica per lo studio delle Lesioni Cutanee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01573234
- Sponsor's protocol ID
- AISLeC-003
- Status last verified
- Jan 2014
- First submitted
- 2 Apr 2012
- 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 Cut Injuries and Abrasions: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT01573234
- Acronym / sponsor ID
- AISLeC-003
- Conditions
- Wounds and Injuries, Abrasion, Cut Injuries
- Keywords
- MySkin patch, Hydrogel bandage, Occlusive dressing
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Associazione Infermieristica per lo studio delle Lesioni CutaneeUniversity, hospital or other
- Collaborators
- Artsana S.p.a.
- Study start
- Apr 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 9 Apr 2012 (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 cut injuries and abrasions with particular regard to: Wound healing (complete reepithelialization) and 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 Pressure Sore Status Tool(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 and polyurethane film |
| Traditional Dressing | Active comparator | Device: Gauze and Patch |
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 an injury cut or abrasion (even if sutured)covered by a dressing of 10x8 cm (80 cm2)
- Injury treated with conventional dressings type gauze and patch
- 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
- Subjected systemic corticosteroid therapy / radiotherapy / immunosuppressive therapy
- 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
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 |
| Gauze and PatchTraditional Dressing | Device | Traditional Dressing |
Primary outcome
Wound healing
Time frame: 1 month
Patient's pain
Time frame: 1 month
2 secondary outcomes
Clinical evaluation of the lesion scores for each visit
Time frame: 1 month
The presence / absence of infection for each visit
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Tommaso Bianchi study director
Associazione Infermieristica per lo studio delle Lesioni Cutanee
1 site 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 Gauze and Patch in people with Wounds and Injuries and Abrasion, run by Associazione Infermieristica per lo studio delle Lesioni Cutanee at 1 site 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: finished, 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 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound healing (time frame: 1 month). The study lists 2 primary outcomes in all. 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.