PainOnlyNCT02237118
Prospective, Randomized, Non-inferiority Investigation to Compare Effects of Mepitel® One and UrgoTul® Dressings in Acute Wound Management (Only)"
A study testing Mepitel One and UrgoTul in people with Pain, run by Molnlycke Health Care AB at 1 site in France.
Trial summary
To compare the effects of pain of the two dressings, Mepitel® One and UrgoTul® in acute wound management. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Mepitel One and UrgoTul
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Acute wound: traumatic wound (dermabrasion, skin tears, other), benign burn requiring the use of dressings
- Acute wound size between 3 cm² and 240 cm2 (wound could be covered by 2 investigational products maximum)
- Wound whose duration is ≤ 3 days
- Both gender with an age ≥ 18 years
- Subject able to understand and voluntarily sign the informed consent
- Subject able to follow the protocol
- Subject insured to the French social security system
Who cannot join
- Surgical wound
- Infected, moderately to strongly exudative and haemorrhagic wound
- Diagnosed underlying disease (e.g. diabetic neuropathy, stroke, …) which, as judged by the investigator, could interfere with the pain assessment
- Known allergy/hypersensitivity to any of the components of the investigational products
- Participation in other clinical investigation within one month prior to start of investigation
- Pregnant or breast-feeding women
- Person protected by a legal regime (tutorship or guardianship)
Trial locations and contacts
1 site in 1 country.
About this study
To compare the effects of pain of the two dressings, Mepitel® One and UrgoTul® in acute wound management.
- Conditions
- Pain
- Being tested
- Mepitel One, UrgoTul
- Keywords
- Acute, wound, management, measured, Visual analoge scale
- Medical subject headings
- Pain, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mepitel OneDevice
UrgoTulDevice
| Study group | Role | What they receive |
|---|---|---|
| Mepitel One | Active comparator | Pain on dressing removal, by VAS Receives: Device: Mepitel One; Device: UrgoTul |
| UrgoTul | Active comparator | Pain on removal by VAS Receives: Device: Mepitel One; Device: UrgoTul |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Non-Painful Dressing Removal, Measured by Visual Aanalog Scale (VAS)
To compare the effects of pain of the two dressings, Mepitel® One and UrgoTul®, during the first dressing removal. Pain measured by VAS Score ≥ 30 mm on the 100 mm VAS scale are reported.
Measured: 21 days
Secondary outcomes (4)
Complete Healing at Day 21, Will be Measured Using PictZar ( Digital Planimetric System) System.
Complete healing at day 21, will be measured using PictZar system.
Measured: 21 days
Condition of the Wound, Will be Assesst by the Investigator.
wound size estimation, assesstemnt of the wound,
Measured: 21 days
Safety
Adverse Event, Adverse Device Event
Measured: 21 days
Assessment of the Surrounding Skin.
assessment of the surrounding skin.
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionNov 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PainStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Molnlycke Health Care AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anna Solanilla, Dr, Principal investigator, Clinique Mutualiste du Medoc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02237118
- Sponsor's protocol ID
- MPTO 05
- Acronym
- Only
- Status last verified
- Sep 2014
- First submitted
- 5 Sep 2014
- Last updated
- 10 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Non-inferiority Investigation to Compare Effects of Mepitel® One and UrgoTul® Dressings in Acute Wound Management (Only)"
- ClinicalTrials.gov ID
- NCT02237118
- Acronym / sponsor ID
- Only / MPTO 05
- Conditions
- Pain
- Keywords
- Acute, wound, management, measured, Visual analoge scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Molnlycke Health Care ABIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 11 Sep 2014 (estimated)
- Results
- Posted 10 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the effects of pain of the two dressings, Mepitel® One and UrgoTul® in acute wound management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mepitel One | Active comparator | Device: Mepitel One, Device: UrgoTulPain on dressing removal, by VAS |
| UrgoTul | Active comparator | Device: Mepitel One, Device: UrgoTulPain on removal by VAS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Acute wound: traumatic wound (dermabrasion, skin tears, other), benign burn requiring the use of dressings
- Acute wound size between 3 cm² and 240 cm2 (wound could be covered by 2 investigational products maximum)
- Wound whose duration is ≤ 3 days
- Both gender with an age ≥ 18 years
- Subject able to understand and voluntarily sign the informed consent
Key exclusion criteria (7 listed)
- Surgical wound
- Infected, moderately to strongly exudative and haemorrhagic wound
- Diagnosed underlying disease (e.g. diabetic neuropathy, stroke, …) which, as judged by the investigator, could interfere with the pain assessment
- Known allergy/hypersensitivity to any of the components of the investigational products
- Participation in other clinical investigation within one month prior to start of investigation
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 |
|---|---|---|
| Mepitel One | Device | Mepitel One, UrgoTul |
| UrgoTul | Device | Mepitel One, UrgoTul |
Primary outcome
Number of Participants With Non-Painful Dressing Removal, Measured by Visual Aanalog Scale (VAS)
Time frame: 21 days
To compare the effects of pain of the two dressings, Mepitel® One and UrgoTul®, during the first dressing removal. Pain measured by VAS Score ≥ 30 mm on the 100 mm VAS scale are reported.
4 secondary outcomes
Complete Healing at Day 21, Will be Measured Using PictZar ( Digital Planimetric System) System.
Time frame: 21 days
Condition of the Wound, Will be Assesst by the Investigator.
Time frame: 21 days
Safety
Time frame: 21 days
Assessment of the Surrounding Skin.
Time frame: 21 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Anna Solanilla, Dr principal investigator
Clinique Mutualiste du Medoc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mepitel One and UrgoTul in people with Pain, run by Molnlycke Health Care AB at 1 site in France.
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 7 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 10 Apr 2017. 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 France. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Non-Painful Dressing Removal, Measured by Visual Aanalog Scale (VAS) (time frame: 21 days). 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 10 Apr 2017.