Acute WoundsNCT01164982
Investigation Evaluating Handling of Mepitel® One Used in Acute Wounds in Home Care
A study testing Mepitel One in people with Acute Wounds, run by Molnlycke Health Care AB at 1 site in Germany.
Trial summary
The primary objective is to evaluate the handling of Mepitel® One when used in acute wounds in home care. Secondary objective is to evaluate the comfort, conformability, stay-on ability, pain at removal, transparency of dressing and adverse events. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Wounds
- What is being tested?
- Mepitel One
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2010to Nov 2010
- Phase
- Interventional
- 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
- Acute wounds/burns
- Male or female, 18 years and above, both in- and outpatients.
- Signed Informed Consent Form
Who cannot join
- Wound size above 21x24.5 cm
- Subject not expected to follow the investigation procedures
- Subjects previously included in this investigation
- Subjects included in other ongoing clinical investigation at present or during the past 30 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Non-controlled Proof of Concept Investigation Evaluating the Handling of a Soft Silicone Wound Contact Layer, Mepitel® One Used in Acute Wounds in Home Care
The primary objective is to evaluate the handling of Mepitel® One when used in acute wounds in home care.
Secondary objective is to evaluate the comfort, conformability, stay-on ability, pain at removal, transparency of dressing and adverse events.
Read the detailed description
The investigation is designed as an open, non-controlled, proof of concept investigation. Subjects with acute wounds at one centre will be included. Each subject will be followed once a week for 3 weeks or until healing if that occurs earlier. All dressing changes will be done according to clinical routine and registered in a dressing log. Cover dressing will be used when needed according to clinical routine.
A total of 10 subjects will be enrolled provided that they fulfil all the inclusion criteria and none of the exclusion criteria and have signed and dated the written informed consent.
The subjects will be consecutively allocated to a subject code.
At baseline, subject characteristics will be registered together with subject status of health, wound history and wound status, wound characteristics and current treatment of the wound.
The following variables will be measured as follows:
- Conditions
- Acute Wounds
- Being tested
- Mepitel One
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mepitel OneDevice
Each subject will be followed once a week for 3 weeks or until healing if that occurs earlier
What is being measured
The primary outcome is the main question the study is designed to answer.
to evaluate the handling of Mepitel® One when used in acute wounds in home care.
Measured: once a week for 3 weeks or until healing
Secondary outcomes (1)
to evaluate the comfort, conformability, stay-on ability, pain at removal, transparency of dressing and adverse events.
Measured: once a week for 3 weeks or until healing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2010 (estimated)
- Study startMar 2010
- Primary completionAug 2010 (estimated)
- Study completionNov 2010 (estimated)
Why it stopped: No resources available at the clinic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute WoundsStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Molnlycke Health Care AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Hans J Höning, Dr, Principal investigator, Chir-Praxis, Hamburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01164982
- Sponsor's protocol ID
- MPTO 02
- Status last verified
- Dec 2010
- First submitted
- 16 Jul 2010
- Last updated
- 28 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Non-controlled Proof of Concept Investigation Evaluating the Handling of a Soft Silicone Wound Contact Layer, Mepitel® One Used in Acute Wounds in Home Care
- ClinicalTrials.gov ID
- NCT01164982
- Acronym / sponsor ID
- MPTO 02
- Conditions
- Acute Wounds
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No resources available at the clinic
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Molnlycke Health Care ABIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Aug 2010 (estimated)
- Study completion
- Nov 2010 (estimated)
- First posted
- 19 Jul 2010 (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.
The primary objective is to evaluate the handling of Mepitel® One when used in acute wounds in home care.
Secondary objective is to evaluate the comfort, conformability, stay-on ability, pain at removal, transparency of dressing and adverse events.
Detailed description
The investigation is designed as an open, non-controlled, proof of concept investigation. Subjects with acute wounds at one centre will be included. Each subject will be followed once a week for 3 weeks or until healing if that occurs earlier. All dressing changes will be done according to clinical routine and registered in a dressing log. Cover dressing will be used when needed according to clinical routine.
A total of 10 subjects will be enrolled provided that they fulfil all the inclusion criteria and none of the exclusion criteria and have signed and dated the written informed consent.
The subjects will be consecutively allocated to a subject code.
At baseline, subject characteristics will be registered together with subject status of health, wound history and wound status, wound characteristics and current treatment of the wound.
The following variables will be measured as follows:
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Acute wounds/burns
- Male or female, 18 years and above, both in- and outpatients.
- Signed Informed Consent Form
Key exclusion criteria (4 listed)
- Wound size above 21x24.5 cm
- Subject not expected to follow the investigation procedures
- Subjects previously included in this investigation
- Subjects included in other ongoing clinical investigation at present or during the past 30 days
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 OneEach subject will be followed once a week for 3 weeks or until healing if that occurs earlier | Device | – |
Primary outcome
to evaluate the handling of Mepitel® One when used in acute wounds in home care.
Time frame: once a week for 3 weeks or until healing
1 secondary outcome
to evaluate the comfort, conformability, stay-on ability, pain at removal, transparency of dressing and adverse events.
Time frame: once a week for 3 weeks or until healing
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2015.
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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.
Hans J Höning, Dr principal investigator
Chir-Praxis, Hamburg
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 in people with Acute Wounds, run by Molnlycke Health Care AB at 1 site in Germany.
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 3 inclusion and 4 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: withdrawn, as of the sponsor's last update on 28 Apr 2015. 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 Germany. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
to evaluate the handling of Mepitel® One when used in acute wounds in home care. (time frame: once a week for 3 weeks or until healing). 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 28 Apr 2015.