InflammationPhase 3NCT01214811
Open Multi-centre Investigation to Evaluate Signs and Symptoms of Local Inflammation/Infection on Chronic Ulcers and Partial Thickness Burns When Using Mepilex Border Ag as an Anti-microbial Wound Dressing
A Phase 3 study testing Mepilex Border Ag in people with Inflammation and Burns, run by Molnlycke Health Care AB at 3 sites in United States.
Trial summary
The purpose of this study is to evaluate the change in signs of inflammation/local infection when Mepilex Border Ag is used in normal clinical practice when used on chronic ulcers (venous leg, diabetic foot and pressure ulcers) and partial thickness burns in need* of topical antimicrobial treatment according to the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammation, Burns, Ulcers
- What is being tested?
- Mepilex Border Ag
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2010to Dec 2011
- Phase
- Phase 3
- 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
- Subject with a chronic ulcer (venous leg, diabetic foot and pressure ulcers) or a partial thickness burn where an antimicrobial action is indicated* as judged by the investigator
- Male or female, 18 years and above, both in- and out-patients
- Signed Informed Consent Form
Who cannot join
- Wound size equal to or above 9.5x15cm for the wound/burn to be included in the investigation
- Subject not expected to follow the investigation procedures
- TBSA > 10% (partial thickness burns only)
- HbA1C value > 7.2. (To be measured if BMI > 30)
- Pregnant and breastfeeding women
- Pressure ulcers deeper than stage 3
Show all 12Show fewer
- Deep pressure ulcers in need of a filler
- Subjects with known sensitivity to silver or any other dressing materials
- Subjects receiving radiation treatment or examinations e.g. X-ray, ultrasound, diathermy or Magnetic Resonance Imaging
- Subjects using oxidising agents such as hypochlorite solutions or hydrogen peroxide
- 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
3 sites in 1 country.
United States3 sites
Burn treatment center
Iowa City, Iowa, 52242
Institute for advanced wound care
Momtgomery, Alabama, 36111
Center for Curative & Palliative Care, Calvary Hospital
The Bronx, New York, 10461
About this study
The purpose of this study is to evaluate the change in signs of inflammation/local infection when Mepilex Border Ag is used in normal clinical practice when used on chronic ulcers (venous leg, diabetic foot and pressure ulcers) and partial thickness burns in need* of topical antimicrobial treatment according to the physician.
Read the detailed description
The investigation is designed as an open, non-controlled, post-marketing clinical follow-up. Subjects with chronic ulcers or partial thickness burns (including donor sites) at 2 sites will be included. Each subject with a chronic ulcer will be seen once a week for a maximum of 4 weeks or until desired treatment effect is obtained, whichever occurs earlier. Each subject with a partial thickness burn/donor site will be followed once a week for a maximum of 3 weeks or until desired treatment effect is obtained, whichever occurs earlier. All dressing changes will be done according to clinical routine practices and will follow IFU (instruction for use)
- Conditions
- Inflammation, Burns, Ulcers
- Being tested
- Mepilex Border Ag
- Keywords
- The change in signs of inflammation/local infection, To evaluate the comfort, conformability,, Pain during wear
- Medical subject headings
- Inflammation, Burns, Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mepilex Border AgDevice
Mepilex Border Ag may be left in place for up to seven days, depending on the condition.
| Study group | Role | What they receive |
|---|---|---|
| Mepilex Border Ag | Other | Non comparative study with one active arm - Mepilex Border Ag Receives: Device: Mepilex Border Ag |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Are at Baseline
Measured: Baseline
Wound Area at Visit 2
At each visit the wound length and width is measured and calculated in cm2.
Measured: After one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2010 (estimated)
- Study startSep 2010
- Primary completionSep 2011
- Study completionDec 2011
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 InflammationStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Molnlycke Health Care AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Barbara Latenser, MD, Principal investigator, UI burn Treatment Center,200 Hawkings Dr 8JCP Iowa City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01214811
- Sponsor's protocol ID
- MxB Ag 01
- Status last verified
- Dec 2011
- First submitted
- 4 Oct 2010
- Last updated
- 8 Mar 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Multi-centre Investigation to Evaluate Signs and Symptoms of Local Inflammation/Infection on Chronic Ulcers and Partial Thickness Burns When Using Mepilex Border Ag as an Anti-microbial Wound Dressing
- ClinicalTrials.gov ID
- NCT01214811
- Acronym / sponsor ID
- MxB Ag 01
- Conditions
- Inflammation, Burns, Ulcers
- Keywords
- The change in signs of inflammation/local infection, To evaluate the comfort, conformability,, Pain during wear
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Molnlycke Health Care ABIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 5 Oct 2010 (estimated)
- Results
- Posted 26 Feb 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the change in signs of inflammation/local infection when Mepilex Border Ag is used in normal clinical practice when used on chronic ulcers (venous leg, diabetic foot and pressure ulcers) and partial thickness burns in need* of topical antimicrobial treatment according to the physician.
Detailed description
The investigation is designed as an open, non-controlled, post-marketing clinical follow-up. Subjects with chronic ulcers or partial thickness burns (including donor sites) at 2 sites will be included. Each subject with a chronic ulcer will be seen once a week for a maximum of 4 weeks or until desired treatment effect is obtained, whichever occurs earlier. Each subject with a partial thickness burn/donor site will be followed once a week for a maximum of 3 weeks or until desired treatment effect is obtained, whichever occurs earlier. All dressing changes will be done according to clinical routine practices and will follow IFU (instruction for use)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mepilex Border Ag | Other | Device: Mepilex Border AgNon comparative study with one active arm - Mepilex Border Ag |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject with a chronic ulcer (venous leg, diabetic foot and pressure ulcers) or a partial thickness burn where an antimicrobial action is indicated* as judged by the investigator
- Male or female, 18 years and above, both in- and out-patients
- Signed Informed Consent Form
Key exclusion criteria (12 listed)
- Wound size equal to or above 9.5x15cm for the wound/burn to be included in the investigation
- Subject not expected to follow the investigation procedures
- TBSA > 10% (partial thickness burns only)
- HbA1C value > 7.2. (To be measured if BMI > 30)
- Pregnant and breastfeeding women
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 |
|---|---|---|
| Mepilex Border AgMepilex Border Ag may be left in place for up to seven days, depending on the condition. | Device | Mepilex Border Ag |
Primary outcome
Wound Are at Baseline
Time frame: Baseline
Wound Area at Visit 2
Time frame: After one week
At each visit the wound length and width is measured and calculated in cm2.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2013.
- 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.
Barbara Latenser, MD principal investigator
UI burn Treatment Center,200 Hawkings Dr 8JCP Iowa City
3 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 Mepilex Border Ag in people with Inflammation and Burns, run by Molnlycke Health Care AB at 3 sites in United States.
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 12 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 8 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Yes. Results are posted in the registry (first posted 26 Feb 2013). 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?
Wound Are at Baseline (time frame: Baseline). 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 8 Mar 2013.