BurnsNCT01418482
Evaluation of Antimicrobial Soft Silicone, Silver Containing, Foam Dressing, Mepilex Border Ag, in Second Degree Burns
A study testing Mepilex Border Ag in people with Burns, run by Molnlycke Health Care AB at 2 sites in Sweden.
Trial summary
The investigation is designed as an open, non-controlled, post-marketing investigation. Subjects with at least one second degree burn less than 9.5x15 cm in size at 1-3 sites will be included. The subject is allowed to have more than one burn on the body but only one should be included in the investigation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burns
- 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
- 15 participants
- Where
- 2 sitesSweden
- Study dates
- Jan 2011to Jul 2011
- 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
- Subject with a small partial thickness burn (< 9.5x15 cm) where an antimicrobial action is indicated as judged by the investigator*
- Male or female, 18 years and above, both in- and out-patient subjects
- Signed Informed Consent Form
Who cannot join
- Wound size equal to or above 9.5x15cm for the selected burn for the investigation
- Pregnant and/or breastfeeding women
- Subject not expected to follow the investigation procedures or applicable for investigation according to the judgment of the investigator
- Subjects with known sensitivity to silver or any other contents of the dressing
- 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
2 sites in 1 country.
About this study
Official title: An Open Non-controlled Post-marketing Investigation Evaluating the Experience of Using a Self- Adherent Antimicrobial Soft Silicone, Silver Containing, Foam Dressing, Mepilex Border Ag, in Second Degree Burns
The investigation is designed as an open, non-controlled, post-marketing investigation. Subjects with at least one second degree burn less than 9.5x15 cm in size at 1-3 sites will be included. The subject is allowed to have more than one burn on the body but only one should be included in the investigation. Each subject will be followed/assessed according to normal hospital routine 1-3 times per week for a maximum of 3 weeks or until desired treatment effect is obtained if that occurs earlier. All dressing changes will be done according to clinical routine and will follow the IFU (instruction for use). All dressing changes will be registered in a dressing log. Additional compression bandaging, gauze wrap, or such are allowed and should be reported as well
Read the detailed description
At baseline, subject characteristics will be registered together with subject status of health and status of the burn, and current treatment of the burn.
At each visit the following variables will be collected where applicable:
- Investigator's/Nurse evaluation of
- Overall experience of the dressing
- Ability of dressing to stay in place (not at baseline)
- Conformability of the dressing
- Handling at application
- Ease of removal of the dressing (not at baseline)
- Subject evaluation of
- Overall experience of the dressing
- Comfort of the dressing
- Conformability of the dressing
- Pain before, during and after removal of dressing according to VAS
- Status of skin
- Burn status: width x length, exudate details and signs of inflammation/infection
In addition the following variables should be evaluated at each visit:
- Concomitant medication/treatment
- Adverse Event/Adverse Device Effect (AE/ADE)
- Serious Adverse Event/Serious Adverse Device Effect (sAE/sADE)
Photos will be taken before Mepilex Border Ag is removed, after removal, before cleansing, and after cleansing. All photos must include a sticker marker with subject code, visit number and date, and an indication of whether pre-/post removal, pre-/post cleansing. The stick marker also contains a ruler. Detailed instructions on how to take the photos is given in Appendix 14.2
At each visit the subject will give the assessment concerning the comfort and stay-on-ability of the dressing. The investigator will also give an assessment at each visit concerning handling, conformability and ability of dressing to stay in place.
- Conditions
- Burns
- Being tested
- Mepilex Border Ag
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mepilex Border AgDevice
a silver dressing
| Study group | Role | What they receive |
|---|---|---|
| Mepilex Border Ag | Experimental | Mepilex Border Ag, a silver dressing will be used Receives: Device: Mepilex Border Ag |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the Experience of Using Mepilex Border Ag ( a Silver Dressing) in Normal Clinical Practice
burns healed
Measured: 3 weeks
Secondary outcomes (2)
Evaluate the Comfort
Comfort level and overall experience were each assessed using a scale that ranged from very poor to very good.
Measured: 3 weeks
Pain
To evaluate pain during dressing removal at visit 4,(after one week) with John Hopkins pain scale. Measured 0=no pain, 100= worst pain, scale from 0-100 mm
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2011 (estimated)
- Study startJan 2011
- Primary completionJul 2011
- Study completionJul 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 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Molnlycke Health Care AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fredrik Huss, MD, Principal investigator, Akademiska Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01418482
- Sponsor's protocol ID
- MxB Ag 02
- Status last verified
- Aug 2011
- First submitted
- 27 Jan 2011
- Last updated
- 5 Jun 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 5 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Non-controlled Post-marketing Investigation Evaluating the Experience of Using a Self- Adherent Antimicrobial Soft Silicone, Silver Containing, Foam Dressing, Mepilex Border Ag, in Second Degree Burns
- ClinicalTrials.gov ID
- NCT01418482
- Acronym / sponsor ID
- MxB Ag 02
- Conditions
- Burns
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Molnlycke Health Care ABIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 17 Aug 2011 (estimated)
- Results
- Posted 3 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigation is designed as an open, non-controlled, post-marketing investigation. Subjects with at least one second degree burn less than 9.5x15 cm in size at 1-3 sites will be included. The subject is allowed to have more than one burn on the body but only one should be included in the investigation. Each subject will be followed/assessed according to normal hospital routine 1-3 times per week for a maximum of 3 weeks or until desired treatment effect is obtained if that occurs earlier. All dressing changes will be done according to clinical routine and will follow the IFU (instruction for use). All dressing changes will be registered in a dressing log. Additional compression bandaging, gauze wrap, or such are allowed and should be reported as well
Detailed description
At baseline, subject characteristics will be registered together with subject status of health and status of the burn, and current treatment of the burn.
At each visit the following variables will be collected where applicable:
- Investigator's/Nurse evaluation of
- Overall experience of the dressing
- Ability of dressing to stay in place (not at baseline)
- Conformability of the dressing
- Handling at application
- Ease of removal of the dressing (not at baseline)
- Subject evaluation of
- Overall experience of the dressing
- Comfort of the dressing
- Conformability of the dressing
- Pain before, during and after removal of dressing according to VAS
- Status of skin
- Burn status: width x length, exudate details and signs of inflammation/infection
In addition the following variables should be evaluated at each visit:
- Concomitant medication/treatment
- Adverse Event/Adverse Device Effect (AE/ADE)
- Serious Adverse Event/Serious Adverse Device Effect (sAE/sADE)
Photos will be taken before Mepilex Border Ag is removed, after removal, before cleansing, and after cleansing. All photos must include a sticker marker with subject code, visit number and date, and an indication of whether pre-/post removal, pre-/post cleansing. The stick marker also contains a ruler. Detailed instructions on how to take the photos is given in Appendix 14.2
At each visit the subject will give the assessment concerning the comfort and stay-on-ability of the dressing. The investigator will also give an assessment at each visit concerning handling, conformability and ability of dressing to stay in place.
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 | Experimental | Device: Mepilex Border AgMepilex Border Ag, a silver dressing will be used |
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 small partial thickness burn (< 9.5x15 cm) where an antimicrobial action is indicated as judged by the investigator*
- Male or female, 18 years and above, both in- and out-patient subjects
- Signed Informed Consent Form
Key exclusion criteria (6 listed)
- Wound size equal to or above 9.5x15cm for the selected burn for the investigation
- Pregnant and/or breastfeeding women
- Subject not expected to follow the investigation procedures or applicable for investigation according to the judgment of the investigator
- Subjects with known sensitivity to silver or any other contents of the dressing
- Subjects previously included in this 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 |
|---|---|---|
| Mepilex Border Aga silver dressing | Device | Mepilex Border Ag |
Primary outcome
Evaluate the Experience of Using Mepilex Border Ag ( a Silver Dressing) in Normal Clinical Practice
Time frame: 3 weeks
burns healed
2 secondary outcomes
Evaluate the Comfort
Time frame: 3 weeks
Pain
Time frame: 3 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 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.
Fredrik Huss, MD principal investigator
Akademiska Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mepilex Border Ag in people with Burns, run by Molnlycke Health Care AB at 2 sites in Sweden.
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 6 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 5 Jun 2017. 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 Sweden. 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 3 May 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?
Evaluate the Experience of Using Mepilex Border Ag ( a Silver Dressing) in Normal Clinical Practice (time frame: 3 weeks). 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 5 Jun 2017.