BurnsNCT01636362
A Clinical Investigation to Evaluate Efficacy of Mepitel Ag in Partial Thickness Second Degree Burns
A study testing Mepitel Ag in people with Burns and Wound Healing, run by Molnlycke Health Care AB at 6 sites in United States.
Trial summary
Approximately 55-65 subjects from 3-6 sites suffering from a burn injury covering 1-25% Total Body Surface Area (TBSA) will be evaluated providing they fulfill all inclusion and none of the exclusion criteria and have given a signed and dated informed consent. Study site will be from 1-15%. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Burns, Wound Healing
- What is being tested?
- Mepitel Ag
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 6 sitesUnited States
- Study dates
- Aug 2012to Aug 2013
- 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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subject with a partial-thickness (superficial, deep or mixed) second degree burn from 1-25% TBSA
- Study site is from 1-15% BSA
- Study site is a single, isolated burn area
- From 2 years and above
- Thermal burn injury
- Signed Informed Consent/Assent Form
- Subjects who are younger than the legal consenting age must in addition to their own Assent form have a signature from a legally authorized representative.
Who cannot join
- Completely non-exuding or dry wound bed at study site
- Full thickness >5%
- Burn greater than 24 hrs old
- Burns to face or neck
- Suspicion of infection of study burn
- Use of chemical/enzymatic and biological debridement within 7 days of investigation start
Show all 15Show fewer
- Chronic steroid use, hx of skin malignancy or chronic papulosquamous disease (e.g. eczema, Pemphigus) and hx of Steven Johnson or TENS disease
- Subject with lung injury or subject being on a ventilator
- Subject with dermatologic skin disorders or necrotizing processes
- Subject with insulin dependent diabetes mellitus
- Electrical, chemical etiology
- Diagnosed underlying disease(s) (e.g. HIV/AIDS, cancer and severe anaemia), judged by the investigator to be a potential interference in the treatment
- Non-compliant subject
- Subject previously included in this investigation
- Subject included in other ongoing clinical investigation at present or during the past 30 days.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Wishard
Indianapolis, Indiana, 46202
Paul Silverstein, MD
Oklahoma City, Oklahoma, 73116
Orlando Regional Medical Center
Orlando, Florida, 32806
S:t Christopher's Hospital for Children
Philadelphia, Pennsylvania, 19134
Arizona Burn Center
Phoenix, Arizona, 85008
Harborview Medical Center
Seattle, Washington, 98104
About this study
Official title: An Open, Non Controlled, Multi-centre, Clinical Investigation to Evaluate Efficacy in Partial Thickness (Superficial, Deep and Mixed) Second Degree Burns When Using a Soft Silicone, Silver Containing, Wound Contact Layer, Mepitel Ag.
Approximately 55-65 subjects from 3-6 sites suffering from a burn injury covering 1-25% Total Body Surface Area (TBSA) will be evaluated providing they fulfill all inclusion and none of the exclusion criteria and have given a signed and dated informed consent. Study site will be from 1-15%. Each subject will be followed once a week for a maximum of 3 weeks or until the burn is healed if that occurs earlier. All dressing changes will be performed at the clinic and gauze rolls will be used as secondary dressing. All dressing changes will be registered in a dressing log. All subjects will be consecutively allocated to a subject code.
Read the detailed description
see Brief summary
- Conditions
- Burns, Wound Healing
- Being tested
- Mepitel Ag
- Keywords
- Partial-thickness second degree burns, Mepitel Ag, Silver dressing
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mepitel AgDevice
Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues.
| Study group | Role | What they receive |
|---|---|---|
| Mepitel Ag | Experimental | Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues. Receives: Device: Mepitel Ag |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Healed at Day 14.
> = 95 % epitheliazation
Measured: Healing will be assessed after 14 days.
Proportion of Subjects Healed at Day 21.
The proportion of subjects healed will be assessed at day 14. Wounds not healed at day 14 will be assessed again at day 21.
Measured: Healing will be assessed after 21 days.
Secondary outcomes (1)
Percent of Study Burn Healed.
Percent of study burn healed measured by PictZar photo analysis of tissue types.
Measured: At day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2012 (estimated)
- Study startAug 2012
- Primary completionAug 2013
- Study completionAug 2013
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
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Molnlycke Health Care AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Silverstein, MD, Principal investigator, INTEGRIS Baptist Medical Center, Inc. Paul Silverstein Burn Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01636362
- Sponsor's protocol ID
- MpT Ag 01
- Status last verified
- Dec 2013
- First submitted
- 26 Jun 2012
- Last updated
- 7 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Non Controlled, Multi-centre, Clinical Investigation to Evaluate Efficacy in Partial Thickness (Superficial, Deep and Mixed) Second Degree Burns When Using a Soft Silicone, Silver Containing, Wound Contact Layer, Mepitel Ag.
- ClinicalTrials.gov ID
- NCT01636362
- Acronym / sponsor ID
- MpT Ag 01
- Conditions
- Burns, Wound Healing
- Keywords
- Partial-thickness second degree burns, Mepitel Ag, Silver dressing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Molnlycke Health Care ABIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 10 Jul 2012 (estimated)
- Results
- Posted 5 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Approximately 55-65 subjects from 3-6 sites suffering from a burn injury covering 1-25% Total Body Surface Area (TBSA) will be evaluated providing they fulfill all inclusion and none of the exclusion criteria and have given a signed and dated informed consent. Study site will be from 1-15%. Each subject will be followed once a week for a maximum of 3 weeks or until the burn is healed if that occurs earlier. All dressing changes will be performed at the clinic and gauze rolls will be used as secondary dressing. All dressing changes will be registered in a dressing log. All subjects will be consecutively allocated to a subject code.
Detailed description
see Brief summary
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mepitel Ag | Experimental | Device: Mepitel AgMepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Subject with a partial-thickness (superficial, deep or mixed) second degree burn from 1-25% TBSA
- Study site is from 1-15% BSA
- Study site is a single, isolated burn area
- From 2 years and above
- Thermal burn injury
Key exclusion criteria (15 listed)
- Completely non-exuding or dry wound bed at study site
- Full thickness >5%
- Burn greater than 24 hrs old
- Burns to face or neck
- Suspicion of infection of study burn
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 AgMepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues. | Device | Mepitel Ag |
Primary outcome
Number of Subjects Healed at Day 14.
Time frame: Healing will be assessed after 14 days.
> = 95 % epitheliazation
Proportion of Subjects Healed at Day 21.
Time frame: Healing will be assessed after 21 days.
The proportion of subjects healed will be assessed at day 14. Wounds not healed at day 14 will be assessed again at day 21.
1 secondary outcome
Percent of Study Burn Healed.
Time frame: At day 21
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2014.
- 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.
Paul Silverstein, MD principal investigator
INTEGRIS Baptist Medical Center, Inc. Paul Silverstein Burn Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mepitel Ag in people with Burns and Wound Healing, run by Molnlycke Health Care AB at 6 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 7 inclusion and 15 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 7 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Sep 2014). 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 Subjects Healed at Day 14. (time frame: Healing will be assessed after 14 days.). 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 7 Oct 2014.