Burn InjuryMpTAg03NCT02210208
A Soft Silicone Wound Contact Layer Containing Silver in the Treatment of Skin Grafts in Surgical Burn Patients.
A study testing Mepitel® Ag and Mepilex® Transfer Ag in people with Burn Injury and Skin Graft, run by Molnlycke Health Care AB at 4 sites in United States.
Trial summary
Part A The primary objective of Part A will be to verify performance and safety of Mepitel® Ag, a meshed, non- adherent soft silicone wound contact layer containing silver in the treatment of skin grafts in surgical burn patients. Read more about this study
- Who is it for?
- Ages 18 months to 65 years
- Conditions the study is for
- Burn Injury, Skin Graft
- What is being tested?
- Mepitel® Ag and Mepilex® Transfer Ag
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 4 sitesUnited States
- Study dates
- Sep 2014to 15 Jun 2016
- 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 months to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects with burn injury resulting in up to 30% TBSA
- Full thickness area of burn should not be more than 20%
- Area in need of skin grafting can be 1-15% TBSA
- Study site area must have healthy, intact peri-wound skin surrounding it to allow for adequate overlap of study product
- Thermal injuries only
- Subjects age 18 months to < 65 years.
Show all 9Show fewer
- Signed informed consent
- 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.
- -There must be healthy, intact peri-wound skin surrounding the planned donor site to allow for adequate overlap of study product (5 cm)
Who cannot join
- Greater than 30% TBSA
- Full thickness areas greater than 20% TBSA
- Full thickness area to be grafted less than 1%
- Presence of respiratory involvement
- Subjects on mechanical ventilation
- Subjects with infected burn wounds
Show all 16Show fewer
- Subjects with organ failure
- Diagnosed underlying disease(s) (e.g. HIV/AIDS, cancer and severe aeaemia) judged by the investigator to be a potential interference in the treatment
- Subjects treated with systemic glucocorticosteroids, except patients taking occasional doses or doses less than 10mg prednisolone/day or equivalent
- Known allergy/hypersensitivity to any of the components of the investigation products.
- Subjects with physical and/or mental conditions that are not expected to comply with the investigation, including patients totally confined to bed
- Participation in other clinical investigation(s) within 1 month prior to start of the investigation
- Previous randomized to this investigation
- Part B
- Investigator do not agree to treat the donor site with Mepilex Transfer Ag
- The subject do not agree to participate in the donor site part
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Long Island Plastic Surgical Group
New York, New York, 11530
The University of South Florida Board of Trustees
Orlando, Florida, 32886-4687
St. Chrisopher's Hospital for Children
Philadelphia, Pennsylvania, 19134
The Arizona Burn Center
Phoenix, Arizona, 85008
About this study
Official title: An Open, Non-controlled, Multi-centre, Clinical Investigation to Verify Performance and Safety of a Soft Silicone Wound Contact Layer Containing Silver in the Treatment of Skin Grafts in Surgical Burn Patients and the Usefulness of a Marketed Donor Site Dressing.
Part A The primary objective of Part A will be to verify performance and safety of Mepitel® Ag, a meshed, non- adherent soft silicone wound contact layer containing silver in the treatment of skin grafts in surgical burn patients.
Part B The primary objective of Part B will be to examine the usefulness of Mepilex® Transfer Ag as an adequate option for donor site healing.
Read the detailed description
This post market clinical follow-up investigation is designed as an open, non-controlled, multi- centre, clinical investigation.
A total of approximately 25 subjects from among 4-6 clinical investigative sites will be evaluated providing they fulfill all the inclusion criteria and none of the exclusion criteria. A signed and dated informed consent/assent will be obtained for all subjects.
Subjects to be included will present with a thermal burn injury that will require skin grafting and result in a donor site. Overall percent Total Body Surface Area (%TBSA) burned will not exceed 30%.
The subjects will be consecutively allocated to a subject code providing they fulfill all inclusion criteria and none of the exclusion criteria and have signed a written consent.
The subjects were participating in the study for 14 days postop.
- Conditions
- Burn Injury, Skin Graft
- Being tested
- Mepitel® Ag, Mepilex® Transfer Ag
- 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
A soft silicone wound contact layer that allows exudates to pass vertically into a secondary absorbent dressing. The product provides fixation and protection of the tissues and has antimicrobial properties.
This silicone net dressing will be used to prevent lifting and adherence of skin grafts to the dressings, as well as to prevent pain, and promote healing.
Mepilex® Transfer AgDevice
Mepilex® Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties.
Mepilex® Transfer Ag consists of a Safetac® adhesive layer and compressed polyurethane foam containing silver sulphate and activated carbon. Safetac® is a unique adhesive technology that minimizes pain to patients and trauma to wounds and the surrounding skin. It minimizes risk for maceration by sealing the wound margins; ensuring exudate does not spread to the surrounding skin.
| Study group | Role | What they receive |
|---|---|---|
| Mepitel® Ag | Experimental | A dressing device used for surgical burn wounds with skin graft. Receives: Device: Mepitel® Ag |
| Mepilex® Transfer Ag | Experimental | Donor site dressing device in the very same patient. Receives: Device: Mepilex® Transfer Ag |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: Number of Participants With Healing
Part A: Adequate take of skin graft (defined as at least 95% adherent and healed as assessed by clinical investigator).
Measured: 14 days
Part B
Part B: The healing percentage of donor sites (defined as greater than 95% epithelialization, verified by quantitative photographic analysis).
Measured: 14 days with 2 visits
Secondary outcomes (2)
Part A Secondary Outcome.
Satisfactory fixation of the product over the skin graft was assessed by a series of questions regarding the product assessment of product in place at each visit.
Ability to pass exudate to the secondary dressing was demonstrated by a series of questions regarding the exudate at each visit as well as the adherence of the dressing at removal which would show the ability of the dressing to pass the exudate to the secondary dressing rather than creating eschar between the wound and the dressing.
Measured: 14 days with 2 visits
Part B Secondary Outcome.
Ability of Mepilex® Transfer Ag to adhere to donor site without slippage.
Measured: 14 days with 2 visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionJun 2016
- Study completion15 Jun 2016
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 Burn InjuryStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two Parts (part A and B) with one dressing device for the skin graft placed on a surgical burn wound and another dressing device placed on the donor site.
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Molnlycke Health Care AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Glat, Professor, Principal investigator, Drexel University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02210208
- Sponsor's protocol ID
- MpTAg03
- Acronym
- MpTAg03
- Status last verified
- Dec 2017
- First submitted
- 5 Aug 2014
- Last updated
- 10 Jan 2018
- 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 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Non-controlled, Multi-centre, Clinical Investigation to Verify Performance and Safety of a Soft Silicone Wound Contact Layer Containing Silver in the Treatment of Skin Grafts in Surgical Burn Patients and the Usefulness of a Marketed Donor Site Dressing.
- ClinicalTrials.gov ID
- NCT02210208
- Acronym / sponsor ID
- MpTAg03 / MpTAg03
- Conditions
- Burn Injury, Skin Graft
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Molnlycke Health Care ABIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- 15 Jun 2016 (actual)
- First posted
- 6 Aug 2014 (estimated)
- Results
- Posted 2 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Part A The primary objective of Part A will be to verify performance and safety of Mepitel® Ag, a meshed, non- adherent soft silicone wound contact layer containing silver in the treatment of skin grafts in surgical burn patients.
Part B The primary objective of Part B will be to examine the usefulness of Mepilex® Transfer Ag as an adequate option for donor site healing.
Detailed description
This post market clinical follow-up investigation is designed as an open, non-controlled, multi- centre, clinical investigation.
A total of approximately 25 subjects from among 4-6 clinical investigative sites will be evaluated providing they fulfill all the inclusion criteria and none of the exclusion criteria. A signed and dated informed consent/assent will be obtained for all subjects.
Subjects to be included will present with a thermal burn injury that will require skin grafting and result in a donor site. Overall percent Total Body Surface Area (%TBSA) burned will not exceed 30%.
The subjects will be consecutively allocated to a subject code providing they fulfill all inclusion criteria and none of the exclusion criteria and have signed a written consent.
The subjects were participating in the study for 14 days postop.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two Parts (part A and B) with one dressing device for the skin graft placed on a surgical burn wound and another dressing device placed on the donor site.
| Arm | Type | Receives |
|---|---|---|
| Mepitel® Ag | Experimental | Device: Mepitel® AgA dressing device used for surgical burn wounds with skin graft. |
| Mepilex® Transfer Ag | Experimental | Device: Mepilex® Transfer AgDonor site dressing device in the very same patient. |
Who may qualify
- Ages
- 18 months to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects with burn injury resulting in up to 30% TBSA
- Full thickness area of burn should not be more than 20%
- Area in need of skin grafting can be 1-15% TBSA
- Study site area must have healthy, intact peri-wound skin surrounding it to allow for adequate overlap of study product
- Thermal injuries only
Key exclusion criteria (16 listed)
- Greater than 30% TBSA
- Full thickness areas greater than 20% TBSA
- Full thickness area to be grafted less than 1%
- Presence of respiratory involvement
- Subjects on mechanical ventilation
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® AgA soft silicone wound contact layer that allows exudates to pass vertically into a secondary absorbent dressing. The product provides fixation and protection of the tissues and has antimicrobial properties. This silicone net dressing will be used to prevent lifting and adherence of skin grafts to the dressings, as well as to prevent pain, and promote healing. | Device | Mepitel® Ag |
| Mepilex® Transfer AgMepilex® Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties. Mepilex® Transfer Ag consists of a Safetac® adhesive layer and compressed polyurethane foam containing silver sulphate and activated carbon. Safetac® is a unique adhesive technology that minimizes pain to patients and trauma to wounds and the surrounding skin. It minimizes risk for maceration by sealing the wound margins; ensuring exudate does not spread to the surrounding skin. | Device | Mepilex® Transfer Ag |
Primary outcome
Part A: Number of Participants With Healing
Time frame: 14 days
Part A: Adequate take of skin graft (defined as at least 95% adherent and healed as assessed by clinical investigator).
Part B
Time frame: 14 days with 2 visits
Part B: The healing percentage of donor sites (defined as greater than 95% epithelialization, verified by quantitative photographic analysis).
2 secondary outcomes
Part A Secondary Outcome.
Time frame: 14 days with 2 visits
Part B Secondary Outcome.
Time frame: 14 days with 2 visits
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Burn Injury
Not yet recruiting
Effect of Short-Video Distraction During Burn Dressing on Anxiety, Pain, and Fear in Children
Burn Injury, Procedural Anxiety
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Peer Bullying Intervention, Vodcast
Recruiting
Hand Function Outcome After the Application of Transfer Energy Capacitive and Resistive on Post-burn Patients Presented With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS) Post-burn
RecruitingPhase 2
Dupixent in Adults With Refractory Post-Burn Pruritus in an Ambulatory Clinic
Pruritis
Recruiting
Efferon LPS Hemoadsorption in in Patients With Thermal Burns
Burns
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 Glat, Professor principal investigator
Drexel University College of Medicine
4 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 and Mepilex® Transfer Ag in people with Burn Injury and Skin Graft, run by Molnlycke Health Care AB at 4 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 9 inclusion and 16 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 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 2 Aug 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?
Part A: Number of Participants With Healing (time frame: 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 10 Jan 2018.