Treatment of Partial Thickness BurnsNCT02765737
Dehydrated Human Amnion Chorion Membrane (dHACM) vs. Control in the Treatment of Partial Thickness Burns.
A study testing Dehydrated Human Amnion/Chorion Membrane and Mepilex Ag in people with Treatment of Partial Thickness Burns, run by MiMedx Group, Inc. at 6 sites in United States.
Trial summary
Multicenter, prospective, randomized, controlled feasibility trial to determine the safety and effectiveness of Dehydrated Human Amnion Chorion Membrane (dHACM) plus Control as compared to Control alone for the treatment of second degree burns (partial thickness burns) as assessed by time to healing and scarring Read more about this study
- Who is it for?
- Ages 12 months to 70 years
- Conditions the study is for
- Treatment of Partial Thickness Burns
- What is being tested?
- Dehydrated Human Amnion/Chorion Membrane and Mepilex Ag
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 6 sitesUnited States
- Study dates
- Apr 2016to Jan 2019
- 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 12 months to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- ll patients enrolled must meet all the following criteria:
- Patient with burn injury that meets all of the following requirements:
- Occurred within the last 48 hours
- Wound is thermal in nature
- Partial-thickness burn (burn extends through the epidermis and may penetrate into the dermis)
- Total body surface area (TBSA) of burn(s) is 2-20% for all subjects
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- Burn area(s) located on smooth, flat surface
- 2 burn areas, each with a minimum size of 16cm2 (burn areas may be two separate burns or within one large burn, see Section 9.4.2)
- Age ≥ 12 months and ≤ 70 years
Who cannot join
- Subjects meeting any of the following criteria will be excluded:
- Burns meeting any of the following criteria:
- Mechanism of injury was electrical, radiation, chemical or frostbite
- Wound is larger than 200 cm2
- Clinically infected burn (as judged by the investigator)
- Previous or planned treatment of the Burn Area(s) with any of the following:
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- Biological Skin Substitutes (including Apligraf®, Dermagraft®, etc.)
- Patient criteria that will make patient ineligible for enrollment:
- Ventilator dependence
- Active malignant disease or patient is less than 1 year disease-free
- Use of immunosuppressive agents, radiation or chemotherapy within the past 30 days
- Auto-immune disorders including Systemic Lupus Erythematosus (SLE), Fibromyalgia, Acquired Immunodeficiency Syndrome (AIDS) or Human Immunodeficiency Virus (HIV)
- Presence of any condition (including current drug or alcohol abuse, medical or psychiatric condition) that is likely to impair understanding of or compliance with the study protocol in the judgment of the Investigator
- Presence of any condition that is likely to compromise healing in the judgment of the Investigator
- Pregnancy at enrollment or within last 6 months, women who are breastfeeding, or women of childbearing potential who are planning to become pregnant during the time of the study OR are unwilling/unable to use acceptable methods of contraception (birth control pills, barriers, or abstinence)
- Patient has been on any investigational drug(s) or therapeutic device(s) in the last 30 days or any previous enrollment in this study
- Allergy or known sensitivity to any of the following:
- Aminoglycosides such as gentamicin sulfate and/or streptomycin sulfate
- Silver
- -
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Bruce Cairns Surgery Burn Center
Chapel Hill, North Carolina, 27514
St Elizabeth Reg Med Center
Lincoln, Nebraska, 68506
Keck School of Medicine
Los Angeles, California, 90032
Drexel University
Philadelphia, Pennsylvania, 19140
Arizona Burn Center
Phoenix, Arizona, 85008
University of San Diego Nedical Center
San Diego, California, 92103
About this study
Multicenter, prospective, randomized, controlled feasibility trial to determine the safety and effectiveness of Dehydrated Human Amnion Chorion Membrane (dHACM) plus Control as compared to Control alone for the treatment of second degree burns (partial thickness burns) as assessed by time to healing and scarring
Read the detailed description
Multicenter, prospective, randomized, controlled feasibility trial to determine the safety and effectiveness of Dehydrated Human Amnion Chorion Membrane (dHACM) plus Control as compared to Control alone for the treatment of second degree burns as assessed by time to healing and scarring
- Conditions
- Treatment of Partial Thickness Burns
- Being tested
- Dehydrated Human Amnion/Chorion Membrane, Mepilex Ag
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dehydrated Human Amnion/Chorion MembraneOther
Also called dHACM
Dehydrated human amnion/chorion membrane (dHACM) product and is regulated as a Human Cells, Tissues and Cellular and Tissue Based Product (HCT/P) under Section 361 of the Public Health Service Act by the Food and Drug Administration (FDA).
Mepilex AgDevice
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Treatment 1 - dHACM plus Control Burn Area A Treatment 2 - Control Burn Area B Receives: Other: Dehydrated Human Amnion/Chorion Membrane; Device: Mepilex Ag |
| Group 2 | Active comparator | Treatment 1 - dHACM plus Control Burn Area B Treatment 2 - Control Burn Area A Receives: Other: Dehydrated Human Amnion/Chorion Membrane; Device: Mepilex Ag |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing Rate
95% epitheliazation as assesses by the investigator
Measured: 3 weeks
Freedom from Scarring
Vancouver Scar Scale: consists of four variables: pliability, vascularity, height (thickness), and pigmentation. Each variable has four to six possible scores. A total score ranges from 0 to 14, whereby a score of 0 reflects normal skin.
Measured: 3 Months
Secondary outcomes (1)
Reduction in pain
Visual Analog Scale or FLACC Behavioral Pain Assessment Scale:VAS-No pain on left of line, worst pain imaginable on the right of line; FLACC- 0-2, (0 being least uncomfortable to 2 which is very uncomfortable)
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 posted9 May 2016 (estimated)
- Study startApr 2016
- Primary completionJan 2019
- Study completionJan 2019
Why it stopped: Slow enrollment, issues with inclusion/exclusion and choice of control
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment of Partial Thickness 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- MiMedx Group, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Mason, MD, Study director, Chief Medical Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02765737
- Sponsor's protocol ID
- EFBUR002
- Status last verified
- Nov 2020
- First submitted
- 5 May 2016
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dehydrated Human Amnion Chorion Membrane (dHACM) vs. Control in the Treatment of Partial Thickness Burns.
- ClinicalTrials.gov ID
- NCT02765737
- Acronym / sponsor ID
- EFBUR002
- Conditions
- Treatment of Partial Thickness Burns
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment, issues with inclusion/exclusion and choice of control
- Enrolment
- 23 participants (actual)
- Lead sponsor
- MiMedx Group, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 9 May 2016 (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.
Multicenter, prospective, randomized, controlled feasibility trial to determine the safety and effectiveness of Dehydrated Human Amnion Chorion Membrane (dHACM) plus Control as compared to Control alone for the treatment of second degree burns (partial thickness burns) as assessed by time to healing and scarring
Detailed description
Multicenter, prospective, randomized, controlled feasibility trial to determine the safety and effectiveness of Dehydrated Human Amnion Chorion Membrane (dHACM) plus Control as compared to Control alone for the treatment of second degree burns as assessed by time to healing and scarring
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Other: Dehydrated Human Amnion/Chorion Membrane, Device: Mepilex AgTreatment 1 - dHACM plus Control Burn Area A Treatment 2 - Control Burn Area B |
| Group 2 | Active comparator | Other: Dehydrated Human Amnion/Chorion Membrane, Device: Mepilex AgTreatment 1 - dHACM plus Control Burn Area B Treatment 2 - Control Burn Area A |
Who may qualify
- Ages
- 12 months to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Patient with burn injury that meets all of the following requirements:
- Age ≥ 12 months and ≤ 70 years
Key exclusion criteria (20 listed)
- Burns meeting any of the following criteria:
- Patient criteria that will make patient ineligible for enrollment:
- Allergy or known sensitivity to any of the following:
- -
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 |
|---|---|---|
| Dehydrated Human Amnion/Chorion MembraneAlso: dHACMDehydrated human amnion/chorion membrane (dHACM) product and is regulated as a Human Cells, Tissues and Cellular and Tissue Based Product (HCT/P) under Section 361 of the Public Health Service Act by the Food and Drug Administration (FDA). | Other | Group 1, Group 2 |
| Mepilex Ag | Device | Group 1, Group 2 |
Primary outcome
Healing Rate
Time frame: 3 weeks
95% epitheliazation as assesses by the investigator
Freedom from Scarring
Time frame: 3 Months
Vancouver Scar Scale: consists of four variables: pliability, vascularity, height (thickness), and pigmentation. Each variable has four to six possible scores. A total score ranges from 0 to 14, whereby a score of 0 reflects normal skin.
1 secondary outcome
Reduction in pain
Time frame: 3 weeks
Results and safety
The study was stopped early (reason given: Slow enrollment, issues with inclusion/exclusion and choice of control). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Individual participant dataSharing planned: No
Related trials for Treatment of Partial Thickness Burns
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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.
David Mason, MD study director
Chief Medical Officer
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dehydrated Human Amnion/Chorion Membrane and Mepilex Ag in people with Treatment of Partial Thickness Burns, run by MiMedx Group, Inc. 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 9 inclusion and 20 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: stopped early, as of the sponsor's last update on 17 May 2022. 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?
The study was stopped early (reason given: Slow enrollment, issues with inclusion/exclusion and choice of control). Results are not available in the source record.
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?
Healing Rate (time frame: 3 weeks). 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 17 May 2022.