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Dehydrated Human Amnion Chorion Membrane (dHACM) vs. Control in the Treatment of Partial Thickness Burns.

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ClinicalTrials.gov Identifier: NCT02765737
Recruitment Status : Recruiting
First Posted : May 9, 2016
Last Update Posted : August 24, 2018
Sponsor:
Information provided by (Responsible Party):
MiMedx Group, Inc.

May 5, 2016
May 9, 2016
August 24, 2018
April 2016
December 2018   (Final data collection date for primary outcome measure)
  • Healing Rate [ Time Frame: 3 weeks ]
  • Freedom from Scarring [ Time Frame: 3 Months ]
  • Healing Rate [ Time Frame: 3 weeks ]
    The primary healing endpoint of this study is the time to complete healing, defined as complete epithelialization, as assessed at 3 weeks.
  • Freedom from Scarring [ Time Frame: 3 Months ]
    The primary scarring endpoint of this study is the degree of scarring as assessed by the Vancouver Scar Scale at 1 year.
Complete list of historical versions of study NCT02765737 on ClinicalTrials.gov Archive Site
Reduction in pain [ Time Frame: 3 weeks ]
Reduction in pain [ Time Frame: 3 weeks ]
To compare patient reported perception of pain for EpiFix® and Control based on the Visual Analog Scale (VAS) (subjects ≥ age 13) or Wong-Baker FACES® Pain Rating Scale or FLACC Behavioral Pain Assessment Scale for children < 13
Not Provided
Not Provided
 
Dehydrated Human Amnion Chorion Membrane (dHACM) vs. Control in the Treatment of Partial Thickness Burns.
Dehydrated Human Amnion Chorion Membrane (dHACM) vs. Control in the Treatment of Partial Thickness Burns.
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
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Treatment of Partial Thickness Burns
  • Other: Dehydrated Human Amnion/Chorion Membrane
    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).
    Other Name: dHACM
  • Device: Mepilex Ag
  • Active Comparator: Group 1
    Treatment 1 - dHACM plus Control Burn Area A Treatment 2 - Control Burn Area B
    Interventions:
    • Other: Dehydrated Human Amnion/Chorion Membrane
    • Device: Mepilex Ag
  • Active Comparator: Group 2
    Treatment 1 - dHACM plus Control Burn Area B Treatment 2 - Control Burn Area A
    Interventions:
    • Other: Dehydrated Human Amnion/Chorion Membrane
    • Device: Mepilex Ag
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
Same as current
December 2018
December 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

ll patients enrolled must meet all the following criteria:

  1. Patient with burn injury that meets all of the following requirements:

    1. Occurred within the last 48 hours
    2. Wound is thermal in nature
    3. Partial-thickness burn (burn extends through the epidermis and may penetrate into the dermis)
    4. Total body surface area (TBSA) of burn(s) is 2-20% for all subjects
    5. Burn area(s) located on smooth, flat surface
    6. 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)
  2. Age ≥ 12 months and ≤ 70 years

Exclusion Criteria:

Subjects meeting any of the following criteria will be excluded:

  1. Burns meeting any of the following criteria:

    1. Mechanism of injury was electrical, radiation, chemical or frostbite
    2. Wound is larger than 200 cm2
    3. Clinically infected burn (as judged by the investigator)
    4. Previous or planned treatment of the Burn Area(s) with any of the following:

      • Biological Skin Substitutes (including Apligraf®, Dermagraft®, etc.)
  2. Patient criteria that will make patient ineligible for enrollment:

    1. Ventilator dependence
    2. Active malignant disease or patient is less than 1 year disease-free
    3. Use of immunosuppressive agents, radiation or chemotherapy within the past 30 days
    4. Auto-immune disorders including Systemic Lupus Erythematosus (SLE), Fibromyalgia, Acquired Immunodeficiency Syndrome (AIDS) or Human Immunodeficiency Virus (HIV)
    5. 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
    6. Presence of any condition that is likely to compromise healing in the judgment of the Investigator
    7. 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)
    8. Patient has been on any investigational drug(s) or therapeutic device(s) in the last 30 days or any previous enrollment in this study
  3. Allergy or known sensitivity to any of the following:

    1. Aminoglycosides such as gentamicin sulfate and/or streptomycin sulfate
    2. Silver

Sexes Eligible for Study: All
12 Months to 70 Years   (Child, Adult, Older Adult)
No
Contact: Stan Harris 770-651-9223 sharris@mimedx.com
Contact: Kimberly Kot 770-651-9260 kkot@mimedx.com
United States
 
 
NCT02765737
EFBUR002
No
Not Provided
Plan to Share IPD: No
MiMedx Group, Inc.
MiMedx Group, Inc.
Not Provided
Study Director: Donald Fetterolf, MD Chief Medical Officer
MiMedx Group, Inc.
August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP