Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT02765737
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02765737
Recruitment Status : Terminated (Slow enrollment, issues with inclusion/exclusion and choice of control)
First Posted : May 9, 2016
Last Update Posted : May 17, 2022
Sponsor:
Information provided by (Responsible Party):
MiMedx Group, Inc.

Tracking Information
First Submitted Date  ICMJE May 5, 2016
First Posted Date  ICMJE May 9, 2016
Last Update Posted Date May 17, 2022
Study Start Date  ICMJE April 2016
Actual Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 9, 2020)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 6, 2016)
  • 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 9, 2020)
Reduction in pain [ Time Frame: 3 weeks ]
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)
Original Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2016)
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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dehydrated Human Amnion Chorion Membrane (dHACM) vs. Control in the Treatment of Partial Thickness Burns.
Official Title  ICMJE Dehydrated Human Amnion Chorion Membrane (dHACM) vs. Control in the Treatment of Partial Thickness Burns.
Brief 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Treatment of Partial Thickness Burns
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 2, 2020)
23
Original Estimated Enrollment  ICMJE
 (submitted: May 6, 2016)
60
Actual Study Completion Date  ICMJE January 2019
Actual Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

      -

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Months to 70 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02765737
Other Study ID Numbers  ICMJE EFBUR002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party MiMedx Group, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE MiMedx Group, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: David Mason, MD Chief Medical Officer
PRS Account MiMedx Group, Inc.
Verification Date November 2020

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