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

• ClinicalTrials.gov Identifier: NCT02765737
• Recruitment Status: Terminated
• First Posted: May 9, 2016
• Last Update Posted: May 17, 2022
• Sponsor: MiMedx Group, Inc.
• Information provided by (Responsible Party): MiMedx Group, Inc.

Tracking Information

• First Submitted Date: May 5, 2016
• First Posted Date: May 9, 2016
• Last Update Posted Date: May 17, 2022
• Study Start Date: April 2016
• Actual Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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.

Current Secondary Outcome Measures (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 (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: Dehydrated Human Amnion Chorion Membrane (dHACM) vs. Control in the Treatment of Partial Thickness Burns.
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Treatment of Partial Thickness Burns

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: November 2, 2020): 23
• Original Estimated Enrollment (submitted: May 6, 2016): 60
• Actual Study Completion Date: January 2019
• Actual Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 12 Months to 70 Years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02765737
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Current Responsible Party: MiMedx Group, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: MiMedx Group, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: David Mason, MD; Chief Medical Officer

• PRS Account: MiMedx Group, Inc.
• Verification Date: November 2020