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 (partial thickness burns) as assessed by time to healing and scarring

Study Overview

• Status: Terminated
• Conditions: Treatment of Partial Thickness Burns
• Intervention / Treatment: Other: Dehydrated Human Amnion/Chorion Membrane; Device: Mepilex Ag

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
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85008
      • Arizona Burn Center
  • California
    • Los Angeles, California, United States, 90032
      • Keck School of Medicine
    • San Diego, California, United States, 92103
      • University of San Diego Nedical Center
  • Nebraska
    • Lincoln, Nebraska, United States, 68506
      • St Elizabeth Reg Med Center
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • Bruce Cairns Surgery Burn Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Drexel University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 70 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

      -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1; Treatment 1 - dHACM plus Control Burn Area A Treatment 2 - Control Burn Area B	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 Names: dHACM; Device: Mepilex Ag
Active Comparator: Group 2; Treatment 1 - dHACM plus Control Burn Area B Treatment 2 - Control Burn Area A	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 Names: dHACM; Device: Mepilex Ag

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healing Rate	95% epitheliazation as assesses by the investigator	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.	3 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	3 weeks

Collaborators and Investigators

• Sponsor: MiMedx Group, Inc.

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): January 1, 2019
• Study Completion (Actual): January 1, 2019

Study Registration Dates

• First Submitted: May 5, 2016
• First Submitted That Met QC Criteria: May 6, 2016
• First Posted (Estimate): May 9, 2016

Study Record Updates

• Last Update Posted (Actual): May 17, 2022
• Last Update Submitted That Met QC Criteria: May 10, 2022
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Wounds and Injuries; Water-Electrolyte Imbalance; Burns; Dehydration
• Other Study ID Numbers: EFBUR002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No