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.

Study Description

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

Condition or disease	Intervention/treatment	Phase
Treatment of Partial Thickness Burns	Other: Dehydrated Human Amnion/Chorion Membrane; Device: Mepilex Ag	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 23 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Dehydrated Human Amnion Chorion Membrane (dHACM) vs. Control in the Treatment of Partial Thickness Burns.
• Study Start Date: April 2016
• Actual Primary Completion Date: January 2019
• Actual Study Completion Date: January 2019

Arms and Interventions

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 Name: 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 Name: dHACM; Device: Mepilex Ag

Outcome Measures

Primary Outcome Measures :

1. Healing Rate [ Time Frame: 3 weeks ]
   95% epitheliazation as assesses by the investigator
2. 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.

Secondary Outcome Measures :

1. 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)

Eligibility Criteria

• Ages Eligible for Study: 12 Months to 70 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

      -

Contacts and Locations

Locations

United States, Arizona

Arizona Burn Center

Phoenix, Arizona, United States, 85008

United States, California

Keck School of Medicine

Los Angeles, California, United States, 90032

University of San Diego Nedical Center

San Diego, California, United States, 92103

United States, Nebraska

St Elizabeth Reg Med Center

Lincoln, Nebraska, United States, 68506

United States, North Carolina

Bruce Cairns Surgery Burn Center

Chapel Hill, North Carolina, United States, 27514

United States, Pennsylvania

Drexel University

Philadelphia, Pennsylvania, United States, 19140

Sponsors and Collaborators

MiMedx Group, Inc.

Investigators

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

More Information

• Responsible Party: MiMedx Group, Inc.
• ClinicalTrials.gov Identifier: NCT02765737
• Other Study ID Numbers: EFBUR002
• First Posted: May 9, 2016
• Last Update Posted: May 17, 2022
• Last Verified: November 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Dehydration; Burns; Wounds and Injuries; Water-Electrolyte Imbalance; Metabolic Diseases; Pathologic Processes