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

NCT ID: NCT02765737

Last Updated: 2022-05-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2019-01-31

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

Conditions

Treatment of Partial Thickness Burns

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1

Treatment 1 - dHACM plus Control Burn Area A Treatment 2 - Control Burn Area B

Group Type: ACTIVE_COMPARATOR

Dehydrated Human Amnion/Chorion Membrane

Intervention Type: OTHER

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).

Mepilex Ag

Intervention Type: DEVICE

Group 2

Treatment 1 - dHACM plus Control Burn Area B Treatment 2 - Control Burn Area A

Group Type: ACTIVE_COMPARATOR

Dehydrated Human Amnion/Chorion Membrane

Intervention Type: OTHER

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).

Mepilex Ag

Intervention Type: DEVICE

Interventions

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).

Intervention Type: OTHER

Mepilex Ag

Intervention Type: DEVICE

Other Intervention Names

dHACM

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

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• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MiMedx Group, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Mason, MD

Role: STUDY_DIRECTOR

Chief Medical Officer

Locations

Arizona Burn Center

Phoenix, Arizona, United States

Keck School of Medicine

Los Angeles, California, United States

University of San Diego Nedical Center

San Diego, California, United States

St Elizabeth Reg Med Center

Lincoln, Nebraska, United States

Bruce Cairns Surgery Burn Center

Chapel Hill, North Carolina, United States

Drexel University

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

EFBUR002

Identifier Type: -

Identifier Source: org_study_id