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

NCT02765737 | Terminated

• 1 other identifier: EFBUR002
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 6

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

Conditions

Treatment of Partial Thickness Burns

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Reduction in pain

  3 weeks

Study Arms (2)

Group 1

ACTIVE COMPARATOR

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

Other: Dehydrated Human Amnion/Chorion Membrane; Device: Mepilex Ag

Group 2

ACTIVE COMPARATOR

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

Other: Dehydrated Human Amnion/Chorion Membrane; Device: Mepilex Ag

Interventions

Dehydrated Human Amnion/Chorion Membrane 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).

Also known as: dHACM

Group 1; Group 2

Mepilex Ag DEVICE

Group 1; Group 2

Eligibility Criteria

• Age: 12 Months - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• ll patients enrolled must meet all the following criteria:
• Patient with burn injury that meets all of the following requirements:
• Occurred within the last 48 hours
• Wound is thermal in nature
• Partial-thickness burn (burn extends through the epidermis and may penetrate into the dermis)
• Total body surface area (TBSA) of burn(s) is 2-20% for all subjects
• Burn area(s) located on smooth, flat surface
• 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)
• Age ≥ 12 months and ≤ 70 years

You may not qualify if:

• Subjects meeting any of the following criteria will be excluded:
• Burns meeting any of the following criteria:
• Mechanism of injury was electrical, radiation, chemical or frostbite
• Wound is larger than 200 cm2
• Clinically infected burn (as judged by the investigator)
• Previous or planned treatment of the Burn Area(s) with any of the following:
• Biological Skin Substitutes (including Apligraf®, Dermagraft®, etc.)
• Patient criteria that will make patient ineligible for enrollment:
• Ventilator dependence
• Active malignant disease or patient is less than 1 year disease-free
• Use of immunosuppressive agents, radiation or chemotherapy within the past 30 days
• Auto-immune disorders including Systemic Lupus Erythematosus (SLE), Fibromyalgia, Acquired Immunodeficiency Syndrome (AIDS) or Human Immunodeficiency Virus (HIV)
• 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
• Presence of any condition that is likely to compromise healing in the judgment of the Investigator
• 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)

Sponsors & Collaborators

• MiMedx Group, Inc.: lead

Study Sites (6)

Arizona Burn Center

Phoenix, Arizona, 85008, United States

Location

Keck School of Medicine

Los Angeles, California, 90032, United States

Location

University of San Diego Nedical Center

San Diego, California, 92103, United States

Location

St Elizabeth Reg Med Center

Lincoln, Nebraska, 68506, United States

Location

Bruce Cairns Surgery Burn Center

Chapel Hill, North Carolina, 27514, United States

Location

Drexel University

Philadelphia, Pennsylvania, 19140, United States

Location

Study Officials

• David Mason, MD

  Chief Medical Officer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2016
• First Posted: May 9, 2016
• Study Start: April 1, 2016
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: May 17, 2022

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)