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Trial record 43 of 129 for:    Recruiting, Not yet recruiting, Available Studies | "Burns"

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

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ClinicalTrials.gov Identifier: NCT02765737
Recruitment Status : Recruiting
First Posted : May 9, 2016
Last Update Posted : March 6, 2017
Sponsor:
Information provided by (Responsible Party):
MiMedx Group, Inc.

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 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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 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
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns Dehydration
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Healing Rate [ Time Frame: 3 weeks ]
  2. Freedom from Scarring [ Time Frame: 3 Months ]

Secondary Outcome Measures :
  1. Reduction in pain [ Time Frame: 3 weeks ]


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Ages Eligible for Study:   12 Months to 70 Years   (Child, Adult, Senior)
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02765737


Contacts
Contact: Stan Harris 770-651-9223 sharris@mimedx.com
Contact: Kimberly Kot 770-651-9260 kkot@mimedx.com

Locations
United States, California
Keck School of Medicine Recruiting
Los Angeles, California, United States, 90032
Contact: Pui Yan         
United States, Pennsylvania
Drexel University Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Janille Diaz         
Sponsors and Collaborators
MiMedx Group, Inc.
Investigators
Study Director: Donald Fetterolf, MD Chief Medical Officer

Responsible Party: MiMedx Group, Inc.
ClinicalTrials.gov Identifier: NCT02765737     History of Changes
Other Study ID Numbers: EFBUR002
First Posted: May 9, 2016    Key Record Dates
Last Update Posted: March 6, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Burns
Wounds and Injuries