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Case Series of Weekly Applications of dHACM in Treatment of Pressure Ulcers

Primary Purpose

Pressure Ulcer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
dHACM
Sponsored by
MiMedx Group, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pressure Ulcer

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Index ulcer characteristics:

    1. Ulcer present for ≥ 30 days (Day 0)
    2. Index ulcer is located spine, lower back or buttocks
    3. Index ulcer area after debridement is ≥ 2 cm² and ≤ 25 cm² at the randomization visit
    4. Ulcer must be Stage II or III as determined by the National Pressure Ulcer Advisory Panel (NPUAP) pressure ulcer staging system
  2. Subject criteria must include:

    1. Age 16 or older
    2. The subject is willing and able to provide informed consent and participate in all procedures and follow-up evaluations necessary to complete the study (minors will provide assent with consent provided by parent)

Exclusion Criteria:

  1. Index ulcer characteristics that will make subject ineligible for enrollment:

    1. Stage I or IV ulcers as determined by NPUAP pressure ulcer staging system
    2. Signs and symptoms of local infection
    3. Previous surgical procedure performed at site
    4. Known or suspected local skin malignancy at index ulcer site
    5. Prior radiation therapy treatment at the index ulcer site
  2. Subject criteria that will make subject ineligible for enrollment:

    1. Presence of other diseases which, in the Opinion of the Investigator, may result in allograft failure or has experienced graft failure in the past (examples include: immune system disorders including Systemic Lupus Erythematosus (SLE), Fibromyalgia, Acquired Immunodeficiency Syndrome (AIDS) or HIV)
    2. Currently taking medications which in the opinion of the investigator may affect graft incorporation
    3. Allergy or known sensitivity to Aminoglycosides such as gentamicin sulfate and/or streptomycin sulfate
    4. Any condition(s) that in the opinion of the investigator may seriously compromises the subject's ability to participate in this study. Examples include: known history of poor adherence with medical treatment, current drug or alcohol abuse or a medical/psychiatric condition
    5. 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)
    6. Subjects currently enrolled in this study (i.e. concurrent enrollment in the study is prohibited)
    7. Subject has used any investigational drug(s) or therapeutic device(s) within 30 days preceding screening.
    8. Any pathology that would limit the blood supply and compromise healing
    9. Subject is a prisoner

Sites / Locations

  • Shepherd Spine Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

dHACM

Arm Description

Dehydrated human amnion/chorion membrane (dHACM)

Outcomes

Primary Outcome Measures

Healing Rate

Secondary Outcome Measures

Adverse Events
Quality of Life
SF-36 Health Survey

Full Information

First Posted
August 5, 2016
Last Updated
August 22, 2018
Sponsor
MiMedx Group, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02861560
Brief Title
Case Series of Weekly Applications of dHACM in Treatment of Pressure Ulcers
Official Title
A Case Series to Investigate the Safety and Efficacy of Weekly Application of Dehydrated Human Amnion/Chorion Membrane (dHACM) in the Treatment of Pressure Ulcers
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
May 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MiMedx Group, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
A prospective case series investigating the efficacy and safety of dehydrated human amnion/chorion membrane (dHACM) in the treatment of patients with Stage II or III pressure ulcers

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Ulcer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
dHACM
Arm Type
Experimental
Arm Description
Dehydrated human amnion/chorion membrane (dHACM)
Intervention Type
Other
Intervention Name(s)
dHACM
Intervention Description
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)
Primary Outcome Measure Information:
Title
Healing Rate
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Adverse Events
Time Frame
8 Weeks
Title
Quality of Life
Description
SF-36 Health Survey
Time Frame
8 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Index ulcer characteristics: Ulcer present for ≥ 30 days (Day 0) Index ulcer is located spine, lower back or buttocks Index ulcer area after debridement is ≥ 2 cm² and ≤ 25 cm² at the randomization visit Ulcer must be Stage II or III as determined by the National Pressure Ulcer Advisory Panel (NPUAP) pressure ulcer staging system Subject criteria must include: Age 16 or older The subject is willing and able to provide informed consent and participate in all procedures and follow-up evaluations necessary to complete the study (minors will provide assent with consent provided by parent) Exclusion Criteria: Index ulcer characteristics that will make subject ineligible for enrollment: Stage I or IV ulcers as determined by NPUAP pressure ulcer staging system Signs and symptoms of local infection Previous surgical procedure performed at site Known or suspected local skin malignancy at index ulcer site Prior radiation therapy treatment at the index ulcer site Subject criteria that will make subject ineligible for enrollment: Presence of other diseases which, in the Opinion of the Investigator, may result in allograft failure or has experienced graft failure in the past (examples include: immune system disorders including Systemic Lupus Erythematosus (SLE), Fibromyalgia, Acquired Immunodeficiency Syndrome (AIDS) or HIV) Currently taking medications which in the opinion of the investigator may affect graft incorporation Allergy or known sensitivity to Aminoglycosides such as gentamicin sulfate and/or streptomycin sulfate Any condition(s) that in the opinion of the investigator may seriously compromises the subject's ability to participate in this study. Examples include: known history of poor adherence with medical treatment, current drug or alcohol abuse or a medical/psychiatric condition 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) Subjects currently enrolled in this study (i.e. concurrent enrollment in the study is prohibited) Subject has used any investigational drug(s) or therapeutic device(s) within 30 days preceding screening. Any pathology that would limit the blood supply and compromise healing Subject is a prisoner
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald Fetterolf, MD
Organizational Affiliation
Chief Medical Officer
Official's Role
Study Director
Facility Information:
Facility Name
Shepherd Spine Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Case Series of Weekly Applications of dHACM in Treatment of Pressure Ulcers

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