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

Completed · Not applicable

Conditions studied: Pressure Ulcer

In brief

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

Key facts

Study ID

NCT02861560

Run by

MiMedx Group, Inc.

People needed

10

Starts

2016-05-01

Expected to finish

2018-05-01

Last updated by the study team

2018-08-24

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Shepherd Spine Center — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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