NCT02861560CompletedNot Applicable
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
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- MiMedx Group, Inc.
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Healing Rate
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 16 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
dHACM
Experimental
Dehydrated human amnion/chorion membrane (dHACM)
Intervention: dHACM (Other)
Outcomes
Primary Outcomes
Healing Rate
Time Frame: 8 weeks
Secondary Outcomes
- Quality of Life(8 Weeks)
- Adverse Events(8 Weeks)
Investigators
Study Sites (1)
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