Pressure Ulcer
Conditions
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
Interventions
OTHERdHACM
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)
Sponsors
MiMedx Group, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Healing Rate | 8 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 8 Weeks | — |
| Quality of Life | 8 Weeks | SF-36 Health Survey |
Countries
United States
Outcome results
None listed