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

MiMedx Group, Inc.1 site in 1 country10 target enrollmentMay 2016

ConditionsPressure Ulcer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Pressure Ulcer
Sponsor: MiMedx Group, Inc.
Enrollment: 10
Locations: 1
Primary Endpoint: Healing Rate
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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

Registry

clinicaltrials.gov

Start Date

May 2016

End Date

May 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

MiMedx Group, Inc.

Responsible Party

Sponsor

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