RECRUITING
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Myriad™ Augmented Soft Tissue Reconstruction Registry
This is an observational study designed to evaluate the safety and clinical outcomes of Myriad™ in soft tissue reconstruction procedures. The study will enroll participants who are undergoing a surgical procedure, where the attending physician will use Myriad™ as part of the surgical intervention.
Conditions:
🦠 Abdominal Wound Dehiscence 🦠 Necrotizing Soft Tissue Infection 🦠 Lower Extremity Wound 🦠 Pilonidal Sinus 🦠 Anal Fistula 🦠 Hidradenitis Suppurativa 🦠 Pressure Injury
🗓️ Study Start (Actual) 10 January 2022
🗓️ Primary Completion (Estimated) January 2028
✅ Study Completion (Estimated) January 2029
👥 Enrollment (Estimated) 800
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Los Angeles, California, United States
📍 Fort Myers, Florida, United States
📍 Gainesville, Georgia, United States
📍 New Orleans, Louisiana, United States
📍 New Orleans, Louisiana, United States
📍 Baltimore, Maryland, United States
📍 Poughkeepsie, New York, United States
📍 Greensboro, North Carolina, United States
📍 Columbus, Ohio, United States
📍 West Reading, Pennsylvania, United States
More locations available...

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Willing and able to provide written informed consent and to comply with the requirements of Clinical Investigational Plan
    • * Male or female patients aged 18 years or above
    • * Patients where Matrix and/or Morcells were used as part of their soft tissue reconstruction procedure
    • * Subject that are willing and able to comply with all aspects of the treatment and evaluation schedule

    Exclusion Criteria:

    • * Patients with known sensitivity to ovine (sheep) derived material
    • * Patients with full thickness ('third degree') burns
    • * Patients with wounds with uncontrolled clinical infection (CDC Contamination Grade=4)
    • * Any medical condition or serious intercurrent illness that, in the opinion of the investigator, may make it undesirable for the patient to participate in the study
    • * Patient is currently participating or has participated in another clinical study within past 30 days prior to enrollment
    • * Pregnant or lactating women
    • * Any subject who, at the discretion of the Investigator, is not suitable for inclusion in the study
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 8 February 2022
  • First Submitted that Met QC Criteria 8 February 2022
  • First Posted 17 February 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 5 June 2024
  • Last Update Posted 7 June 2024
  • Last Verified June 2024
I'm interested ...!!