Myriad™ Augmented Soft Tissue Reconstruction Registry

Recruiting now

Conditions studied: Abdominal Wound Dehiscence, Necrotizing Soft Tissue Infection, Lower Extremity Wound, Pilonidal Sinus, Anal Fistula, Hidradenitis Suppurativa, Pressure Injury

In brief

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.

Key facts

Study ID

NCT05243966

Run by

Aroa Biosurgery Limited

People needed

800

Starts

2022-01-10

Expected to finish

2029-01-01

Last updated by the study team

2026-07-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• The Medical College of Wisconsin — Milwaukee, Wisconsin, United States (enrolling)
• Asencion Sacred Heart — Pensacola, Florida, United States (enrolling)
• Northeast Georgia Medical Center, Inc. — Gainesville, Georgia, United States (enrolling)
• University Medical Center — New Orleans, Louisiana, United States (enrolling)
• Sinai Hospital of Baltimore — Baltimore, Maryland, United States (enrolling)
• Lancaster General Hospital — Lancaster, Pennsylvania, United States (enrolling)
• University of IOWA Health Care — Iowa City, Iowa, United States
• Ohio State University Wexner Medical Center — Columbus, Ohio, United States
• Ochsner Baptist Medical Center — New Orleans, Louisiana, United States
• Tower Health Reading Hospital — West Reading, Pennsylvania, United States
• The Diane & Bruce Halle Arizona Burn Center at Valleywise Health — Phoenix, Arizona, United States
• Surgery Group LA — Los Angeles, California, United States
• Associates in Medicine & Surgery — Fort Myers, Florida, United States
• Nuvance Health Vassar Brothers Medical Center — Poughkeepsie, New York, United States
• Moses H Cone Memorial Hospital Operating Corporation — Greensboro, North Carolina, United States

Full record on ClinicalTrials.gov

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