Registry of Myriad™ Utilization in Soft Tissue Reconstruction Procedures
Aroa Biosurgery Limited
Summary
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.
Description
This is an observational, multi-center, single arm, Phase IV study, designed to evaluate the safety and clinical outcomes of Matrix and Morcells in soft tissue reconstruction procedures. The study is a registry study and will enroll participants who are undergoing a surgical procedure, and where the attending physician will use Myriad Matrix™ and/or Morcells™ as part of the surgical intervention. Participants enrolled in the study will be undergoing a range of surgical procedures involving the reconstruction of soft tissues, including but not limited to: * Abdominal dehiscence * Necrotizing…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 infe…
Interventions
- DeviceMyriad Matrix™ and Myriad Morcells™
Ovine forestomach matrix sheet graft and morselized extracellular matrix
Locations (13)
- Surgery Group LALos Angeles, California
- Associates in Medicine & SurgeryFort Myers, Florida
- Asencion Sacred HeartPensacola, Florida
- Northeast Georgia Medical Center, Inc.Gainesville, Georgia
- University Medical CenterNew Orleans, Louisiana
- Ochsner Baptist Medical CenterNew Orleans, Louisiana