Myriad™ Augmented Soft Tissue Reconstruction Registry

Launched by AROA BIOSURGERY LIMITED · Feb 8, 2022

Keywords

ClinConnect Summary

The Myriad™ Augmented Soft Tissue Reconstruction Registry is a clinical trial that aims to understand how safe and effective the Myriad™ product is when used in surgeries for various types of wounds, such as those caused by infections or injuries. This study is currently recruiting participants who are 18 years or older and are undergoing certain surgical procedures where Myriad™ will be used. To join the study, individuals must be able to give their consent and follow the treatment plan, and they should not have any serious health conditions that could affect their participation.

If you or a loved one is eligible and chooses to participate, you can expect to be part of an observational study, which means that while you receive treatment, researchers will closely monitor your health and the results of the surgery. This trial is open to all genders, and while it aims to gather important information about the use of Myriad™, it does not allow individuals with certain medical conditions, such as severe infections or burns, to participate. Overall, the study hopes to gather valuable information that could help improve future surgical treatments for patients with complex wound issues.

Gender

ALL

Eligibility criteria

• 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