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Recruiting NCT05243966

Myriad™ Augmented Soft Tissue Reconstruction Registry

Trial Parameters

Condition Abdominal Wound Dehiscence
Sponsor Aroa Biosurgery Limited
Study Type OBSERVATIONAL
Phase N/A
Enrollment 800
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2022-01-10
Completion 2028-01
Interventions
Myriad Matrix™ and Myriad Morcells™

Brief 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.

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 Invest

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