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.
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
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
The study is being carried out at approximately 10 sites in the U.S. Across all sites, about 300 individuals will participate in the study where the Investigator is planning to utilize Myriad™ as a part of their surgical procedure.
Case-only
Prospective
Myriad Matrix™ and Myriad Morcells™
DeviceOvine forestomach matrix sheet graft and morselized extracellular matrix
Proportion of participants with treatment emergent adverse events during the study
Nature, frequency, and severity of adverse events
Time (weeks) to complete healing
When Myriad™ is used in soft tissue reinforcement the time to would closure will be recorded
Percentage of surgical complications
Reporting the incidence of infection, seroma/hematoma, dehiscence from surgical procedures
Time (weeks) to 100% granulation
Where applicable, when Myriad™ is used for dermal regeneration, the time until full graft integration will be recorded
Percentage of split thickness skin graft take at 1 week post Matrix™ application
Where applicable, when Myriad™ is used for dermal regeneration and a split thickness skin graft is used the percentage of graft take at 1 week will be recorded
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