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Myriad™ Augmented Soft Tissue Reconstruction Registry

RECRUITINGSponsored by Aroa Biosurgery Limited
Actively Recruiting
SponsorAroa Biosurgery Limited
Started2022-01-10
Est. completion2028-01
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations13 sites

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

Age: 18 Years+Healthy volunteers accepted
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

Conditions8

Abdominal Wound DehiscenceAnal FistulaCancerHidradenitis SuppurativaLower Extremity WoundNecrotizing Soft Tissue InfectionPilonidal SinusPressure Injury

Locations13 sites

Surgery Group LA
Los Angeles, California, 90048
Associates in Medicine & Surgery
Fort Myers, Florida, 33919
Asencion Sacred Heart
Pensacola, Florida, 32504
Kymberly Palmer813-843-1398Kymberly.palmer@ascension.org
Northeast Georgia Medical Center, Inc.
Gainesville, Georgia, 30501
Emily Murdoch(770)-219-3438Emily.murdoch@nghs.com
University Medical Center
New Orleans, Louisiana, 70112
Alison Smith, MD, PhD504-903-9009asmi60@lsuhsc.edu

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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