Myriad™ applied in conjunction with NPWTNPWT Alone
Myriad™ applied in conjunction with NPWT: Myriad™ applied in conjunction with NPWT ('Myriad+NPWT')
NPWT Alone: Control Arm: NPWT alone ('NPWT')
Study summary
Demonstrate faster tissue coverage of exposed structures using OFM in combination with negative pressure wound therapy (NPWT), versus NPWT alone
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Patients will be considered eligible for the study based on the following criteria:
* Willing and able to provide written informed consent and to comply with the requirements of the Clinical Investigational Plan
* Male or female patients aged 18 years or above
* Patient is requiring reconstruction of a full thickness soft tissue defect, that includes exposed structures (bone, tendon, or neurovascular), upper or lower extremity.
* Total defect size, range 25 to 800 cm2
Exclusion Criteria:
* Patients will be excluded from the study based on the following criteria:
* Patients with known sensitivity to ovine (sheep) derived material
* Pregnant or lactating females.
* Patients who are prisoners.
* Patients who are likely not to complete the study.
* Patients who, in the opinion of the Investigator, are unlikely to comply with the protocol.
* Patients currently participating in or have participated in another clinical study within the past 30 days prior to enrolment that at the discretion of the Investigator makes them unsuitable for inclusion in the study.
* Any subject who, at the discretion of the Investigator, is not suitable for inclusion in the study.
* Any medical condition, recent treatment or serious intercurrent illness that, in the opinion of the Investigator, may make it undesirable for the patient to participate in the study.
* Obesity (BMI\>45)
* Blood glucose ≥350 mg/dL at admission
* History of chronic peripheral vascular disease
* Current immunosuppression
* Recent neoadjuvant chemotherapy or radiotherapy
* Previous or concurrent application of a cell/tissue-based product (CTP, or skin substitute) at the wound site within 30 days of the Screening Visit
* Defect is a third degree burn
Primary outcome measure(s)
Tissue Coverage — Up to 56 days/ 8 week follow up Time (days) to complete tissue coverage of the exposed structure
Trial sites (2)
Facility
City
Region
Status
University of Colorado-Anschutz Medical Campus
Aurora
Colorado
Recruiting
The University of Texas Health Science Center at San Antonio
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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