MASTRR: Myriad™ Augmented Soft Tissue Reconstruction Registry
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
This is an observational, multi-center, single arm, Phase IV study, designed to evaluate the safety and clinical outcomes of Matrix and Morcells in soft tissue reconstruction procedures.
The study is a registry study and will enroll participants who are undergoing a surgical procedure, and where the attending physician will use Myriad Matrix™ and/or Morcells™ as part of the surgical intervention.
Participants enrolled in the study will be undergoing a range of surgical procedures involving the reconstruction of soft tissues, including but not limited to:
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Abdominal dehiscence
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Necrotizing soft tissue infection (NSTI)
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Lower extremity complex non-healing wounds (limb salvage)
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Pilonidal sinus disease
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Anal fistula
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Hidradenitis suppurativa reconstruction
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Pressure injury reconstruction
Other procedure types may be included at the discretion of the Investigator/Research Team.
Participants that are being enrolled in the study would otherwise be undergoing their surgical procedure with either of the Myriad™ devices as part of Standard of Care (SoC).
The pre-operative care and preparation of the surgical site (prior to the application of Myriad™ devices) shall be undertaken at the discretion of the attending physician and per their institutional protocols and procedures. Surgical technique for the participants reconstruction is at the discretion of the attending physician. Use of Myriad Matrix™ or Morcells as part of the surgery shall be per the products Instructions for Use. Myriad Matrix™ devices may be implanted or used for dermal regeneration as part of the participants surgical procedure. Myriad Morcells™ may be used for dermal regeneration and in combination with the Myriad Matrix™ devices. The participants post-operative care is at the discretion of the attending physician.
Early and late-stage healing outcomes will be assessed as part of the study and as part of standard of care.
Through the course of treatment and following up care de-identified patient data (quantitative qualitative assessment measures and digital images) will be captured and from the basis of the registry dataset.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Myriad™ Ovine forestomach matrix sheet graft and morselized extracellular matrix |
Device: Myriad Matrix™ and Myriad Morcells™
Ovine forestomach matrix sheet graft and morselized extracellular matrix
|
Outcome Measures
Primary Outcome Measures
- Proportion of participants with treatment emergent adverse events during the study [3 years]
Nature, frequency, and severity of adverse events
Secondary Outcome Measures
- Time (weeks) to complete healing [Up to 52 weeks]
When Myriad™ is used in soft tissue reinforcement the time to would closure will be recorded
- Percentage of surgical complications [Up to 3 months]
Reporting the incidence of infection, seroma/hematoma, dehiscence from surgical procedures
- Time (weeks) to 100% granulation [Up to 3 months]
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 [1 week post 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Willing and able to provide written informed consent and to comply with the requirements of Clinical Investigational Plan
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Male or female patients aged 18 years or above
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Patients where Matrix and/or Morcells were used as part of their soft tissue reconstruction procedure
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Subject that are willing and able to comply with all aspects of the treatment and evaluation schedule
Exclusion Criteria:
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Patients with known sensitivity to ovine (sheep) derived material
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Patients with full thickness ('third degree') burns
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Patients with wounds with uncontrolled clinical infection (CDC Contamination Grade=4)
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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
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Patient is currently participating or has participated in another clinical study within past 30 days prior to enrollment
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Pregnant or lactating women
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Any subject who, at the discretion of the Investigator, is not suitable for inclusion in the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Surgery Group LA | Los Angeles | California | United States | 90048 |
| 2 | University Medical Center | New Orleans | Louisiana | United States | 70112 |
| 3 | Ochsner Baptist Medical Center | New Orleans | Louisiana | United States | 70115 |
Sponsors and Collaborators
- Aroa Biosurgery Limited
Investigators
- Study Chair: Abigail Chaffin, MD, FACS, CWSP, FAPWCA, Tulane University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CIP.SUR.001