Myriad™ Augmented Soft Tissue Reconstruction Registry (MASTRR)

February 17, 2026 updated by: Aroa Biosurgery Limited

Registry of Myriad™ Utilization in Soft Tissue Reconstruction Procedures

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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:

  • Abdominal dehiscence
  • Necrotizing soft tissue infection (NSTI)
  • Lower extremity complex non-healing wounds (limb salvage)
  • Pilonidal sinus disease
  • Anal fistula
  • Hidradenitis suppurativa reconstruction
  • 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 Type

Observational

Enrollment (Estimated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Completed
        • Surgery Group LA
    • Florida
      • Fort Myers, Florida, United States, 33919
        • Active, not recruiting
        • Associates in Medicine & Surgery
      • Pensacola, Florida, United States, 32504
        • Recruiting
        • Asencion Sacred Heart
        • Contact:
        • Principal Investigator:
          • Kyle J. Leneweaver, DO
    • Georgia
      • Gainesville, Georgia, United States, 30501
        • Recruiting
        • Northeast Georgia Medical Center, Inc.
        • Contact:
        • Principal Investigator:
          • William M Vassy, MD
        • Sub-Investigator:
          • Michael T Cormican, MD
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • University Medical Center
        • Contact:
        • Principal Investigator:
          • Alison Smith, MD, PhD
        • Sub-Investigator:
          • Frank Lau, MD
        • Contact:
      • New Orleans, Louisiana, United States, 70115
        • Enrolling by invitation
        • Ochsner Baptist Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21215
        • Recruiting
        • Sinai Hospital of Baltimore
        • Contact:
          • Research Coordinator
          • Phone Number: 443-220-1438
        • Principal Investigator:
          • Joshua Wolf, MD
    • New York
      • Poughkeepsie, New York, United States, 12601
        • Enrolling by invitation
        • Nuvance Health Vassar Brothers Medical Center
    • North Carolina
      • Greensboro, North Carolina, United States, 27401-1004
        • Enrolling by invitation
        • Moses H Cone Memorial Hospital Operating Corporation
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Enrolling by invitation
        • Ohio State University Wexner Medical Center
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17601
      • West Reading, Pennsylvania, United States, 19611
        • Enrolling by invitation
        • Tower Health Reading Hospital
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • The Medical College of Wisconsin
        • Contact:
        • Contact:
          • Jacob Peschman, MD
          • Phone Number: 414-955-1751

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants with treatment emergent adverse events during the study
Time Frame: 3 years
Nature, frequency, and severity of adverse events
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time (weeks) to complete healing
Time Frame: Up to 52 weeks
When Myriad™ is used in soft tissue reinforcement the time to would closure will be recorded
Up to 52 weeks
Percentage of surgical complications
Time Frame: Up to 3 months
Reporting the incidence of infection, seroma/hematoma, dehiscence from surgical procedures
Up to 3 months
Time (weeks) to 100% granulation
Time Frame: Up to 3 months
Where applicable, when Myriad™ is used for dermal regeneration, the time until full graft integration will be recorded
Up to 3 months
Percentage of split thickness skin graft take at 1 week post Matrix™ application
Time Frame: 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
1 week post application

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aroa Biosurgery Limited

Investigators

  • Study Chair: Tracee Short, MD, Short Consulting Group, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2022

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2029

Study Registration Dates

First Submitted

February 8, 2022

First Submitted That Met QC Criteria

February 8, 2022

First Posted (Actual)

February 17, 2022

Study Record Updates

Last Update Posted (Actual)

February 19, 2026

Last Update Submitted That Met QC Criteria

February 17, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIP.SUR.001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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