Myriad™ Augmented Soft Tissue Reconstruction Registry (MASTRR)

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: Hidradenitis Suppurativa; Anal Fistula; Pressure Injury; Pilonidal Sinus; Necrotizing Soft Tissue Infection; Abdominal Wound Dehiscence; Lower Extremity Wound
• Intervention / Treatment: Device: Myriad Matrix™ and Myriad Morcells™

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): 300

Contacts and Locations

• Study Contact: Name: Barnaby May, PhD; Phone Number: +64 21 056 9995; Email: barnaby.may@aroabio.com
• Study Contact Backup: Name: Brandon Bosque, DMP,CWSP; Email: Brandon.Bosque@aroabio.com

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Recruiting
      • Surgery Group LA
      • Contact: Yosef Nasseri, MD, FACS, FACRS; Phone Number: 310-861-7493
      • Principal Investigator: Yosef Nasseri, MD, FACS, FACRS
      • Principal Investigator: Moshe Barnajian, MD, FACRS
  • Florida
    • Fort Myers, Florida, United States, 33919
      • Recruiting
      • Associates in Medicine & Surgery
      • Contact: Patrick Martyka, DPM
      • Principal Investigator: Patrick Martyka, DPM
  • Georgia
    • Gainesville, Georgia, United States, 30501
      • Enrolling by invitation
      • Northeast Georgia Medical Center, Inc.
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Recruiting
      • University Medical Center
      • Contact: Alison Smith, MD, PhD; Phone Number: 504-903-9009; Email: asmi60@lsuhsc.edu
      • Principal Investigator: Alison Smith, MD, PhD
      • Sub-Investigator: Frank Lau, MD
      • Contact: Frank Lau, MD; Phone Number: 504-412-1240; Email: flau@lsuhsc.edu
    • 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
    • West Reading, Pennsylvania, United States, 19611
      • Enrolling by invitation
      • Tower Health Reading Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 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

How is the study designed?

Design Details

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

Number of groups / cohorts

1

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	Nature, frequency, and severity of adverse events	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time (weeks) to complete healing	When Myriad™ is used in soft tissue reinforcement the time to would closure will be recorded	Up to 52 weeks
Percentage of surgical complications	Reporting the incidence of infection, seroma/hematoma, dehiscence from surgical procedures	Up to 3 months
Time (weeks) to 100% granulation	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	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

• Sponsor: Aroa Biosurgery Limited
• Investigators: Study Chair: Tracee Short, MD, Short Consulting Group, LLC

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2022
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2026

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): October 17, 2023
• Last Update Submitted That Met QC Criteria: October 15, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Regenerative medicine; Extracellular matrix; Soft tissue reconstruction; Limb salvage; Soft tissue reinforcement; Wound reconstruction
• Additional Relevant MeSH Terms: Digestive System Diseases; Sweat Gland Diseases; Skin Diseases; Infections; Neoplasms; Cysts; Gastrointestinal Diseases; Intestinal Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Pathological Conditions, Anatomical; Rectal Diseases; Skin Diseases, Infectious; Suppuration; Skin Diseases, Bacterial; Intestinal Fistula; Digestive System Fistula; Wounds and Injuries; Fistula; Rectal Fistula; Soft Tissue Infections; Hidradenitis Suppurativa; Hidradenitis; Crush Injuries; Pilonidal Sinus
• 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