Myriad™ Augmented Soft Tissue Reconstruction Registry

NCT05243966 | Recruiting FDA Device

• 1 other identifier: CIP.SUR.001
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 13

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.

Conditions

Abdominal Wound Dehiscence; Necrotizing Soft Tissue Infection; Lower Extremity Wound; Pilonidal Sinus; Anal Fistula; Hidradenitis Suppurativa; Pressure Injury

Keywords

Soft tissue reconstruction; Limb salvage; Extracellular matrix; Soft tissue reinforcement; Wound reconstruction; Regenerative medicine

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with treatment emergent adverse events during the study

  Nature, frequency, and severity of adverse events

  3 years

Secondary Outcomes (4)

• Time (weeks) to complete healing

  Up to 52 weeks

• Percentage of surgical complications

  Up to 3 months

• Time (weeks) to 100% granulation

  Up to 3 months

• Percentage of split thickness skin graft take at 1 week post Matrix™ application

  1 week post application

Study Arms (1)

Myriad™

Ovine forestomach matrix sheet graft and morselized extracellular matrix

Device: Myriad Matrix™ and Myriad Morcells™

Interventions

Myriad Matrix™ and Myriad Morcells™ DEVICE

Ovine forestomach matrix sheet graft and morselized extracellular matrix

Myriad™

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aroa Biosurgery Limited: lead

Study Sites (13)

Surgery Group LA

Los Angeles, California, 90048, United States

COMPLETED

Associates in Medicine & Surgery

Fort Myers, Florida, 33919, United States

ACTIVE NOT RECRUITING

Asencion Sacred Heart

Pensacola, Florida, 32504, United States

RECRUITING

Northeast Georgia Medical Center, Inc.

Gainesville, Georgia, 30501, United States

RECRUITING

University Medical Center

New Orleans, Louisiana, 70112, United States

RECRUITING

Ochsner Baptist Medical Center

New Orleans, Louisiana, 70115, United States

ENROLLING BY INVITATION

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215, United States

RECRUITING

Nuvance Health Vassar Brothers Medical Center

Poughkeepsie, New York, 12601, United States

ENROLLING BY INVITATION

Moses H Cone Memorial Hospital Operating Corporation

Greensboro, North Carolina, 27401-1004, United States

ENROLLING BY INVITATION

Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

ENROLLING BY INVITATION

Lancaster General Hospital

Lancaster, Pennsylvania, 17601, United States

RECRUITING

Tower Health Reading Hospital

West Reading, Pennsylvania, 19611, United States

ENROLLING BY INVITATION

The Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

MeSH Terms

Conditions

Pilonidal Sinus; Rectal Fistula; Hidradenitis Suppurativa; Pressure Ulcer

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Intestinal Fistula; Digestive System Fistula; Digestive System Diseases; Intestinal Diseases; Gastrointestinal Diseases; Rectal Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases; Skin Ulcer

Study Officials

• Tracee Short, MD

  Short Consulting Group, LLC

  STUDY CHAIR

Central Study Contacts

Barnaby May, PhD

CONTACT

+64 21 056 9995; barnaby.may@aroa.com

Brandon Bosque, DMP,CWSP

CONTACT

Brandon.Bosque@aroa.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: February 17, 2022
• Study Start: January 10, 2022
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: February 19, 2026

Record last verified: 2026-01

Locations

US (13)