Recruiting

Observational Study

Sponsor:

Aroa Biosurgery Limited

Code:

NCT05243966

Conditions

Abdominal Wound Dehiscence

Necrotizing Soft Tissue Infection

Lower Extremity Wound

Pilonidal Sinus

Anal Fistula

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Myriad Matrix™ and Myriad Morcells™

Study Details

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

Study ID

NCT05243966

Start date

Jan 10, 2022

Status verified date

Jan, 2026

Completion date

Jan, 2029

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

800 participants

Anticipated

Interventions and Outcome Measures

Arms

Myriad™

Ovine forestomach matrix sheet graft and morselized extracellular matrix

Interventions

Myriad Matrix™ and Myriad Morcells™

Ovine forestomach matrix sheet graft and morselized extracellular matrix

Primary outcome measure

  • Proportion of participants with treatment emergent adverse events during the study [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Barnaby May, PhD

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

Brandon Bosque, DMP,CWSP

Brandon.Bosque@aroa.com

Locations

Asencion Sacred Heart

Recruiting

Pensacola, Florida, United States, 32504

Contacts

Kymberly Palmer

813-843-1398Kymberly.palmer@ascension.org

Principal Investigator:

Kyle J. Leneweaver, DO

Northeast Georgia Medical Center, Inc.

Recruiting

Gainesville, Georgia, United States, 30501

Contacts

Emily Murdoch

(770)-219-3438Emily.murdoch@nghs.com

Principal Investigator:

William M Vassy, MD

University Medical Center

Recruiting

New Orleans, Louisiana, United States, 70112

Contacts

Alison Smith, MD, PhD

504-903-9009asmi60@lsuhsc.edu

Frank Lau, MD

504-412-1240flau@lsuhsc.edu

Principal Investigator:

Alison Smith, MD, PhD

Sinai Hospital of Baltimore

Recruiting

Baltimore, Maryland, United States, 21215

Contacts

Research Coordinator

443-220-1438

Principal Investigator:

Joshua Wolf, MD

Lancaster General Hospital

Recruiting

Lancaster, Pennsylvania, United States, 17601

Contacts

Medoza Ameen

223-221-1177Medoza.ameen@pennmedicine.upenn.edu

Principal Investigator:

Lindsey Perea, DO

The Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Thomas Carver, MD

414-955-1751tcarver@mcw.edu

Jacob Peschman, MD

414-955-1751

More Information

Sponsor

Aroa Biosurgery Limited

Last update posted

Jul 15, 2026

Last verified

Jan, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-07. This information was provided to ClinicalTrials.gov by Aroa Biosurgery Limited on 2026-07-15.