Myriad™ Augmented Soft Tissue Reconstruction Registry

Hidradenitis Suppurativa Clinical Trial

— MASTRR  

Official title:

Registry of Myriad™ Utilization in Soft Tissue Reconstruction Procedures

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05243966
• Other study ID #: CIP.SUR.001
• Status: Recruiting
• Start date: January 10, 2022
• Est. completion date: January 2029

Study information

• Verified date: June 2024
• Source: Aroa Biosurgery Limited
• Contact: Barnaby May, PhD
• Phone: +64 21 056 9995
• Email: barnaby.may[@]aroabio.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: January 2029
• Est. primary completion date: January 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anal Fistula
• Crush Injuries
• Fistula
• Hidradenitis
• Hidradenitis Suppurativa
• Lower Extremity Wound
• Necrotizing Soft Tissue Infection
• Pilonidal Sinus
• Pressure Injury
• Pressure Ulcer
• Rectal Fistula
• Soft Tissue Infections
• Wounds and Injuries

Intervention

Device:
• Myriad Matrix™ and Myriad Morcells™
Ovine forestomach matrix sheet graft and morselized extracellular matrix

Locations

Country	Name	City	State
United States	Sinai Hospital of Baltimore	Baltimore	Maryland
United States	Ohio State University Wexner Medical Center	Columbus	Ohio
United States	Associates in Medicine & Surgery	Fort Myers	Florida
United States	Northeast Georgia Medical Center, Inc.	Gainesville	Georgia
United States	Moses H Cone Memorial Hospital Operating Corporation	Greensboro	North Carolina
United States	Surgery Group LA	Los Angeles	California
United States	Ochsner Baptist Medical Center	New Orleans	Louisiana
United States	University Medical Center	New Orleans	Louisiana
United States	Nuvance Health Vassar Brothers Medical Center	Poughkeepsie	New York
United States	Tower Health Reading Hospital	West Reading	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Aroa Biosurgery Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants with treatment emergent adverse events during the study	Nature, frequency, and severity of adverse events	3 years
Secondary	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
Secondary	Percentage of surgical complications	Reporting the incidence of infection, seroma/hematoma, dehiscence from surgical procedures	Up to 3 months
Secondary	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
Secondary	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