Myriad™ Augmented Soft Tissue Reconstruction Registry (MASTRR)

Aroa Biosurgery

Status

Enrolling

Conditions

Abdominal Wound Dehiscence

Pressure Injury

Anal Fistula

Hidradenitis Suppurativa

Pilonidal Sinus

Lower Extremity Wound

Necrotizing Soft Tissue Infection

Treatments

Device: Myriad Matrix™ and Myriad Morcells™

Study type

Observational

Funder types

Industry

Identifiers

NCT05243966

CIP.SUR.001

Details and patient eligibility

About

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.

Full 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.

Enrollment

800 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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