Myriad™ Augmented Soft Tissue Reconstruction Registry (MASTRR)

  • STATUS
    Recruiting
  • End date
    Jan 29, 2026
  • participants needed
    300
  • sponsor
    Aroa Biosurgery Limited
Updated on 29 May 2022

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.

Details
Condition Abdominal Wound Dehiscence, Necrotizing Soft Tissue Infection, Lower Extremity Wound, Pilonidal Sinus, Anal Fistula, Hidradenitis Suppurativa, Pressure Injury
Treatment Myriad Matrix™ and Myriad Morcells™
Clinical Study IdentifierNCT05243966
SponsorAroa Biosurgery Limited
Last Modified on29 May 2022

Eligibility

Yes No Not Sure

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
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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