NCT05243966

Myriad™ Augmented Soft Tissue Reconstruction Registry

Registry of Myriad™ Utilization in Soft Tissue Reconstruction Procedures

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 800 (estimated)
• Sponsor: Aroa Biosurgery Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Myriad Matrix™ and Myriad Morcells™	Ovine forestomach matrix sheet graft and morselized extracellular matrix

Timeline

• Start date: 2022-01-10
• Primary completion: 2028-01-01
• Completion: 2029-01-01
• First posted: 2022-02-17
• Last updated: 2026-02-19

Locations

13 sites across 1 country: United States

Regulatory

• FDA-regulated device study