Infections

All Conditions

Wounds and Injuries

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Neoplasms

Digestive System Diseases

Crush Injuries

Communicable Diseases

Fistula

Hidradenitis Suppurativa

Hidradenitis

Pilonidal Sinus

Soft Tissue Infections

Rectal Fistula

Pressure Ulcer

Ulcer

Pathological Conditions, Anatomical

Sweat Gland Diseases

Skin Diseases

Skin Diseases, Bacterial

Bacterial Infections

Mycoses

Bacterial Infections and Mycoses

Skin Diseases, Infectious

Suppuration

Intestinal Fistula

Digestive System Fistula

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Skin Ulcer

Cysts

Ovine forestomach matrix sheet graft and morselized extracellular matrix

Myriad Matrix™ and Myriad Morcells™

Barnaby May, PhD

Brandon Bosque, DMP,CWSP

Yosef Nasseri, MD, FACS, FACRS

Moshe Barnajian, MD, FACRS

Patrick Martyka, DPM

Alison Smith, MD, PhD

Frank Lau, MD

Research Coordinator

Joshua Wolf, MD

Tracee Short, MD

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.

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.

Myriad™ Augmented Soft Tissue Reconstruction Registry

Registry of Myriad™ Utilization in Soft Tissue Reconstruction Procedures

Nature, frequency, and severity of adverse events

When Myriad™ is used in soft tissue reinforcement the time to would closure will be recorded

Reporting the incidence of infection, seroma/hematoma, dehiscence from surgical procedures

Where applicable, when Myriad™ is used for dermal regeneration, the time until full graft integration will be recorded

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

Aroa Biosurgery Limited

Spots Global Cancer Trial Database for necrotizing soft tissue infection