Clinical trial NCT05243966: Myriad™ Augmented Soft Tissue Reconstruction Registry
Official title: Registry of Myriad™ Utilization in Soft Tissue Reconstruction Procedures
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Abdominal Wound Dehiscence
Necrotizing Soft Tissue Infection
Lower Extremity Wound
Pilonidal Sinus
Anal Fistula
Hidradenitis Suppurativa
Pressure Injury
Keywords: Soft tissue reconstruction
Limb salvage
Extracellular matrix
Soft tissue reinforcement
Wound reconstruction
Regenerative medicine
Lead sponsor: Aroa Biosurgery Limited
Sponsor class: INDUSTRY
First posted: 2022-02-17
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study is being carried out at approximately 10 sites in the U.S. Across all sites, about 300 individuals will participate in the study where the Investigator is planning to utilize Myriad™ as a part of their surgical procedure.

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of participants with treatment emergent adverse events during the study
timeFrame: 3 years
Secondary outcomes:
measure: Time (weeks) to complete healing
timeFrame: Up to 52 weeks
measure: Percentage of surgical complications
timeFrame: Up to 3 months
measure: Time (weeks) to 100% granulation
timeFrame: Up to 3 months
measure: Percentage of split thickness skin graft take at 1 week post Matrix™ application
timeFrame: 1 week post application
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Surgery Group LA
state: California
city: Fort Myers
country: United States
facility: Associates in Medicine & Surgery
state: Florida
city: Pensacola
country: United States
facility: Asencion Sacred Heart
state: Florida
city: Gainesville
country: United States
facility: Northeast Georgia Medical Center, Inc.
state: Georgia
city: New Orleans
country: United States
facility: University Medical Center
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Baptist Medical Center
state: Louisiana
city: Baltimore
country: United States
facility: Sinai Hospital of Baltimore
state: Maryland
city: Poughkeepsie
country: United States
facility: Nuvance Health Vassar Brothers Medical Center
state: New York
city: Greensboro
country: United States
facility: Moses H Cone Memorial Hospital Operating Corporation
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University Wexner Medical Center
state: Ohio
city: West Reading
country: United States
facility: Tower Health Reading Hospital
state: Pennsylvania
Study officials:
affiliation: Short Consulting Group, LLC
name: Tracee Short, MD
role: STUDY_CHAIR
References: