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NCT05243966 | RECRUITING | Abdominal Wound Dehiscence

Myriad™ Augmented Soft Tissue Reconstruction Registry
Sponsor:

Aroa Biosurgery Limited

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.

Condition or disease

Abdominal Wound Dehiscence

Necrotizing Soft Tissue Infection

Lower Extremity Wound

Pilonidal Sinus

Anal Fistula

Hidradenitis suppurative

Pressure Injury

Intervention/treatment

Myriad Matrix™ and Myriad Morcells™

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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 800 participants
Official Title : Registry of Myriad™ Utilization in Soft Tissue Reconstruction Procedures
Actual Study Start Date : 2022-01-10
Estimated Primary Completion Date : 2028-01
Estimated Study Completion Date : 2029-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Myriad™ Augmented Soft Tissue Reconstruction Registry

Location Details

NCT05243966

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

Surgery Group LA

Los Angeles, California, United States, 90048

ACTIVE NOT RECRUITING

United States, Florida

Associates in Medicine & Surgery

Fort Myers, Florida, United States, 33919

RECRUITING

United States, Florida

Sacred Heart Assention

Pensacola, Florida, United States, 32504

RECRUITING

United States, Georgia

Northeast Georgia Medical Center, Inc.

Gainesville, Georgia, United States, 30501

RECRUITING

United States, Louisiana

University Medical Center

New Orleans, Louisiana, United States, 70112

ENROLLING BY INVITATION

United States, Louisiana

Ochsner Baptist Medical Center

New Orleans, Louisiana, United States, 70115

RECRUITING

United States, Maryland

Sinai Hospital of Baltimore

Baltimore, Maryland, United States, 21215

ENROLLING BY INVITATION

United States, New York

Nuvance Health Vassar Brothers Medical Center

Poughkeepsie, New York, United States, 12601

ENROLLING BY INVITATION

United States, North Carolina

Moses H Cone Memorial Hospital Operating Corporation

Greensboro, North Carolina, United States, 27401-1004

ENROLLING BY INVITATION

United States, Ohio

Ohio State University Wexner Medical Center

Columbus, Ohio, United States, 43210

ENROLLING BY INVITATION

United States, Pennsylvania

Tower Health Reading Hospital

West Reading, Pennsylvania, United States, 19611