Myriad™ Augmented Soft Tissue Reconstruction Registry

Description

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.

Conditions

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

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Study Overview

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Study Details

Study overview

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.

Registry of Myriad™ Utilization in Soft Tissue Reconstruction Procedures

Myriad™ Augmented Soft Tissue Reconstruction Registry

Condition
Abdominal Wound Dehiscence
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Surgery Group LA, Los Angeles, California, United States, 90048

Fort Myers

Associates in Medicine & Surgery, Fort Myers, Florida, United States, 33919

Gainesville

Northeast Georgia Medical Center, Inc., Gainesville, Georgia, United States, 30501

New Orleans

University Medical Center, New Orleans, Louisiana, United States, 70112

New Orleans

Ochsner Baptist Medical Center, New Orleans, Louisiana, United States, 70115

Baltimore

Sinai Hospital of Baltimore, Baltimore, Maryland, United States, 21215

Poughkeepsie

Nuvance Health Vassar Brothers Medical Center, Poughkeepsie, New York, United States, 12601

Greensboro

Moses H Cone Memorial Hospital Operating Corporation, Greensboro, North Carolina, United States, 27401-1004

Columbus

Ohio State University Wexner Medical Center, Columbus, Ohio, United States, 43210

West Reading

Tower Health Reading Hospital, West Reading, Pennsylvania, United States, 19611

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Aroa Biosurgery Limited,

Tracee Short, MD, STUDY_CHAIR, Short Consulting Group, LLC

Study Record Dates

2029-01