RECRUITING

Myriad™ Augmented Soft Tissue Reconstruction Registry

Talk to us

Conditions

Abdominal Wound DehiscenceNecrotizing Soft Tissue InfectionLower Extremity WoundPilonidal SinusAnal FistulaHidradenitis SuppurativaPressure InjurySoft tissue reconstructionLimb salvageExtracellular matrixSoft tissue reinforcementWound reconstructionRegenerative medicine

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Registry of Myriad™ Utilization in Soft Tissue Reconstruction Procedures

Quick Facts

Study Start:2022-01-10
Study Completion:2029-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05243966

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Willing and able to provide written informed consent and to comply with the requirements of Clinical Investigational Plan
  2. * Male or female patients aged 18 years or above
  3. * Patients where Matrix and/or Morcells were used as part of their soft tissue reconstruction procedure
  4. * Subject that are willing and able to comply with all aspects of the treatment and evaluation schedule
  1. * Patients with known sensitivity to ovine (sheep) derived material
  2. * Patients with full thickness ('third degree') burns
  3. * Patients with wounds with uncontrolled clinical infection (CDC Contamination Grade=4)
  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
  5. * Patient is currently participating or has participated in another clinical study within past 30 days prior to enrollment
  6. * Pregnant or lactating women
  7. * Any subject who, at the discretion of the Investigator, is not suitable for inclusion in the study

Contacts and Locations

Study Contact

Barnaby May, PhD
CONTACT
+64 21 056 9995
barnaby.may@aroabio.com
Brandon Bosque, DMP,CWSP
CONTACT
Brandon.Bosque@aroabio.com

Principal Investigator

Tracee Short, MD
STUDY_CHAIR
Short Consulting Group, LLC

Study Locations (Sites)

Surgery Group LA
Los Angeles, California, 90048
United States
Associates in Medicine & Surgery
Fort Myers, Florida, 33919
United States
Northeast Georgia Medical Center, Inc.
Gainesville, Georgia, 30501
United States
University Medical Center
New Orleans, Louisiana, 70112
United States
Ochsner Baptist Medical Center
New Orleans, Louisiana, 70115
United States
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
United States
Nuvance Health Vassar Brothers Medical Center
Poughkeepsie, New York, 12601
United States
Moses H Cone Memorial Hospital Operating Corporation
Greensboro, North Carolina, 27401-1004
United States
Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
United States
Tower Health Reading Hospital
West Reading, Pennsylvania, 19611
United States

Collaborators and Investigators

Sponsor: Aroa Biosurgery Limited

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-01-10
Study Completion Date2029-01

Study Record Updates

Study Start Date2022-01-10
Study Completion Date2029-01

Terms related to this study

Keywords Provided by Researchers

  • Soft tissue reconstruction
  • Limb salvage
  • Extracellular matrix
  • Soft tissue reinforcement
  • Wound reconstruction
  • Regenerative medicine

Additional Relevant MeSH Terms

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