Status:
RECRUITING
Myriad™ Augmented Soft Tissue Reconstruction Registry
Lead Sponsor:
Aroa Biosurgery Limited
Conditions:
Abdominal Wound Dehiscence
Necrotizing Soft Tissue Infection
Eligibility:
All Genders
18+ years
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 surgic...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 10 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2029
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT05243966
Start Date
January 10 2022
End Date
January 1 2029
Last Update
March 7 2025
Active Locations (11)
Enter a location and click search to find clinical trials sorted by distance.
1
Surgery Group LA
Los Angeles, California, United States, 90048
2
Associates in Medicine & Surgery
Fort Myers, Florida, United States, 33919
3
Asencion Sacred Heart
Pensacola, Florida, United States, 32504
4
Northeast Georgia Medical Center, Inc.
Gainesville, Georgia, United States, 30501