Surgical management of stage 3 and 4 pressure injuries in trauma patients using ovine forestomach matrix grafts: a prospective case series.
Sophia M Trinh, Kaitlyn Andre, Ada I Özcan...
https://pubmed.ncbi.nlm.nih.gov/42087918Actively Recruiting
Age: 18Years +
All Genders
ID05243966
Registry of Myriad™ Utilization in Soft Tissue Reconstruction Procedures
Led by Aroa Biosurgery Limited · Updated on 2026-02-19
800
Participants Needed
13
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are observing the safety and clinical outcomes of Myriad™ devices, specifically Myriad Matrix™ and Myriad Morcells™, used in soft tissue reconstruction surgeries. This Phase IV, multi-center registry study includes participants undergoing various surgical procedures such as abdominal wound dehiscence, necrotizing soft tissue infections, complex lower extremity wounds, pilonidal sinus, anal fistula, hidradenitis suppurativa reconstruction, and pressure injury reconstruction. The study collects data during standard surgical care where these devices are applied. The study involves participants receiving surgical treatment using the Myriad Matrix™ sheet graft and morselized extracellular matrix, either alone or in combination, as part of their soft tissue reconstruction. The surgical approach, including pre-operative care and post-operative management, follows the attending physician's discretion and institutional protocols. The Myriad devices are used according to their instructions for use, and the study captures outcomes related to early and late-stage healing. Participants will be monitored through their regular surgical care with data collected on treatment safety and effectiveness, including adverse events, healing time, complication rates, tissue granulation, and skin graft success. De-identified quantitative and qualitative data, including digital images, will be gathered throughout treatment and follow-up to build the registry dataset. The primary outcome focuses on the proportion of participants experiencing treatment-emergent adverse events over three years.
CONDITIONS
Brief Title
Myriad™ Augmented Soft Tissue Reconstruction Registry
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Willing and able to provide written informed consent and comply with study requirements
- Male or female patients aged 18 years or older
- Patients receiving Matrix and/or Morcells as part of their soft tissue reconstruction surgery
- Willing and able to comply with all treatment and evaluation schedules
You will not qualify if you...
- Known sensitivity to ovine (sheep) derived material
- Full thickness ('third degree') burns
- Wounds with uncontrolled clinical infection (CDC Contamination Grade=4)
- Any serious medical condition or illness making participation undesirable as per investigator
- Participation in another clinical study within 30 days prior to enrollment
- Pregnant or lactating women
- Any subject deemed unsuitable for study inclusion by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Participants provide written informed consent and undergo eligibility assessment.
Surgery and Immediate Post-operative Care
Duration - Day of surgery and immediate recovery period
Participants undergo soft tissue reconstruction surgery using Myriad Matrix™ and/or Morcells™ as part of their surgical procedure. Post-operative care is provided according to the attending physician's discretion and institutional protocols.
1 surgical visit (in-person) and immediate post-operative care visits as per standard of care
Post-operative Follow-up
Duration - Up to 52 weeks
Participants are followed up to assess early and late-stage healing, surgical complications, and treatment outcomes, including wound healing and graft take.
Multiple follow-up visits over up to 1 year as part of standard of care
Trial Site Locations
Total: 13 locations
1
Surgery Group LA
Los Angeles, California, United States, 90048
Completed
2
Associates in Medicine & Surgery
Fort Myers, Florida, United States, 33919
Active, Not Recruiting
3
Asencion Sacred Heart
Pensacola, Florida, United States, 32504
Actively Recruiting
4
Northeast Georgia Medical Center, Inc.
Gainesville, Georgia, United States, 30501
Actively Recruiting
5
University Medical Center
New Orleans, Louisiana, United States, 70112
Actively Recruiting
6
Ochsner Baptist Medical Center
New Orleans, Louisiana, United States, 70115
Enrolling by Invitation
7
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
Actively Recruiting
8
Nuvance Health Vassar Brothers Medical Center
Poughkeepsie, New York, United States, 12601
Enrolling by Invitation
9
Moses H Cone Memorial Hospital Operating Corporation
Greensboro, North Carolina, United States, 27401-1004
Enrolling by Invitation
10
Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
Enrolling by Invitation
11
Lancaster General Hospital
Lancaster, Pennsylvania, United States, 17601
Actively Recruiting
12
Tower Health Reading Hospital
West Reading, Pennsylvania, United States, 19611
Enrolling by Invitation
13
The Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
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Research Team
B
Barnaby May, PhD
B
Brandon Bosque, DMP,CWSP
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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