About this trial
This study looks at how safe and effective Myriad™ is during soft tissue reconstruction surgeries. It will include patients undergoing various surgical procedures where Myriad™ devices are used. Conditions being treated may include wounds, infections, and other soft tissue issues.
The trial ID is NCT05243966. This is a Phase IV study, which means it is looking at the safety and effectiveness of Myriad™ after its approval. The study plans to include about 800 participants and is FDA-regulated for devices.
Who can join
This study is open to men and women aged 18 and older. Participants must be able to give consent and agree to follow study guidelines. Some patients cannot join, such as those with certain allergies or serious infections. The trial team will confirm eligibility for each person.
Conditions
Abdominal Wound Dehiscence, Necrotizing Soft Tissue Infection, Lower Extremity Wound, Pilonidal Sinus, Anal Fistula, Hidradenitis Suppurativa, Pressure Injury
Age group
Adult, Older adult
The study team makes the final call on eligibility.
What happens in the study
Participants will receive Myriad Matrix™ or Myriad Morcells™ during their surgery. Everyone in the study will receive these devices as part of their routine care. The study will follow participants for three years to track any side effects and healing outcomes.
Where
This trial is running at 13 locations in the United States. 6 of them are currently recruiting.
Asencion Sacred Heart
Pensacola, Florida
Lancaster General Hospital
Lancaster, Pennsylvania
Northeast Georgia Medical Center, Inc.
Gainesville, Georgia
Sinai Hospital of Baltimore
Baltimore, Maryland
The Medical College of Wisconsin
Milwaukee, Wisconsin
University Medical Center
New Orleans, Louisiana
Associates in Medicine & Surgery
Fort Myers, Florida
Moses H Cone Memorial Hospital Operating Corporation
Greensboro, North Carolina
The first 8 of 13 sites are listed here. The registry record has the full list.