Clinical trial · Observational
Myriad™ Augmented Soft Tissue Reconstruction Registry
Registry of Myriad™ Utilization in Soft Tissue Reconstruction Procedures
NCT05243966CI-TRIAL-00118011MASTRRrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Abdominal Wound Dehiscence | — | UNRESOLVED | — |
| Anal Fistula | — | UNRESOLVED | — |
| Hidradenitis Suppurativa | — | UNRESOLVED | — |
| Lower Extremity Wound | — | UNRESOLVED | — |
| Necrotizing Soft Tissue Infection | — | UNRESOLVED | — |
| Pilonidal Sinus | — | UNRESOLVED | — |
| Pressure Injury | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Myriad Matrix™ and Myriad Morcells™ | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Myriad™
- description
- Ovine forestomach matrix sheet graft and morselized extracellular matrix
- interventionNames
- Device: Myriad Matrix™ and Myriad Morcells™
Primary outcomes (1)
- measure
- Proportion of participants with treatment emergent adverse events during the study
- timeFrame
- 3 years
- description
- Nature, frequency, and severity of adverse events
Secondary outcomes (4)
- measure
- Time (weeks) to complete healing
- timeFrame
- Up to 52 weeks
- description
- When Myriad™ is used in soft tissue reinforcement the time to would closure will be recorded
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion 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
Exclusion Criteria:
* 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 studyReferences
Publications (1)
- DERIVEDTrinh SM, Andre K, Ozcan AI, Vitharana DS, Deville PE, Mason JW, Hunt JP, Marr AB, Greiffenstein PP, Stuke LE, Smith AA. Surgical management of stage 3 and 4 pressure injuries in trauma patients using ovine forestomach matrix grafts: a prospective case series. Front Surg. 2026 Apr 20;13:1704665. doi: 10.3389/fsurg.2026.1704665. eCollection 2026. PMID 42087918