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This is an observational study designed to evaluate the safety and clinical outcomes of Myriadâ„¢ in soft tissue reconstruction procedures. The study will enroll participants who are undergoing a surgical procedure, where the attending physician will use Myriadâ„¢ as part of the surgical intervention.
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 a registry study and will enroll participants who are undergoing a surgical procedure, and where the attending physician will use Myriad Matrixâ„¢ and/or Morcellsâ„¢ as part of the surgical intervention.
Participants enrolled in the study will be undergoing a range of surgical procedures involving the reconstruction of soft tissues, including but not limited to:
Other procedure types may be included at the discretion of the Investigator/Research Team.
Participants that are being enrolled in the study would otherwise be undergoing their surgical procedure with either of the Myriadâ„¢ devices as part of Standard of Care (SoC).
The pre-operative care and preparation of the surgical site (prior to the application of Myriadâ„¢ devices) shall be undertaken at the discretion of the attending physician and per their institutional protocols and procedures. Surgical technique for the participants reconstruction is at the discretion of the attending physician. Use of Myriad Matrixâ„¢ or Morcells as part of the surgery shall be per the products Instructions for Use. Myriad Matrixâ„¢ devices may be implanted or used for dermal regeneration as part of the participants surgical procedure. Myriad Morcellsâ„¢ may be used for dermal regeneration and in combination with the Myriad Matrixâ„¢ devices. The participants post-operative care is at the discretion of the attending physician.
Early and late-stage healing outcomes will be assessed as part of the study and as part of standard of care.
Through the course of treatment and following up care de-identified patient data (quantitative qualitative assessment measures and digital images) will be captured and from the basis of the registry dataset.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Myriadâ„¢ | Ovine forestomach matrix sheet graft and morselized extracellular matrix |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Myriad Matrixâ„¢ and Myriad Morcellsâ„¢ | Device | Ovine forestomach matrix sheet graft and morselized extracellular matrix |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with treatment emergent adverse events during the study | Nature, frequency, and severity of adverse events | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Time (weeks) to complete healing | When Myriadâ„¢ is used in soft tissue reinforcement the time to would closure will be recorded | Up to 52 weeks |
| Percentage of surgical complications | Reporting the incidence of infection, seroma/hematoma, dehiscence from surgical procedures |
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Inclusion Criteria:
Exclusion Criteria:
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The study is being carried out at approximately 10 sites in the U.S. Across all sites, about 300 individuals will participate in the study where the Investigator is planning to utilize Myriadâ„¢ as a part of their surgical procedure.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Barnaby May, PhD | Contact | +64 21 056 9995 | barnaby.may@aroa.com | |
| Brandon Bosque, DMP,CWSP | Contact | Brandon.Bosque@aroa.com |
| Name | Affiliation | Role |
|---|---|---|
| Tracee Short, MD | Short Consulting Group, LLC | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Surgery Group LA | Completed | Los Angeles | California | 90048 | United States | |
| Associates in Medicine & Surgery |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42087918 | Derived | Trinh 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. |
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| Up to 3 months |
| Time (weeks) to 100% granulation | Where applicable, when Myriadâ„¢ is used for dermal regeneration, the time until full graft integration will be recorded | Up to 3 months |
| Percentage of split thickness skin graft take at 1 week post Matrixâ„¢ application | Where applicable, when Myriadâ„¢ is used for dermal regeneration and a split thickness skin graft is used the percentage of graft take at 1 week will be recorded | 1 week post application |
| Active, not recruiting |
| Fort Myers |
| Florida |
| 33919 |
| United States |
| Asencion Sacred Heart | Recruiting | Pensacola | Florida | 32504 | United States |
|
| Northeast Georgia Medical Center, Inc. | Recruiting | Gainesville | Georgia | 30501 | United States |
|
| University Medical Center | Recruiting | New Orleans | Louisiana | 70112 | United States |
|
| Ochsner Baptist Medical Center | Enrolling by invitation | New Orleans | Louisiana | 70115 | United States |
| Sinai Hospital of Baltimore | Recruiting | Baltimore | Maryland | 21215 | United States |
|
| Nuvance Health Vassar Brothers Medical Center | Enrolling by invitation | Poughkeepsie | New York | 12601 | United States |
| Moses H Cone Memorial Hospital Operating Corporation | Enrolling by invitation | Greensboro | North Carolina | 27401-1004 | United States |
| Ohio State University Wexner Medical Center | Enrolling by invitation | Columbus | Ohio | 43210 | United States |
| Lancaster General Hospital | Recruiting | Lancaster | Pennsylvania | 17601 | United States |
|
| Tower Health Reading Hospital | Enrolling by invitation | West Reading | Pennsylvania | 19611 | United States |
| The Medical College of Wisconsin | Recruiting | Milwaukee | Wisconsin | 53226 | United States |
|
| ID | Term |
|---|---|
| D010864 | Pilonidal Sinus |
| D012003 | Rectal Fistula |
| D017497 | Hidradenitis Suppurativa |
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D003560 | Cysts |
| D009369 | Neoplasms |
| D007412 | Intestinal Fistula |
| D016154 | Digestive System Fistula |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D012002 | Rectal Diseases |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017192 | Skin Diseases, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D016575 | Hidradenitis |
| D013543 | Sweat Gland Diseases |
| D012883 | Skin Ulcer |
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