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.
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 Matrix™ and/or Morcells™ 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: * Abdominal dehiscence * Necrotizing soft tissue infection (NSTI) * Lower extremity complex non-healing wounds (limb salvage) * Pilonidal sinus disease * Anal fistula * Hidradenitis suppurativa reconstruction * Pressure injury reconstruction 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 Myriad™ devices as part of Standard of Care (SoC). The pre-operative care and preparation of the surgical site (prior to the application of Myriad™ 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 Matrix™ or Morcells as part of the surgery shall be per the products Instructions for Use. Myriad Matrix™ devices may be implanted or used for dermal regeneration as part of the participants surgical procedure. Myriad Morcells™ may be used for dermal regeneration and in combination with the Myriad Matrix™ 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.
Study Type
OBSERVATIONAL
Enrollment
800
Ovine forestomach matrix sheet graft and morselized extracellular matrix
Surgery Group LA
Los Angeles, California, United States
COMPLETEDAssociates in Medicine & Surgery
Fort Myers, Florida, United States
ACTIVE_NOT_RECRUITINGAsencion Sacred Heart
Pensacola, Florida, United States
RECRUITINGNortheast Georgia Medical Center, Inc.
Gainesville, Georgia, United States
RECRUITINGUniversity Medical Center
New Orleans, Louisiana, United States
RECRUITINGOchsner Baptist Medical Center
New Orleans, Louisiana, United States
ENROLLING_BY_INVITATIONSinai Hospital of Baltimore
Baltimore, Maryland, United States
RECRUITINGNuvance Health Vassar Brothers Medical Center
Poughkeepsie, New York, United States
ENROLLING_BY_INVITATIONMoses H Cone Memorial Hospital Operating Corporation
Greensboro, North Carolina, United States
ENROLLING_BY_INVITATIONOhio State University Wexner Medical Center
Columbus, Ohio, United States
ENROLLING_BY_INVITATION...and 2 more locations
Proportion of participants with treatment emergent adverse events during the study
Nature, frequency, and severity of adverse events
Time frame: 3 years
Time (weeks) to complete healing
When Myriad™ is used in soft tissue reinforcement the time to would closure will be recorded
Time frame: Up to 52 weeks
Percentage of surgical complications
Reporting the incidence of infection, seroma/hematoma, dehiscence from surgical procedures
Time frame: Up to 3 months
Time (weeks) to 100% granulation
Where applicable, when Myriad™ is used for dermal regeneration, the time until full graft integration will be recorded
Time frame: Up to 3 months
Percentage of split thickness skin graft take at 1 week post Matrix™ application
Where applicable, when Myriad™ is used for dermal regeneration and a split thickness skin graft is used the percentage of graft take at 1 week will be recorded
Time frame: 1 week post application
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