An observational study in Abdominal Wound Dehiscence, Necrotizing Soft Tissue Infection and Lower Extremity Wound, sponsored by Aroa Biosurgery Limited. Recruiting at 15 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-15.
Sponsored by Aroa Biosurgery Limited · Observational
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:
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.
109 studies on the registry are indexed under Pilonidal Sinus; 32 are open to participants now.
This study's planned enrollment of 800 is above the median of 145 across 37 observational studies indexed under Pilonidal Sinus.
Browse Pilonidal Sinus studies →Aroa Biosurgery Limited is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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 Myriad™ as a part of their surgical procedure.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ovine forestomach matrix sheet graft and morselized extracellular matrix
Device: Myriad Matrix™ and Myriad Morcells™
Ovine forestomach matrix sheet graft and morselized extracellular matrix
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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Plan to share: Undecided
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Aroa Biosurgery Limited