Abdominal Wound DehiscenceMASTRRNCT05243966
Myriad™ Augmented Soft Tissue Reconstruction Registry
An observational study of Abdominal Wound Dehiscence and Necrotizing Soft Tissue Infection, run by Aroa Biosurgery Limited at 15 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Wound Dehiscence, Necrotizing Soft Tissue Infection, Lower Extremity Wound
- What is being tested?
- Myriad Matrix™ and Myriad Morcells™
- Type of treatment
- Medical device
- How many people
- 800 participants
- Where
- 15 sitesUnited States
- Study dates
- 10 Jan 2022to Jan 2029
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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 study
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Brandon Bosque, DMP,CWSP contact
15 sites in 1 country
United States15 sites, 12 recruiting
- Recruiting
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
Research Coordinator, 443-220-1438
Joshua Wolf, MD
- Enrolling by invitation
Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
- Active, not recruiting
Associates in Medicine & Surgery
Fort Myers, Florida, 33919
- Recruiting
Northeast Georgia Medical Center, Inc.
Gainesville, Georgia, 30501
Emily Murdoch, (770)-219-3438, Emily.murdoch@nghs.com
William M Vassy, MD
- Completed
Moses H Cone Memorial Hospital Operating Corporation
Greensboro, North Carolina, 27401-1004
- Enrolling by invitation
University of IOWA Health Care
Iowa City, Iowa, 52242
- Recruiting
Lancaster General Hospital
Lancaster, Pennsylvania, 17601
Medoza Ameen, 223-221-1177, Medoza.ameen@pennmedicine.upenn.edu
Lindsey Perea, DO
- Completed
Surgery Group LA
Los Angeles, California, 90048
- Recruiting
The Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Thomas Carver, MD, 414-955-1751, tcarver@mcw.edu
Jacob Peschman, MD, 414-955-1751
- Recruiting
University Medical Center
New Orleans, Louisiana, 70112
Alison Smith, MD, PhD, 504-903-9009, asmi60@lsuhsc.edu
Frank Lau, MD, 504-412-1240, flau@lsuhsc.edu
- Enrolling by invitation
Ochsner Baptist Medical Center
New Orleans, Louisiana, 70115
- Recruiting
Asencion Sacred Heart
Pensacola, Florida, 32504
Kymberly Palmer, 813-843-1398, Kymberly.palmer@ascension.org
Kyle J. Leneweaver, DO
- Enrolling by invitation
The Diane & Bruce Halle Arizona Burn Center at Valleywise Health
Phoenix, Arizona, 85008
- Enrolling by invitation
Nuvance Health Vassar Brothers Medical Center
Poughkeepsie, New York, 12601
- Enrolling by invitation
Tower Health Reading Hospital
West Reading, Pennsylvania, 19611
About this study
Official title: Registry of Myriad™ Utilization in Soft Tissue Reconstruction Procedures
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.
Read the detailed description
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.
- Conditions
- Abdominal Wound Dehiscence, Necrotizing Soft Tissue Infection, Lower Extremity Wound, Pilonidal Sinus, Anal Fistula, Hidradenitis Suppurativa
- Being tested
- Myriad Matrix™ and Myriad Morcells™
- Keywords
- Soft tissue reconstruction, Limb salvage, Extracellular matrix, Soft tissue reinforcement, Wound reconstruction, Regenerative medicine
- Medical subject headings
- Pilonidal Sinus, Rectal Fistula, Hidradenitis Suppurativa, Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myriad Matrix™ and Myriad Morcells™Device
Ovine forestomach matrix sheet graft and morselized extracellular matrix
| Study group | Role | What they receive |
|---|---|---|
| Myriad™ | Ovine forestomach matrix sheet graft and morselized extracellular matrix Receives: Device: Myriad Matrix™ and Myriad Morcells™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with treatment emergent adverse events during the study
Nature, frequency, and severity of adverse events
Measured: 3 years
Secondary outcomes (4)
Time (weeks) to complete healing
When Myriad™ is used in soft tissue reinforcement the time to would closure will be recorded
Measured: Up to 52 weeks
Percentage of surgical complications
Reporting the incidence of infection, seroma/hematoma, dehiscence from surgical procedures
Measured: 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
Measured: 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
Measured: 1 week post application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start10 Jan 2022
- Primary completionJan 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Abdominal Wound DehiscenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Aroa Biosurgery Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tracee Short, MD, Study chair, Short Consulting Group, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05243966
- Sponsor's protocol ID
- CIP.SUR.001
- Acronym
- MASTRR
- Status last verified
- Jan 2026
- First submitted
- 8 Feb 2022
- Last updated
- 15 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Short T, Lawlor J, Martyka P, Wolf JH, Felton JM, Smith AA, Nasseri YY, Barnajian M, Vassy WM, Cormican M, Kumar P, Choi JJ, Lau L, Loftus JH, Bernal NP, Butts CA, Dillingham CS, Leneweaver KJ, Simon J, Bosque BA, Young DA, May BCH. Safety of Ovine Forestomach Matrix Across 474 Soft Tissue Defects: Interim Results from the Prospective Multicenter MASTRR Registry. Adv Ther. 2026 Sep 3. doi: 10.1007/s12325-026-03768-0. Online ahead of print.
PubMed 42690295Trinh 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.
PubMed 42087918
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry of Myriad™ Utilization in Soft Tissue Reconstruction Procedures
- ClinicalTrials.gov ID
- NCT05243966
- Acronym / sponsor ID
- MASTRR / CIP.SUR.001
- Conditions
- Abdominal Wound Dehiscence, Necrotizing Soft Tissue Infection, Lower Extremity Wound, Pilonidal Sinus, Anal Fistula, Hidradenitis Suppurativa
- Keywords
- Soft tissue reconstruction, Limb salvage, Extracellular matrix, Soft tissue reinforcement, Wound reconstruction, Regenerative medicine
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Aroa Biosurgery LimitedIndustry (pharma, biotech, devices)
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 17 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Myriad™ | – | Device: Myriad Matrix™ and Myriad Morcells™Ovine forestomach matrix sheet graft and morselized extracellular matrix |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Myriad Matrix™ and Myriad Morcells™Ovine forestomach matrix sheet graft and morselized extracellular matrix | Device | Myriad™ |
Primary outcome
Proportion of participants with treatment emergent adverse events during the study
Time frame: 3 years
Nature, frequency, and severity of adverse events
4 secondary outcomes
Time (weeks) to complete healing
Time frame: Up to 52 weeks
Percentage of surgical complications
Time frame: Up to 3 months
Time (weeks) to 100% granulation
Time frame: Up to 3 months
Percentage of split thickness skin graft take at 1 week post Matrix™ application
Time frame: 1 week post application
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Derived from this study: PubMed 42690295Short T, Lawlor J, Martyka P, Wolf JH, Felton JM, Smith AA, Nasseri YY, Barnajian M, Vassy WM, Cormican M, Kumar P, Choi JJ, Lau L, Loftus JH, Bernal NP, Butts CA, Dillingham CS, Leneweaver KJ, Simon J, Bosque BA, Young DA, May BCH. Safety of Ovine Forestomach Matrix Across 474 Soft Tissue Defects: Interim Results from the Prospective Multicenter MASTRR Registry. Adv Ther. 2026 Sep 3. doi: 10.1007/s12325-026-03768-0. Online ahead of print.
- Derived from this study: PubMed 42087918Trinh 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brandon Bosque, DMP,CWSP contact
Tracee Short, MD study chair
Short Consulting Group, LLC
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Wound Dehiscence and Necrotizing Soft Tissue Infection, run by Aroa Biosurgery Limited at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Barnaby May, PhD (+64 21 056 9995, barnaby.may@aroa.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with treatment emergent adverse events during the study (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05243966, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.