Soft Tissue DefectsPhase 4COVERNCT07385313
Combined OFM and Vacuum-assisted Therapy for Expedited Regeneration Over Structures
A Phase 4 study testing Myriad™ applied in conjunction with NPWT and NPWT Alone in people with Soft Tissue Defects and Soft Tissue Wounds, run by Aroa Biosurgery Limited at 2 sites in United States.
Trial summary
Demonstrate faster tissue coverage of exposed structures using OFM in combination with negative pressure wound therapy (NPWT), versus NPWT alone Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Soft Tissue Defects, Soft Tissue Wounds, Traumatic Soft Tissue Defect
- What is being tested?
- Myriad™ applied in conjunction with NPWT and NPWT Alone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Mar 2026to Apr 2027
- Phase
- Phase 4
- 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
Who may be able to join
- Patients will be considered eligible for the study based on the following criteria:
- Willing and able to provide written informed consent and to comply with the requirements of the Clinical Investigational Plan
- Male or female patients aged 18 years or above
- Patient is requiring reconstruction of a full thickness soft tissue defect, that includes exposed structures (bone, tendon, or neurovascular), upper or lower extremity.
- Total defect size, range 25 to 800 cm2
Who cannot join
- Patients will be excluded from the study based on the following criteria:
- Patients with known sensitivity to ovine (sheep) derived material
- Pregnant or lactating females.
- Patients who are prisoners.
- Patients who are likely not to complete the study.
- Patients who, in the opinion of the Investigator, are unlikely to comply with the protocol.
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- Patients currently participating in or have participated in another clinical study within the past 30 days prior to enrolment that at the discretion of the Investigator makes them unsuitable for inclusion in the study.
- Any subject who, at the discretion of the Investigator, is not suitable for inclusion in the study.
- Any medical condition, recent treatment or serious intercurrent illness that, in the opinion of the Investigator, may make it undesirable for the patient to participate in the study.
- Obesity (BMI>45)
- Blood glucose ≥350 mg/dL at admission
- History of chronic peripheral vascular disease
- Current immunosuppression
- Recent neoadjuvant chemotherapy or radiotherapy
- Previous or concurrent application of a cell/tissue-based product (CTP, or skin substitute) at the wound site within 30 days of the Screening Visit
- Defect is a third degree burn
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of Colorado-Anschutz Medical Campus
Aurora, Colorado, 80045
Alyssa Caldwell-McGee, 303-517-2669, alyssa.caldwell-mcgee@cuanschutz.edu
Tracey MacDermott, (303)724-2757, TRACEY.MACDERMOTT@CUANSCHUTZ.EDU
- Recruiting
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Stephanie DeMoor, 210-743-4147, DeMoorS@uthscsa.edu
Rachelle Jonas, 2107434144, babbittr@uthscsa.edu
About this study
Official title: Randomized Prospective Evaluation of Ovine Forestomach Matrix (OFM) and NPWT to Accelerate Tissue Coverage Over Exposed Structures
Demonstrate faster tissue coverage of exposed structures using OFM in combination with negative pressure wound therapy (NPWT), versus NPWT alone
Read the detailed description
Ovine forestomach matrix (OFM) is a decellularized extracellular matrix bioscaffold developed for a range of soft tissue repair, reconstruction, and wound healing applications. OFM is a platform technology used in numerous products, including Myriad™ Matrix, Endoform™ Natural, Endoform™ Antimicrobial, and Ovitex® Reinforced Bioscaffolds. Preclinical and clinical studies have evaluated OFM with respect to mesenchymal stromal cell recruitment, cellular proliferation, angiogenesis, vascularization, and modulation of wound protease activity. Over time, the OFM material is resorbed and incorporated into the patient's soft tissue during the wound healing process.
Myriad devices are composed entirely of OFM and are available in either a sheet ("Matrix") or particulate ("Morcells") configuration. The devices are applied directly to soft tissue defects to support tissue infill and coverage. These devices have been the subject of multiple clinical studies across a spectrum of applications in wound healing, soft tissue repair, and plastic and reconstructive surgery. These studies, together with extensive preclinical testing, provide background information regarding the use of Myriad devices across a range of procedures in the general patient population.
The present study has been designed as a randomized clinical investigation to evaluate outcomes associated with the use of Myriad devices in the treatment of traumatic wounds when used in combination with negative pressure wound therapy (NPWT). Myriad devices are indicated for soft tissue repair and reconstruction and may be used at the discretion of the attending physician. Myriad devices may be used concomitantly with NPWT across a wide range of surgical procedures where soft tissue is missing or damaged.
This randomized clinical investigation design has been selected to generate additional clinical evidence to evaluate time (in days) to achieve complete tissue coverage of exposed structures, wound volume reduction, wound area reduction, and other key clinical parameters in traumatic wound management.
- Being tested
- Myriad™ applied in conjunction with NPWT, NPWT Alone
- Keywords
- Traumatic Wounds, Soft Tissue Repair, Negative Pressure Wound Therapy, Ovine Forestomach Matrix, Wound Healing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myriad™ applied in conjunction with NPWTDevice
Myriad™ applied in conjunction with NPWT ('Myriad+NPWT')
NPWT AloneDevice
Control Arm: NPWT alone ('NPWT')
| Study group | Role | What they receive |
|---|---|---|
| Interventional Arm | Experimental | Myriad™ applied in conjunction with NPWT ('Myriad+NPWT') Receives: Device: Myriad™ applied in conjunction with NPWT |
| Control Arm | Active comparator | NPWT alone ('NPWT') Receives: Device: NPWT Alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tissue Coverage
Time (days) to complete tissue coverage of the exposed structure
Measured: Up to 56 days/ 8 week follow up
Secondary outcomes (4)
Complete coverage of exposed structures
Percent of defects with complete coverage of exposed structures by 4 weeks
Measured: up to 28 days (4 weeks)
Post operative complications
Percent of patients with post operative complications (defined as seroma, hematoma, minor infection (cellulitis), major infection (requiring additional surgical intervention, incision and drainage, debridement, additional usage of/change in antibiotic therapy), or skin necrosis/dehiscence)
Measured: Up to 56 days/ 8 week follow up
NPWT Usage
Length of Negative Pressure Wound Therapy (NPWT) usage (days)
Measured: Up to 56 days/ 8 week follow up
Wound depth infill
Rate of depth infill (mm per week)
Measured: 56 days/up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start31 Mar 2026
- Primary completionMar 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue DefectsStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized into two arms: * Interventional Arm: Myriad™ applied in conjunction with NPWT ('Myriad+NPWT') * Control Arm: NPWT alone ('NPWT')
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aroa Biosurgery Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Coalition for National Trauma Research
- Responsible party
- Sponsor
- Investigators
- Julie Rizzo, MD, Principal investigator, Brooke Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07385313
- Sponsor's protocol ID
- CIP.AROA.005
- Acronym
- COVER
- Status last verified
- Apr 2026
- First submitted
- 27 Jan 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Prospective Evaluation of Ovine Forestomach Matrix (OFM) and NPWT to Accelerate Tissue Coverage Over Exposed Structures
- ClinicalTrials.gov ID
- NCT07385313
- Acronym / sponsor ID
- COVER / CIP.AROA.005
- Keywords
- Traumatic Wounds, Soft Tissue Repair, Negative Pressure Wound Therapy, Ovine Forestomach Matrix, Wound Healing
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Aroa Biosurgery LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Coalition for National Trauma Research
- Study start
- 31 Mar 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 4 Feb 2026 (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.
Demonstrate faster tissue coverage of exposed structures using OFM in combination with negative pressure wound therapy (NPWT), versus NPWT alone
Detailed description
Ovine forestomach matrix (OFM) is a decellularized extracellular matrix bioscaffold developed for a range of soft tissue repair, reconstruction, and wound healing applications. OFM is a platform technology used in numerous products, including Myriad™ Matrix, Endoform™ Natural, Endoform™ Antimicrobial, and Ovitex® Reinforced Bioscaffolds. Preclinical and clinical studies have evaluated OFM with respect to mesenchymal stromal cell recruitment, cellular proliferation, angiogenesis, vascularization, and modulation of wound protease activity. Over time, the OFM material is resorbed and incorporated into the patient's soft tissue during the wound healing process.
Myriad devices are composed entirely of OFM and are available in either a sheet ("Matrix") or particulate ("Morcells") configuration. The devices are applied directly to soft tissue defects to support tissue infill and coverage. These devices have been the subject of multiple clinical studies across a spectrum of applications in wound healing, soft tissue repair, and plastic and reconstructive surgery. These studies, together with extensive preclinical testing, provide background information regarding the use of Myriad devices across a range of procedures in the general patient population.
The present study has been designed as a randomized clinical investigation to evaluate outcomes associated with the use of Myriad devices in the treatment of traumatic wounds when used in combination with negative pressure wound therapy (NPWT). Myriad devices are indicated for soft tissue repair and reconstruction and may be used at the discretion of the attending physician. Myriad devices may be used concomitantly with NPWT across a wide range of surgical procedures where soft tissue is missing or damaged.
This randomized clinical investigation design has been selected to generate additional clinical evidence to evaluate time (in days) to achieve complete tissue coverage of exposed structures, wound volume reduction, wound area reduction, and other key clinical parameters in traumatic wound management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized into two arms: * Interventional Arm: Myriad™ applied in conjunction with NPWT ('Myriad+NPWT') * Control Arm: NPWT alone ('NPWT')
| Arm | Type | Receives |
|---|---|---|
| Interventional Arm | Experimental | Device: Myriad™ applied in conjunction with NPWTMyriad™ applied in conjunction with NPWT ('Myriad+NPWT') |
| Control Arm | Active comparator | Device: NPWT AloneNPWT alone ('NPWT') |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients will be considered eligible for the study based on the following criteria:
Key exclusion criteria (16 listed)
- Patients will be excluded from the study based on the following criteria:
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™ applied in conjunction with NPWTMyriad™ applied in conjunction with NPWT ('Myriad+NPWT') | Device | Interventional Arm |
| NPWT AloneControl Arm: NPWT alone ('NPWT') | Device | Control Arm |
Primary outcome
Tissue Coverage
Time frame: Up to 56 days/ 8 week follow up
Time (days) to complete tissue coverage of the exposed structure
4 secondary outcomes
Complete coverage of exposed structures
Time frame: up to 28 days (4 weeks)
Post operative complications
Time frame: Up to 56 days/ 8 week follow up
NPWT Usage
Time frame: Up to 56 days/ 8 week follow up
Wound depth infill
Time frame: 56 days/up to 8 weeks
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 13 Apr 2026.
- Individual participant dataSharing planned: Yes
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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.
Julie Rizzo, MD principal investigator
Brooke Army Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Myriad™ applied in conjunction with NPWT and NPWT Alone in people with Soft Tissue Defects and Soft Tissue Wounds, run by Aroa Biosurgery Limited at 2 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 5 inclusion and 16 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 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Lizette Villarreal, MA (2107182308, Lizette@NatTrauma.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tissue Coverage (time frame: Up to 56 days/ 8 week follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Apr 2026.