Ovine forestomach matrix plus vacuum-assisted therapy to speed regeneration over exposed bone, tendon, or nerves

Randomized Prospective Evaluation of Ovine Forestomach Matrix (OFM) and NPWT to Accelerate Tissue Coverage Over Exposed Structures

This test will see if adding an ovine forestomach matrix graft to negative pressure wound therapy helps adults with large traumatic soft tissue defects that expose bone, tendon, or nerves heal faster than negative pressure therapy alone.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Aroa Biosurgery Limited (industry)
• Drugs / interventions: chemotherapy
• Locations: 2 sites (Aurora, Colorado and 1 other locations)
• Trial ID: NCT07385313 on ClinicalTrials.gov

What this trial studies

This randomized phase 4 trial enrolls adults with full-thickness soft tissue defects (25–800 cm2) of the upper or lower extremity that expose bone, tendon, or neurovascular structures and compares standard negative pressure wound therapy (NPWT) alone versus NPWT combined with Myriad devices composed of decellularized ovine forestomach matrix (OFM). The Myriad devices, available as sheets (Matrix) or particulates (Morcells), are applied to the wound bed to support cellular infiltration, angiogenesis, and incorporation into host tissue while NPWT continues. The primary outcome focuses on time to tissue coverage of exposed structures and related wound-healing measures, with standardized wound care and follow-up at participating academic centers. The trial builds on preclinical and clinical data supporting OFM in soft tissue repair and aims to provide comparative evidence for traumatic wound management.

Who should consider this trial

Good fit: Adults aged 18 and older with full-thickness traumatic soft tissue defects of the upper or lower extremity measuring 25–800 cm2 with exposed bone, tendon, or neurovascular structures who can provide informed consent are the intended participants.

Not a fit: Patients with known sensitivity to sheep-derived materials, pregnant or lactating individuals, prisoners, those unlikely to complete follow-up, or patients with defects outside the 25–800 cm2 range are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the combination could shorten time to cover exposed structures and reduce the need for more complex reconstruction or prolonged wound care.

How similar studies have performed: Multiple preclinical studies and clinical reports support OFM’s roles in cell recruitment, angiogenesis, and wound remodeling, but randomized data specifically combining OFM with NPWT for traumatic wounds are limited.

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.
  * 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

Where this trial is running

Aurora, Colorado and 1 other locations

• University of Colorado-Anschutz Medical Campus — Aurora, Colorado, United States (RECRUITING)
• The University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States (RECRUITING)

Study contacts

• Principal investigator: Julie Rizzo, MD — Brooke Army Medical Center
• Study coordinator: Lizette Villarreal, MA

Conditions: Soft Tissue Defects, Soft Tissue Wounds, Traumatic Soft Tissue Defect, Traumatic Wounds, Soft Tissue Repair, Negative Pressure Wound Therapy, Ovine Forestomach Matrix, Wound Healing