Combined OFM and Vacuum-assisted Therapy for Expedited Regeneration Over Structures (COVER)

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

Study Overview

• Status: Recruiting
• Conditions: Soft Tissue Defects; Soft Tissue Wounds; Traumatic Soft Tissue Defect
• Intervention / Treatment: Device: NPWT Alone; Device: Myriad™ applied in conjunction with NPWT

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Lizette Villarreal, MA; Phone Number: 2107182308; Email: Lizette@NatTrauma.org
• Study Contact Backup: Name: Serina Zorilla, MSN; Phone Number: 7039300041; Email: serina@nattrauma.org

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado-Anschutz Medical Campus
      • Contact: Tracey MacDermott; Phone Number: (303)724-2757; Email: TRACEY.MACDERMOTT@CUANSCHUTZ.EDU
      • Principal Investigator: Michael Cripps, MD
      • Contact: Alyssa Caldwell-McGee; Phone Number: 303-517-2669; Email: alyssa.caldwell-mcgee@cuanschutz.edu
  • Texas
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • The University of Texas Health Science Center at San Antonio
      • Principal Investigator: Susannah Nicholson, MD
      • Contact: Stephanie DeMoor; Phone Number: 210-743-4147; Email: DeMoorS@uthscsa.edu
      • Contact: Rachelle Jonas; Phone Number: 2107434144; Email: babbittr@uthscsa.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional Arm; Myriad™ applied in conjunction with NPWT ('Myriad+NPWT')	Device: Myriad™ applied in conjunction with NPWT; Myriad™ applied in conjunction with NPWT ('Myriad+NPWT')
Active Comparator: Control Arm; NPWT alone ('NPWT')	Device: NPWT Alone; Control Arm: NPWT alone ('NPWT')

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tissue Coverage	Time (days) to complete tissue coverage of the exposed structure	Up to 56 days/ 8 week follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete coverage of exposed structures	Percent of defects with complete coverage of exposed structures by 4 weeks	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)	Up to 56 days/ 8 week follow up
NPWT Usage	Length of Negative Pressure Wound Therapy (NPWT) usage (days)	Up to 56 days/ 8 week follow up
Wound depth infill	Rate of depth infill (mm per week)	56 days/up to 8 weeks

Collaborators and Investigators

• Sponsor: Aroa Biosurgery Limited
• Collaborators: Coalition for National Trauma Research
• Investigators: Principal Investigator: Julie Rizzo, MD, Brooke Army Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: January 27, 2026
• First Submitted That Met QC Criteria: January 27, 2026
• First Posted (Actual): February 4, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Wound Healing; Negative Pressure Wound Therapy; Traumatic Wounds; Soft Tissue Repair; Ovine Forestomach Matrix
• Additional Relevant MeSH Terms: Therapeutics; Surgical Procedures, Operative; Drainage; Wound Closure Techniques; Negative-Pressure Wound Therapy
• Other Study ID Numbers: CIP.AROA.005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: Data will become available one year after initial results publication.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No