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

NCT07385313 | Recruiting Phase 4 FDA Device

• 1 other identifier: CIP.AROA.005
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

Demonstrate faster tissue coverage of exposed structures using OFM in combination with negative pressure wound therapy (NPWT), versus NPWT alone

Conditions

Soft Tissue Wounds; Traumatic Soft Tissue Defect; Soft Tissue Defects

Keywords

Traumatic Wounds; Soft Tissue Repair; Negative Pressure Wound Therapy; Ovine Forestomach Matrix; Wound Healing

Outcome Measures

Primary Outcomes (1)

• Tissue Coverage

  Time (days) to complete tissue coverage of the exposed structure

  Up to 56 days/ 8 week follow up

Secondary Outcomes (4)

• Complete coverage of exposed structures

  up to 28 days (4 weeks)

• Post operative complications

  Up to 56 days/ 8 week follow up

• NPWT Usage

  Up to 56 days/ 8 week follow up

• Wound depth infill

  56 days/up to 8 weeks

Study Arms (2)

Interventional Arm

EXPERIMENTAL

Myriad™ applied in conjunction with NPWT ('Myriad+NPWT')

Device: Myriad™ applied in conjunction with NPWT

Control Arm

ACTIVE COMPARATOR

NPWT alone ('NPWT')

Device: NPWT Alone

Interventions

Myriad™ applied in conjunction with NPWT DEVICE

Myriad™ applied in conjunction with NPWT ('Myriad+NPWT')

Interventional Arm

NPWT Alone DEVICE

Control Arm: NPWT alone ('NPWT')

Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Aroa Biosurgery Limited: lead
• Coalition for National Trauma Research: collaborator

Study Sites (2)

University of Colorado-Anschutz Medical Campus

Aurora, Colorado, 80045, United States

RECRUITING

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

MeSH Terms

Interventions

Negative-Pressure Wound Therapy

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Surgical Procedures, Operative; Wound Closure Techniques

Study Officials

• Julie Rizzo, MD

  Brooke Army Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lizette Villarreal, MA

CONTACT

2107182308; Lizette@NatTrauma.org

Serina Zorilla, MSN

CONTACT

7039300041; serina@nattrauma.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Investigators cannot be blinded to the treatment groups
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be randomized into two arms: * Interventional Arm: Myriad™ applied in conjunction with NPWT ('Myriad+NPWT') * Control Arm: NPWT alone ('NPWT')

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: February 4, 2026
• Study Start: March 31, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will become available one year after initial results publication.

Locations

US (2)