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RecruitingPhase 4NCT07385313

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

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

Sponsor

Aroa Biosurgery Limited

Enrollment

30 participants

Start Date

Mar 31, 2026

Study Type

INTERVENTIONAL

Conditions

Soft Tissue DefectsSoft Tissue WoundsTraumatic Soft Tissue Defect

Summary

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

Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria16

  • 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

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Interventions

DEVICEMyriad™ applied in conjunction with NPWT

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

DEVICENPWT Alone

Control Arm: NPWT alone ('NPWT')

Locations(2)

University of Colorado-Anschutz Medical Campus

Aurora, Colorado, United States

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

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NCT07385313