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

Official title

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

Overview

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.

Interventions

• Device Myriad™ applied in conjunction with NPWT
  Myriad™ applied in conjunction with NPWT ('Myriad+NPWT')
• Device NPWT Alone
  Control Arm: NPWT alone ('NPWT')

Primary outcome measures

• Tissue Coverage [Time frame: Up to 56 days/ 8 week follow up]

Secondary outcome measures (4)

• 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 2 centers

• University of Colorado-Anschutz Medical Campus — Aurora
• The University of Texas Health Science Center at San Antonio — San Antonio

Identifiers

NCT: NCT07385313 · CIP.AROA.005

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗