Miro3D Randomized Controlled Trial (RCT)

Acellular tissue scaffolds, such as Miro3D, were developed to aid in the management of complex tissue defect wounds and ulcerations by providing a structural matrix that supports cellular infiltration and tissue regeneration. However, high-quality prospective data remain limited, particularly regarding soft tissue deficits and pressure ulcerations. This prospective RCT is designed to evaluate the efficacy and outcomes of subjects randomized to receive either SOC alone or SOC with the addition of tissue scaffolding techniques (Miro3D) over a twelve (12)-week timeframe.

The trial will investigate two categories of complex wounds: soft tissue wounds, including post-fasciotomy wounds and wounds resulting from necrotizing skin and soft tissue infection (NSSTI), and chronic pressure ulcerations, with a focus on decubitus and ischial pressure ulcers. The trial aims to generate real-world data, including cost-effectiveness parameters, and features a crossover arm to evaluate the impact of delayed wound bed preparation and the application of tissue scaffolds.

Additionally, the trial will evaluate healing quality using digital wound photography and mathematical analysis of wound redness as a surrogate marker for granulation tissue formation. Time to hospital discharge will also be tracked for acute wounds to assess cost and resource utilization. By analyzing the effectiveness of Miro3D in combination with SOC, this trial seeks to provide meaningful insights into optimizing wound management strategies.

Inclusion criteria

• Subjects must fulfill all the following inclusion criteria to qualify for enrollment:

• Men or women 18-90 years of age at enrollment.
• Ability to sign consent by subject or LAR.
• Wounds in one of the two arms:

• A. Soft tissue wounds with a minimum size of 1 cm x 1 cm surface area and a maximum size of 40 cm L x 20 cm W x 5 cm D, resulting from either post-fasciotomy or post-NSSTI, including the pelvis with the lower extremity. Fasciotomies must have undergone complete debridement and, in the opinion of a trial investigator, be appropriate for wound healing but not ready for primary closure at randomization.
• B. Chronic, complex pressure ulcers classified as Stage III or higher, located in the decubitus or ischial region, that have not achieved at least a 50% reduction in ulcer area despite receiving documented SOC treatment for a minimum of four (4) weeks, with confirmed patient compliance.
• Subjects must agree to proper offloading and/or compression of the wound or ulcer throughout the trial.
• Written informed consent is required for digital photo imaging.
• For the Miro3D plus SOC arm, the wound or ulcer must have a clean base that is free of devitalized tissue or debris at the time of Miro3D placement.
• Subjects receiving NPWT at baseline are eligible for enrollment. The use of NPWT during the trial will be at the discretion of the treating provider.

Exclusion criteria

• Subjects who meet any of the following criteria will be excluded from trial participation:

• The PAR of the pressure ulcer arm has reduced by 50% or more after four (4) weeks of SOC.
• Wounds with active invasive infection not yet controlled in the opinion of a trial investigator.
• Wounds with vascular insufficiencies requiring revascularization.
• Trial investigator deems the subject has no meaningful wound healing potential (e.g., advanced cancer, severe malnutrition) and/or has conditions that seriously compromise the subject's ability to complete the trial or a known history of non-adherence to medical care.
• Undergoing chemotherapy.
• History of radiation to the area of the index wound or ulcer, regardless of time since last radiation treatment.
• Use of investigational drugs or therapies within thirty (30) days before screening.
• On dialysis.
• Sensitivity, allergy, or contraindication to Miro3D and/or NPWT or its components.
• Presence of third-degree burns.
• Index wound or ulcer exhibiting worsening ischemia or gangrene at screening.
• Subjects moving toward palliative or comfort care.