Wound
Conditions
Brief summary
The purpose of this research study is to evaluate the outcomes for patients managed with standard of care (SOC) wound treatments and those managed with standard of care treatment and tissue scaffolds, specifically Miro 3D. Tissue scaffolds like Miro 3D are 3-dimentional frameworks for collagen protein that provide structure and protection to help wounds heal.
Detailed description
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.
Interventions
OTHERStandard of Care Treatment or Standard of Care Treatment plus Miro3D Wound Matrix
Subjects with lower extremity three-dimensional tissue defects, including those resulting from elevated calf intra-compartmental hypertension treated with decompressive fasciotomies or serious NSSTIs of the foot or lower extremities (including the pelvis as part of the lower extremity). These defects must have been controlled with surgical debridement. Subjects will be randomized to either SOC alone or SOC plus the application of Miro3D tissue scaffolding.
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Subjects will be randomly assigned to receive one of the 2 study treatments: either standard of care alone or standard of care treatment with Miro 3D. Efficacy will be determined by quantifying wound closure and PAR toward closure. The trial will also examine cost of care, number of serial placements of Miro3D, and time to hospital discharge for acute wounds.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Subjects must fulfill all the following inclusion criteria to qualify for enrollment: 1. Men or women 18-90 years of age at enrollment. 2. Ability to sign consent by subject or LAR. 3. 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. 4. Subjects must agree to proper offloading and/or compression of the wound or ulcer throughout the trial. 5. Written informed consent is required for digital photo imaging. 6. 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. 7. 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: 1. The PAR of the pressure ulcer arm has reduced by 50% or more after four (4) weeks of SOC. 2. Wounds with active invasive infection not yet controlled in the opinion of a trial investigator. 3. Wounds with vascular insufficiencies requiring revascularization. 4. 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. 5. Undergoing chemotherapy. 6. History of radiation to the area of the index wound or ulcer, regardless of time since last radiation treatment. 7. Use of investigational drugs or therapies within thirty (30) days before screening. 8. On dialysis. 9. Sensitivity, allergy, or contraindication to Miro3D and/or NPWT or its components. 10. Presence of third-degree burns. 11. Index wound or ulcer exhibiting worsening ischemia or gangrene at screening. 12. Subjects moving toward palliative or comfort care.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of change defined as Percentage Area Reduction or PAR at four weeks after placement or not of the MIRO3D. | 4 weeks | Rate of change |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assess frequency of MIRO3D applications over a 12-week treatment period | 12 weeks | Frequency of MIRO3D applications |
| Assess cost of care, including operating room time and time to hospital discharge for acute wounds | 12 weeks | Cost of care (dollars as units of cost) |
| Assess NPWT use | 12 weeks | Frequency of NPWT use |
| Assess cellular findings from tissue sampling | 12 weeks | Prescence of bacteria or fungus, blood vessels and new healing cells on pathology |
| Assess antibiotic use | 12 weeks | Frequency of antibiotic use |
| Assess pain | 12 weeks | Subject-reported pain scores using Likert Scale, 0=No Pain - 10=Worst Possible Pain |
| Assess subject-reported ability to move to self-care | 12 weeks | Patients will report if they are able to change their dressing on their own without anyone's assistance versus others having to assist (including if home health was able to be stopped) and when this occurred in their treatment course. |
Countries
United States
Contacts
CONTACTAaron Day, RN
CONTACTStacey Reese, RN, BSN
PRINCIPAL_INVESTIGATORJohn Kirby, MD
Washington University School of Medicine
Outcome results
None listed