MIRODERM™ for Complex Wounds in an Inpatient Setting (MIRODERM CLOSure)

Study Overview
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Brief Summary
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This study is being conducted to collect data on the performance of Miromatrix Wound Matrix (MIRODERM) when used in the treatment of complex wounds in an inpatient setting.

Official Title
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MIRODERM™ for Complex Wounds in an Inpatient Setting

Conditions
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Complex Wound

Intervention / Treatment
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* Other: Negative Pressure Wound Therapy (NPWT)
* Other: MIRODERM Application(s)
* Other: Standard Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be at least 18 years old Have a complex study wound which will require an autograft or delayed primary closure procedure and which may or may not include tunneling and/or undermining Have a study wound with a total post-debridement surface area ≥50cm2 and ≤250cm2 with no dimension >25cm, and a minimum depth of ≥0.5cm Have a study wound which is expected to take at least 4 weeks to reach autograft or delayed primary closure using standard care and NPWT Have a study wound that will be treated with NPWT regardless of study participation Be in an inpatient setting Be able and willing to sign the consent form and comply with all study visits and procedures Exclusion Criteria: Be pregnant or be planning to become pregnant during the study Be contraindicated for NPWT (necrotic tissue with eschar present, untreated osteomyelitis, non-enteric and unexplored fistulas, malignancy in the wound, exposed vasculature, exposed nerves, exposed anastomotic site, exposed organs) Be immunocompromised or at risk of immunosuppression (e.g. be HIV positive, be experiencing organ rejection, be a recent, current, or anticipated chemotherapy recipient) as determined by the Investigator Be taking a Tumor Necrosis Factor (TNF) blocker Be participating in another research study Have a sensitivity to porcine material Have a life expectancy of less than 1 year Have a study wound which is a third degree burn wound Have a study wound that is infected Have a study wound that is a pressure ulcer/wound Have a study wound with sinus tract(s) leading to other open area(s) Have a wound that is being treated or expected to be treated with either HBOT or topical wound oxygen therapy Have a study wound which has been treated with a cellular and/or tissue-based product within last 30 days

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NPWT Only<br>Study subjects who are randomized to the control arm will be treated with Negative Pressure Wound Therapy (NPWT) and additional standard care treatments. No cellular or acellular biological tissue scaffold will be allowed for subjects in this study arm for the first 6 weeks of the study. Subjects who are randomized to this arm and who do not experience at least a 50% surface area reduction of the study wound by the 6 week study visit will have the option to cross over into the NPWT + MIRODERM treatment arm. | Other: Negative Pressure Wound Therapy (NPWT)<br> <br> Other: Standard Care<br>* wound measurement, debridement, photography of wound, moist wound environment, infection management, nutritional support<br>|
| Experimental: NPWT + MIRODERM<br>Subjects in this arm will receive NPWT and standard care, plus application(s) of the MIRODERM product. | Other: Negative Pressure Wound Therapy (NPWT)<br> <br> Other: MIRODERM Application(s)<br> <br> Other: Standard Care<br>* wound measurement, debridement, photography of wound, moist wound environment, infection management, nutritional support<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of subjects that have had an autograft or delayed primary closure procedure for the study wound by Week 6. | The primary endpoint is the proportion of subjects that have had an autograft or delayed primary closure procedure for the study wound by the 6 week visit. | 6 weeks |