Complex Wound
Conditions
Brief summary
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.
Interventions
OTHERMIRODERM Application(s)
OTHERStandard Care
wound measurement, debridement, photography of wound, moist wound environment, infection management, nutritional support
Sponsors
Miromatrix Medical Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of subjects that have had an autograft or delayed primary closure procedure for the study wound by Week 6. | 6 weeks | 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. |
Outcome results
None listed