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Study was never initiated
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NPWT Only | Active Comparator | 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. |
|
| NPWT + MIRODERM | Experimental | Subjects in this arm will receive NPWT and standard care, plus application(s) of the MIRODERM product. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Negative Pressure Wound Therapy (NPWT) | Other |
| ||
| MIRODERM Application(s) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D054843 | Negative-Pressure Wound Therapy |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D004322 | Drainage |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D058106 | Wound Closure Techniques |
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| Other |
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| Standard Care | Other | wound measurement, debridement, photography of wound, moist wound environment, infection management, nutritional support |
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| D019984 |
| Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |