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

Not Applicable

Withdrawn

• Conditions: Complex Wound
• Interventions: Other: Negative Pressure Wound Therapy (NPWT); Other: Standard Care; Other: MIRODERM Application(s)

• Registration Number: NCT02732548
• Lead Sponsor: Miromatrix Medical Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-03-31
• Study First Submitted QC: 2016-04-04
• Study First Posted: 2016-04-08
• Primary Completion: 2016-12
• Status Verified: 2017-07
• Study Completion: 2017-07
• Last Update Submitted: 2017-07-14
• Last Update Posted: 2017-07-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NPWT Only	Standard Care	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	Negative Pressure Wound Therapy (NPWT)	Subjects in this arm will receive NPWT and standard care, plus application(s) of the MIRODERM product.
NPWT + MIRODERM	Standard Care	Subjects in this arm will receive NPWT and standard care, plus application(s) of the MIRODERM product.
NPWT Only	Negative Pressure Wound Therapy (NPWT)	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	MIRODERM Application(s)	Subjects in this arm will receive NPWT and standard care, plus application(s) of the MIRODERM product.

Primary Outcome Measures

Name	Time	Method
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.