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

Miromatrix Medical

Status: Withdrawn

Conditions: Complex Wound

Treatments: Other: Negative Pressure Wound Therapy (NPWT); Other: MIRODERM Application(s); Other: Standard Care

Study type: Interventional

Funder types: Industry

Identifiers

NCT02732548

2016001

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

NPWT Only

Active Comparator group

Description:

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.

Treatment:

Other: Standard Care

Other: Negative Pressure Wound Therapy (NPWT)

NPWT + MIRODERM

Experimental group

Description:

Subjects in this arm will receive NPWT and standard care, plus application(s) of the MIRODERM product.

Treatment:

Other: Standard Care

Other: Negative Pressure Wound Therapy (NPWT)

Other: MIRODERM Application(s)