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

NCT ID: NCT02732548

Last Updated: 2017-07-19

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2017-07-31

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.

Conditions

Complex Wound

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NPWT Only

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.

Group Type: ACTIVE_COMPARATOR

Negative Pressure Wound Therapy (NPWT)

Intervention Type: OTHER

Standard Care

Intervention Type: OTHER

wound measurement, debridement, photography of wound, moist wound environment, infection management, nutritional support

NPWT + MIRODERM

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

Group Type: EXPERIMENTAL

Negative Pressure Wound Therapy (NPWT)

Intervention Type: OTHER

MIRODERM Application(s)

Intervention Type: OTHER

Standard Care

Intervention Type: OTHER

wound measurement, debridement, photography of wound, moist wound environment, infection management, nutritional support

Interventions

Negative Pressure Wound Therapy (NPWT)

Intervention Type: OTHER

MIRODERM Application(s)

Intervention Type: OTHER

Standard Care

wound measurement, debridement, photography of wound, moist wound environment, infection management, nutritional support

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Miromatrix Medical Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

2016001

Identifier Type: -

Identifier Source: org_study_id