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

NCT02732548 | Withdrawn

• 1 other identifier: 2016001
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Other: Negative Pressure Wound Therapy (NPWT); Other: Standard Care

NPWT + MIRODERM

EXPERIMENTAL

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

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

Interventions

Negative Pressure Wound Therapy (NPWT) OTHER

NPWT + MIRODERM; NPWT Only

MIRODERM Application(s) OTHER

NPWT + MIRODERM

Standard Care OTHER

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

NPWT + MIRODERM; NPWT Only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Miromatrix Medical Inc.: lead

MeSH Terms

Interventions

Negative-Pressure Wound Therapy; Standard of Care

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Surgical Procedures, Operative; Wound Closure Techniques; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2016
• First Posted: April 8, 2016
• Study Start: January 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: July 1, 2017
• Last Updated: July 19, 2017

Record last verified: 2017-07