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

Complex Wound Clinical Trial

Official title:

MIRODERM™ for Complex Wounds in an Inpatient Setting

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02732548
• Other study ID #: 2016001
• Status: Withdrawn
• Phase: N/A
• First received: March 31, 2016
• Last updated: July 14, 2017
• Start date: January 2016
• Est. completion date: July 2017

Study information

• Verified date: July 2017
• Source: Miromatrix Medical Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Complex Wound
• Wounds and Injuries

Intervention

Other:
• Negative Pressure Wound Therapy (NPWT)

• MIRODERM Application(s)

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Miromatrix Medical Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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