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

July 14, 2017 updated by: Miromatrix Medical Inc.

MIRODERM™ for Complex Wounds in an Inpatient Setting

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Other: Negative Pressure Wound Therapy (NPWT)
Other: Standard Care
wound measurement, debridement, photography of wound, moist wound environment, infection management, nutritional support
Experimental: NPWT + MIRODERM
Subjects in this arm will receive NPWT and standard care, plus application(s) of the MIRODERM product.
Other: Negative Pressure Wound Therapy (NPWT)
Other: Standard Care
wound measurement, debridement, photography of wound, moist wound environment, infection management, nutritional support
Other: MIRODERM Application(s)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportion of subjects that have had an autograft or delayed primary closure procedure for the study wound by Week 6.
Time Frame: 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.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Miromatrix Medical Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

July 1, 2017

Study Registration Dates

First Submitted

March 31, 2016

First Submitted That Met QC Criteria

April 4, 2016

First Posted (Estimate)

April 8, 2016

Study Record Updates

Last Update Posted (Actual)

July 19, 2017

Last Update Submitted That Met QC Criteria

July 14, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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