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

Primary Purpose

Complex Wound

Status

Withdrawn

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Negative Pressure Wound Therapy (NPWT)

MIRODERM Application(s)

Standard Care

About this trial

This is an interventional treatment trial for Complex Wound

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

NPWT Only

NPWT + MIRODERM

Arm 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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02732548

First Posted

March 31, 2016

Last Updated

July 14, 2017

Sponsor

Miromatrix Medical Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02732548

Brief Title

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

Official Title

MIRODERM™ for Complex Wounds in an Inpatient Setting

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Withdrawn

Why Stopped

Study was never initiated

Study Start Date

January 2016 (undefined)

Primary Completion Date

December 2016 (Anticipated)

Study Completion Date

July 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Miromatrix Medical Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Complex Wound

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NPWT Only

Arm Type

Active Comparator

Arm Description

Arm Title

NPWT + MIRODERM

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Negative Pressure Wound Therapy (NPWT)

Intervention Type

Other

Intervention Name(s)

MIRODERM Application(s)

Intervention Type

Other

Intervention Name(s)

Standard Care

Intervention Description

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

Primary Outcome Measure Information:

Title

The proportion of subjects that have had an autograft or delayed primary closure procedure for the study wound by Week 6.

Description

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.

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

12. IPD Sharing Statement

Learn more about this trial

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

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