Complex WoundNCT02732548

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

A study testing Negative Pressure Wound Therapy (NPWT) and MIRODERM Application(s) in people with Complex Wound, run by Miromatrix Medical Inc..

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

Search all trials

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Complex Wound
What is being tested?: Negative Pressure Wound Therapy (NPWT) and MIRODERM Application(s)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: No sites listed yet
Study dates: Jan 2016to Jul 2017
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 13Show fewer

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

About this study

Official title: 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.

Conditions: Complex Wound
Being tested: Negative Pressure Wound Therapy (NPWT), MIRODERM Application(s), Standard Care

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Negative Pressure Wound Therapy (NPWT)Other
MIRODERM Application(s)Other
Standard CareOther
wound measurement, debridement, photography of wound, moist wound environment, infection management, nutritional support

Study groups in NCT02732548
Study group	Role	What they receive
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. Receives: 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. Receives: Other: Negative Pressure Wound Therapy (NPWT); Other: MIRODERM Application(s); Other: Standard Care

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2016Jul 2017

First posted8 Apr 2016 (estimated)
Study startJan 2016
Primary completionDec 2016 (estimated)
Study completionJul 2017 (estimated)

Why it stopped: Study was never initiated

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Complex WoundStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02732548
Sponsor's protocol ID: 2016001
Status last verified: Jul 2017
First submitted: 31 Mar 2016
Last updated: 19 Jul 2017
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruiting
Feasibility of a Web-based Single-session Intervention Combined With Ecological Momentary Assessment and Intervention for Patients With Complex Posttraumatic Stress Disorder Awaiting Inpatient Treatment
PTSD - Post Traumatic Stress Disorder, Depression
Enrolling by invitation
Accuracy of Positioning Guide and Customized Plate in Zygomaticomaxillary Complex Fracture
Zygomaticomaxillary Complex Fracture, Zygoma Fracture
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruitingPhase 2
Allopregnanolone in Chronic Complex Traumatic Brain Injury
Traumatic Brain Injury (TBI)
Active, not recruiting
Body-oriented Psychotherapy for Individuals With a History of Child Maltreatment and Trauma-related Symptoms
Safety, Psychological, Acceptability of Health Care

All Complex Wound trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: MIRODERM™ for Complex Wounds in an Inpatient Setting
ClinicalTrials.gov ID: NCT02732548
Acronym / sponsor ID: 2016001
Conditions: Complex Wound
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Study was never initiated
Enrolment: 0 participants (actual)
Lead sponsor: Miromatrix Medical Inc.Industry (pharma, biotech, devices)
Study start: Jan 2016
Primary completion: Dec 2016 (estimated)
Study completion: Jul 2017 (estimated)
First posted: 8 Apr 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
NPWT Only	Active comparator	Other: Negative Pressure Wound Therapy (NPWT), Other: Standard CareStudy 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.
NPWT + MIRODERM	Experimental	Other: Negative Pressure Wound Therapy (NPWT), Other: MIRODERM Application(s), Other: Standard CareSubjects in this arm will receive NPWT and standard care, plus application(s) of the MIRODERM product.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (13 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Negative Pressure Wound Therapy (NPWT)	Other	NPWT + MIRODERM, NPWT Only
MIRODERM Application(s)	Other	NPWT + MIRODERM
Standard Carewound measurement, debridement, photography of wound, moist wound environment, infection management, nutritional support	Other	NPWT + MIRODERM, NPWT Only

Primary outcome

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.

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2017.

Related trials for Complex Wound

Not yet recruiting
Feasibility of a Web-based Single-session Intervention Combined With Ecological Momentary Assessment and Intervention for Patients With Complex Posttraumatic Stress Disorder Awaiting Inpatient Treatment
PTSD - Post Traumatic Stress Disorder, Depression
Enrolling by invitation
Accuracy of Positioning Guide and Customized Plate in Zygomaticomaxillary Complex Fracture
Zygomaticomaxillary Complex Fracture, Zygoma Fracture
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruitingPhase 2
Allopregnanolone in Chronic Complex Traumatic Brain Injury
Traumatic Brain Injury (TBI)
Active, not recruiting
Body-oriented Psychotherapy for Individuals With a History of Child Maltreatment and Trauma-related Symptoms
Safety, Psychological, Acceptability of Health Care

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A study testing Negative Pressure Wound Therapy (NPWT) and MIRODERM Application(s) in people with Complex Wound, run by Miromatrix Medical Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 19 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02732548.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2017.