WoundsNCT03632954

Cytal® Wound Matrix and MicroMatrix® Wound Study

An observational study of Wounds, run by Integra LifeSciences Corporation at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

This is an observational study to assess the safety and efficacy of MicroMatrix® alone or in combination with Cytal® Wound Matrix on primary measures of wound healing. Read more about this study

Who is it for?: Ages 21 years and older
Conditions the study is for: Wounds
What is being tested?: ACell Arm
Type of treatment: Medical device
How many people: 37 participants
Where: 1 siteUnited States
Study dates: 11 Dec 2018to 27 Jan 2020
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Study population: Patients will be selected from NYU Winthrop Hospital, including the outpatient Wound Healing Center clinic.

Who may be able to join

Subject has at least one wound that the treating physician determines may be treated with Cytal® with or without MicroMatrix®.
Subject is at least 21 years of age.
Subject is willing and able to adhere to protocol requirements and agrees to participate in the study program and comply with the study follow-up regimen.
Subject or legal representative is willing to provide informed consent.
For females of reproductive potential, confirmed negative urine pregnancy test at enrollment.

Who cannot join

Allergy or hypersensitivity to materials in porcine-based study products (per subject report) or personal preference.
Subject report of concurrent participation in another clinical trial that involves an investigational drug or device that would interfere with this study.
The subject has any condition that, in the Investigator's opinion, would warrant exclusion from the study or prevent the subject from completing the study.
The subject's wound shows evidence of infection as determined by the Principal Investigator (which may be indicated by the presence of: elevated WBC, pus, moderate or greater discharge, abnormal odor, or acute osteomyelitis).
Wound with exposed organs or hardware.
Wound with burn etiology.

Trial locations and contacts

1 site in 1 country.

United States1 site

NYU Winthrop Hospital
Long Island City, New York, 11501

Other trials in United States

About this study

Official title: Use of Cytal® Wound Matrix and MicroMatrix® for the Management of Wounds

This is an observational study to assess the safety and efficacy of MicroMatrix® alone or in combination with Cytal® Wound Matrix on primary measures of wound healing.

Read the detailed description

A single-site, prospective, observational clinical study of Cytal® Wound Matrix alone or in combination with MicroMatrix® for the management of wounds. Up to 100 patients with multiple wound types including but not limited to, venous ulcers, diabetic foot ulcers, trauma wounds, and external surgical wounds will be treated either with Cytal® Wound Matrix alone or with Cytal® Wound Matrix and MicroMatrix® for wounds exceeding 3mm in depth. Wound healing efficacy, effect of treatment on patient-reported quality of life, complete wound management, wound-related adverse event, and wound pathology will be measured. The protocol defined patient follow-up is 12 months.

Conditions: Wounds
Being tested: ACell Arm
Keywords: Wounds, ACell, ACell MicroMatrix®, ACell Cytal® Wound Matrix, Extracellular Matrix, Urinary Bladder Matrix
Medical subject headings: Wounds and Injuries

What participants receive

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

ACell ArmDevice
Cytal® Wound Matrix and/or MicroMatrix®

Study groups in NCT03632954
Study group	Role	What they receive
ACell Arm		Cytal® Wound Matrix and/or MicroMatrix® Cytal® Wound Matrix 1-Layer is composed of porcine-derived extracellular matrix also known as urinary bladder matrix. It is intended for the management of a variety of wounds. The individual device is intended for one time use. MicroMatrix® is composed of a porcine-derived extracellular matrix known as urinary bladder matrix and is intended for the management of a variety of wounds. The devices are supplied in particle form in masses up to 1000mg. It is intended for one-time use. Receives: Device: ACell Arm

What is being measured

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

Number of Participants With Completely Healed Wounds
Assess number of participants with completely healed wounds, defined as 100% epithelialization with no drainage.
Measured: Up to 12 weeks
Wound Size Change
Assess wound size at specified intervals. Number of wounds with 40% reduction by week 4, 60% by week 8, and 80% by week 12.
Measured: Up to 12 weeks

Secondary outcomes (8)

Time to Complete Wound Closure
Determine time to complete wound closure using Silhouette Star camera system.
Measured: up to 52 week visit (until study completion)
Wound Characteristics
Identify wound characteristics as determined by granulation tissue quality and presence/quantity of exudate.
Measured: up to 52 week visit (until study completion)
Incidence of Bridging
Bridging to definitive closure or transition to cellular therapy
Measured: up to 52 week visit (until study completion)
Visual Analogue Scale (VAS) for Pain
VAS is a psychometric response scale that measures subjective characteristics or attitudes regarding perceived pain levels from participants. Participants are asked to draw a line on a 10cm horizontal line indicating what their current pain level would be. The distance between the start of the horizontal line to the vertical line is calculated in mm with a higher score (100mm) indicating a greater pain intensity.
Measured: Up to 52 week visit (until study completion)
Wound Quality of Life (W-QOL)
W-QOL is a 17-item Likert style questionnaire that measures 3 subscales in a participant (Body, Psyche, and Everyday to then calculate an overall global score. An overall global score is obtained from averaging all items. Each item is coded with numbers 0 (not at all) to 4 (very much) with a higher score indicating a lower quality of life.
Measured: Up to 52 week visit (until study completion)
Katz Index of Independence in Activities of Daily Living (KATZ ADL)
The Katz ADL is a 6-item questionnaire measuring independence in activities of daily living such as bathing, dressing, toileting, transfers, feeding, and continence. Each item is dichotomized as either having a score of zero (i.e dependence) or one (i.e. independence). An overall score of 6 indicates full function and an overall score of 2 or less indicates severe functional impairment
Measured: Up to 52 week visit (until study completion)
Complete Wound Management
Assess the method of application of products and how it is secured as well as adjunctive treatments and dressing.
Measured: up to 52 week visit (until study completion)
Wound-Related Adverse Events
Number and type of wound-related adverse events as recorded on adverse event case report forms.
Measured: up to 52 week visit (until study completion)

Timeline

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

11 Dec 201827 Jan 2020

First posted16 Aug 2018
Study start11 Dec 2018
Primary completion27 Jan 2020
Study completion27 Jan 2020

Why it stopped: Sponsor Decision

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for WoundsStudies 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 37 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03632954
Sponsor's protocol ID: CR2017-012
Status last verified: Apr 2021
First submitted: 9 Aug 2018
Last updated: 11 May 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No: There is no plan to share IPD to other researchers at this time.

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?

See locations

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All Wounds trials

Study at a glance

From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Use of Cytal® Wound Matrix and MicroMatrix® for the Management of Wounds
ClinicalTrials.gov ID: NCT03632954
Acronym / sponsor ID: CR2017-012
Conditions: Wounds
Keywords: Wounds, ACell, ACell MicroMatrix®, ACell Cytal® Wound Matrix, Extracellular Matrix, Urinary Bladder Matrix
Study type: Observational
Recruitment status: TerminatedReason stopped: Sponsor Decision
Enrolment: 37 participants (actual)
Lead sponsor: Integra LifeSciences CorporationIndustry (pharma, biotech, devices)
Collaborators: Winthrop University Hospital
Study start: 11 Dec 2018 (actual)
Primary completion: 27 Jan 2020 (actual)
Study completion: 27 Jan 2020 (actual)
First posted: 16 Aug 2018 (actual)
Results: Posted 11 May 2021

Clinical summary

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

This is an observational study to assess the safety and efficacy of MicroMatrix® alone or in combination with Cytal® Wound Matrix on primary measures of wound healing.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
ACell Arm	–	Device: ACell ArmCytal® Wound Matrix and/or MicroMatrix® Cytal® Wound Matrix 1-Layer is composed of porcine-derived extracellular matrix also known as urinary bladder matrix. It is intended for the management of a variety of wounds. The individual device is intended for one time use. MicroMatrix® is composed of a porcine-derived extracellular matrix known as urinary bladder matrix and is intended for the management of a variety of wounds. The devices are supplied in particle form in masses up to 1000mg. It is intended for one-time use.

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients will be selected from NYU Winthrop Hospital, including the outpatient Wound Healing Center clinic.

Key inclusion criteria (5 listed)

Subject has at least one wound that the treating physician determines may be treated with Cytal® with or without MicroMatrix®.
Subject is at least 21 years of age.
Subject is willing and able to adhere to protocol requirements and agrees to participate in the study program and comply with the study follow-up regimen.
Subject or legal representative is willing to provide informed consent.
For females of reproductive potential, confirmed negative urine pregnancy test at enrollment.

Key exclusion criteria (6 listed)

Allergy or hypersensitivity to materials in porcine-based study products (per subject report) or personal preference.
Subject report of concurrent participation in another clinical trial that involves an investigational drug or device that would interfere with this study.
The subject has any condition that, in the Investigator's opinion, would warrant exclusion from the study or prevent the subject from completing the study.
The subject's wound shows evidence of infection as determined by the Principal Investigator (which may be indicated by the presence of: elevated WBC, pus, moderate or greater discharge, abnormal odor, or acute osteomyelitis).
Wound with exposed organs or hardware.

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
ACell ArmCytal® Wound Matrix and/or MicroMatrix®	Device	ACell Arm

Primary outcome

Number of Participants With Completely Healed Wounds
Time frame: Up to 12 weeks
Assess number of participants with completely healed wounds, defined as 100% epithelialization with no drainage.
Wound Size Change
Time frame: Up to 12 weeks
Assess wound size at specified intervals. Number of wounds with 40% reduction by week 4, 60% by week 8, and 80% by week 12.

8 secondary outcomes

Time to Complete Wound Closure
Time frame: up to 52 week visit (until study completion)
Wound Characteristics
Time frame: up to 52 week visit (until study completion)
Incidence of Bridging
Time frame: up to 52 week visit (until study completion)
Visual Analogue Scale (VAS) for Pain
Time frame: Up to 52 week visit (until study completion)
Wound Quality of Life (W-QOL)
Time frame: Up to 52 week visit (until study completion)
Katz Index of Independence in Activities of Daily Living (KATZ ADL)
Time frame: Up to 52 week visit (until study completion)
Complete Wound Management
Time frame: up to 52 week visit (until study completion)
Wound-Related Adverse Events
Time frame: up to 52 week visit (until study completion)

Results and safety

Results posted to the registry on 11 May 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ACell Arm	37	3

Primary outcome: Number of Participants With Completely Healed Wounds

Time frame: Up to 12 weeks. Count of participants. Unit: Participants

Measure	ACell Arm n = 23
Value	4

Population analysed: The study was terminated by Sponsor prior to completion, all enrolled subjects did not complete 12 weeks follow-up prior to termination.

Primary outcome: Wound Size Change

Time frame: Up to 12 weeks

Population analysed: Data was not collected and outcome measure analysis was not performed.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: 52 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ACell Arm	6 of 37 (16.2%)	17 of 37 (45.9%)	1 of 37

Limitations and caveats (from the sponsor): Due to early termination, additional primary, secondary, and tertiary endpoint analyses were not performed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. There is no plan to share IPD to other researchers at this time.

Related trials for Wounds

Not yet recruitingObservational study
Arterial Stiffness During Negative Pressure Wound Therapy for Abdominal Wall Wounds
Postoperative Abdominal Wall Wound Complications, Surgical Wound Infection
Recruiting
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Recruiting
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Not yet recruiting
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Enrolling by invitationObservational study
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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.

Allison Matthews study chair

Integra LifeSciences Corporation

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Wounds, run by Integra LifeSciences Corporation at 1 site in United States.

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 5 inclusion and 6 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: stopped early, as of the sponsor's last update on 11 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Yes. Results are posted in the registry (first posted 11 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Completely Healed Wounds (time frame: Up to 12 weeks). The study lists 2 primary outcomes in all. 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 NCT03632954.

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 11 May 2021.