Dura Mater Nick Cut or TearNCT02225080

Duragen® Secure Post Marketing Clinical Follow-up (PMCF)

An observational study of Dura Mater Nick Cut or Tear and Surgery, run by Integra LifeSciences Corporation at 5 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to gather information about post-market performance of DuraGen Secure.The aim of this post market clinical follow-up (PMCF) is to obtain post market clinical data to evaluate the presence of unintended residual risks associated with the use of DuraGen Secure that were not anticipated or… Read more about this study

Who is it for?: Any age
Conditions the study is for: Dura Mater Nick Cut or Tear, Surgery
How many people: 100 participants
Where: 5 sitesin 4 countries
Study dates: Oct 2014to Jun 2016
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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Neurgosurgery service in Hospital

Who may be able to join

Patient who have undergone a neurosurgical procedure where DuraGen® Secure has been implanted

Who cannot join

Patient who does not agree to allow collection of his/her medical data

Trial locations and contacts

5 sites in 4 countries.

Country

City, postcode or hospital

5 sites in 4 countries

Spain2 sites

Hospital Universitario 12 de Octubre
Madrid
Hospital Universitario La Fe
Valencia

Other trials in Spain

France1 site

Hopital Lariboisière
Paris

Other trials in France

Germany1 site

die Charité - Universitätsmedizin Berlin
Berlin

Other trials in Germany

United Kingdom1 site

National Hospital for Neurology and Neurosurgery
London

Other trials in United Kingdom

About this study

Conditions: Dura Mater Nick Cut or Tear, Surgery
Medical subject headings: Lacerations

What participants receive

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

Study groups in NCT02225080
Study group	Role	What they receive
Duragen Secure		Have undergone a neurosurgical procedure where DuraGen® Secure has been implanted

What is being measured

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

Patient's Outcome
Patient outcome from the procedure (recovered without sequelae, ongoing with medical intervention, ongoing with surgical intervention, deceased, other)
Measured: Day 30

Secondary outcomes (3)

Occurence of Adverse Event
Adverse event that occured 72 hours post-operatively
Measured: first 72 hours post-op
Occurence of Adverse Event
Adverse event that occured between days 4-14 post-operatively
Measured: between days 4-14
Occurence of Adverse Event
Adverse event that occured between days 15-30 post-operatively
Measured: Between days 15-30

Timeline

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

Oct 2014Jun 2016

First posted25 Aug 2014 (estimated)
Study startOct 2014
Primary completionJun 2016
Study completionJun 2016

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 Dura Mater Nick Cut or TearStudies 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: Case only
Time perspective: Retrospective
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02225080
Sponsor's protocol ID: N-DURSEC-001
Status last verified: Sep 2018
First submitted: 28 Jul 2014
Last updated: 9 Oct 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Duragen® Secure Post Marketing Clinical Follow-up (PMCF)
ClinicalTrials.gov ID: NCT02225080
Acronym / sponsor ID: N-DURSEC-001
Conditions: Dura Mater Nick Cut or Tear, Surgery
Study type: Observational
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Integra LifeSciences CorporationIndustry (pharma, biotech, devices)
Study start: Oct 2014
Primary completion: Jun 2016 (actual)
Study completion: Jun 2016 (actual)
First posted: 25 Aug 2014 (estimated)
Results: Posted 16 Aug 2018

Clinical summary

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

Study design

Observational model: Case only
Time perspective: Retrospective
Number of arms: 1

Arm	Type	Receives
Duragen Secure	–	–Have undergone a neurosurgical procedure where DuraGen® Secure has been implanted

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Neurgosurgery service in Hospital

Key inclusion criteria (1 listed)

Patient who have undergone a neurosurgical procedure where DuraGen® Secure has been implanted

Key exclusion criteria (1 listed)

Patient who does not agree to allow collection of his/her medical data

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

Primary outcome

Patient's Outcome
Time frame: Day 30
Patient outcome from the procedure (recovered without sequelae, ongoing with medical intervention, ongoing with surgical intervention, deceased, other)

3 secondary outcomes

Occurence of Adverse Event
Time frame: first 72 hours post-op
Occurence of Adverse Event
Time frame: between days 4-14
Occurence of Adverse Event
Time frame: Between days 15-30

Results and safety

Results posted to the registry on 16 Aug 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Duragen Secure	100	100

Primary outcome: Patient's Outcome

Time frame: Day 30. Count of participants. Unit: Participants

Measure	Duragen Secure n = 100
Recovered without sequelae	73
Ongoing with medical intervention	7
Ongoing with surgical intervention	15
Deceased	3
Other	2

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Retrospective chart review of AE occured between surgery (Day 0) and file completion (between Day 30 and Day 60). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Duragen Secure	31 of 100 (31%)	0 of 100 (0%)	3 of 100

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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.

5 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Dura Mater Nick Cut or Tear and Surgery, run by Integra LifeSciences Corporation at 5 sites in 4 countries.

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 1 inclusion and 1 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: finished, as of the sponsor's last update on 9 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Spain, France, Germany, United Kingdom. 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 16 Aug 2018). 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?

Patient's Outcome (time frame: Day 30). 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 NCT02225080.

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 9 Oct 2018.