BIP CVC Clinical Safety and Performance Study | NCT02811380

Studies
BIP CVC Clinical Safety and Performance Study

NCT02811380

Sponsor

Bactiguard AB

Status

Completed

Last Update Posted

Jun 23, 2016Estimated

Enrollment

36Actual

Phase

Phase 4

Conditions

Surgery
Central Line Associated Blood Stream Infections (CLABSI)

Interventions

BIP CVC
Uncoated Standard CVC

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2013

Primary Completion Date

Jan 2015Actual

Completion Date

Jan 2015Actual

First Submitted Date

Dec 23, 2014

First Submission Date that Met QC Criteria

Jun 21, 2016

First Posted Date

Jun 23, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 21, 2016

Last Update Posted Date

Jun 23, 2016Estimated

Name	Class
Karolinska University Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The primary objective of this trial was to determine Bactiguard coated BIP CVC's safety and performance and compare it to corresponding standard uncoated CVC.

Detailed Description

The primary objective of this study is to determine the safety for the medical device of 'BIP central venous catheter". Safety is assessed by evaluation of adverse events (according to ISO 14155:2011). Examples of CVC related common events are phlebitis, infection at the infection site, catheter related bacteremia/fungemia, septicemia, sepsis, thrombosis, lung emboli and pneumothorax.

The secondary objective is to assess the overall performance by evaluating if there were any CVC handling problems experienced by the physician/health care personnel.

Furthermore, an exploratory objective of this study is to assess coating and microbial colonization.

Included in the study were men and women aged 18 years or older undergoing elective standardized large surgery with a planned CVC catheterization in right or left jugular vein or subclavian vein planned for at least 3 days.

This study is a single-centre, randomized, single-blind, controlled study of tolerability and safety of BIP CVC with noble metal alloy coating.

All statistical analyses is performed using the SAS® System, version 9.3 or higher (SAS Institute Inc., Cary, NC, USA). Data is to be summarized using descriptive statistics.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BIP CVC	Experimental	Bactiguard Infection Protection Central Venous Catheter	Device: BIP CVC
Uncoated standard CVC	Placebo Comparator	Uncoated standard Central Venous Catheter	Device: Uncoated Standard CVC

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BIP CVC	Device	BIP CVC catheterization to minimize risk of infections for venous access during and after elective large surgery	BIP CVC

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assessment of safety by evaluation of CVC related adverse events and any problems in post operative course.	Overall assessment of safety by evaluation of CVC related adverse events and any problems in post operative course.	Through study completion, an average of 10 days

Secondary Outcomes

Measure	Description	Time Frame
Assessment of the overall performance	Overall assessment of device performance by evaluation of any CVC handling problems experienced by the physician/health care personnel.	Through study completion, an average of 10 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult men and women ≥ 18 years of age
Were, in the opinion of the investigator, able to communicate with and understand the trial personnel and comply with the requirements of the trial
Requiring CVC catheterization for venous access, via right (most often) or left jugular vein or subclavian vein, during and after elective large surgery (liver or pancreas resection or intestinal/bowel surgery) planned for at least 3 days
Had signed the informed consent

Exclusion Criteria:

Known transmissive blood disease
Known multiresistant bacterial colonization
Ongoing infection
Thromboembolism
Anti-coagulation treatment excluding prophylaxis
CVC during last 2 months
History of problems with CVC
Pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sigridur Kalman, MD PhD Prof	Karolinska University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Karolinska University Hospital, Dept. of Anesthesia and Intensive Care, Sweden		Stockholm	Huddinge	SE-141 86	Sweden

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003428	Cross Infection

Ancestor Terms

ID	Term
D007239	Infections
D007049	Iatrogenic Disease
D020969	Disease Attributes
D010335	Pathologic Processes

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Browse Branches

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