Condition category
Signs and Symptoms
Date applied
08/07/2015
Date assigned
09/07/2015
Last edited
14/08/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Central venous catheters (CVC) are inserted into many patients for the administration of treatment and haemodynamic monitoring (for measuring blood pressure and oxygen levels in the blood) . Sutures (stitches) are frequently used to secure CVC onto the skin, however application of sutures carries a risk of needle stick injury to the clinician, discomfort to the patient and trauma at the CVC insertion site. Moreover, the sutures securing CVC are often highly colonized with bacteria despite scrupulous CVC site care, and may serve as a source for an infection. CVC movement may introduce microorganisms from the skin surface along the CVC and contribute to an infection. Therefore alternative securement methods for short term CVC needs to be tested. Alternative CVC securement methods are available, such as adhesive devices/tapes/dressings; however these have been used for securing CVC that are placed through veins in the arm. Knowledge of securement device for CVC, which are inserted into neck, chest or groin, is limited. This study will test the safety of the device, whether what is being measured is appropriate and measurable and whether the device is acceptable to clinical users.

Who can participate?
Adults (18 or over) being treated, or about to be treated, in a critical care unit and needing a CVC.

What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 have sutures securing their CVC. Those in group 2 have the CVC securement device applied to secure the CVC. The patients are observed for any CVC related complications and CVC placement is measured daily. Comfort of the patient and user acceptability is evaluated where appropriate.

What are the possible benefits and risks of participating?
Participants may not have any direct medical benefit from being in this study; however the information gained from this study will help improve the treatment of future patients who have a catheter inserted as part of their medical care. Catheter stabilization is recognised as an intervention to decrease the risk for phlebitis and catheter displacement, and may be advantageous in preventing catheter related bloodstream infections. Risks include skin irritation and damage to the skin, improper use of the catheter securement system or displacement of it, infection and air embolism.

Where is the study run from?
University Hospitals Birmingham NHS Foundation Trust (UK).

When is the study starting and how long is it expected to run for?
June 2015 to December 2015

Who is funding the study?
3M Deutschland GmbH

Who is the main contact?
Dr Tarja Karpanen

Trial website

Contact information

Type

Scientific

Primary contact

Dr Tarja Karpanen

ORCID ID

Contact details

University Hospitals Birmingham NHS Foundation Trust
Queen Elizabeth Hospital
Mindelsohn Way
Edgbaston
B15 2GW
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

18974

Study information

Scientific title

A clinical evaluation of two central venous catheter stabilization systems

Acronym

Study hypothesis

The aim of this feasibility study is to assess the safety of a new securement device for central venous catheters (CVC), to see whether the proposed study parameters are appropriate and measurable, and the securement device is acceptable to clinical users.

Ethics approval

NRES Committee North West – Greater Manchester South, 27/04/2015, ref: 15/NW/0185

Study design

Randomised; Interventional; Design type: Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Topic: Critical care; Subtopic: Critical care; Disease: All Critical care

Intervention

CVC securement: a short-term central venous catheter will be secured onto the skin using either sutures and a transparent dressing, or a sutureless securement system which consists of a molded plastic device with an adhesive backing and a transparent film dressing.

Intervention type

Device

Phase

Drug names

Primary outcome measures

Total number of catheter dislodgements. Recorded daily (for the duration of CVC placement) using standard clinical observation methods.

Secondary outcome measures

1. Number of complete catheter dislodgements (i.e. number of unplanned catheter removals)
2. Number of partial catheter dislodgement: (i.e. catheter migration at the skin insertion site but not resulting in unplanned catheter removal; measured in mm)
3. Securement device adherence onto skin and catheter (full or partial)
4. Number of catheters requiring immediate repositioning of securement device
5. Number of dressing changes per catheter
6. Number of reported unresolved occlusions of the catheter
7. Catheter insertion site visible on routine clinical inspection (yes or no)
8. Number of patients requiring an alternative catheter securement method to which the subject was originally selected
9. Reasons for requiring an alternative catheter securement method to which the subject was originally selected
10. Clinical staff satisfaction (questionnaire)
11. Patient comfort level: subjective (pain score if able to communicate) and objective evaluation (skin condition) on application and removal of the securement device

Recorded daily (for the duration of CVC placement) using standard clinical observation methods

Overall trial start date

22/06/2015

Overall trial end date

31/12/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. ≥18 years of age
2. Admitted, or to be admitted, to a critical care unit
3. Require a single, short-term, non-cuffed, non-tunnelled CVC (up to and including 12F in size) as part of their clinical care
4. Willing and able to provide written informed consent (or if their condition do not allow this their legally authorized representative willing and able to give the consent on their behalf)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 168; UK Sample Size: 42

Participant exclusion criteria

1. Confused (patients who have a positive CAMICU score or if confusion expected after sedation stopped)
2. Excessively perspiring (skin becomes moist within 2 minutes of drying)
3. Non adherent skin burn, trauma or other condition affecting the skin integrity in close proximity to the potential insertion site, so that the device/ suture is applied to the skin without any of these conditions
4. Underlying uncorrected bleeding diathesis
5. Known allergy to adhesives or device components
6. To have more than one catheter inserted at the same location
7. Pregnant or breastfeeding women
8. Past participants in this study

Recruitment start date

22/06/2015

Recruitment end date

31/12/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University Hospitals Birmingham NHS Foundation Trust
Birmingham
B15 2GW
United Kingdom

Trial participating centre

Bichat-Claude Bernard Hopital
Paris
75018
France

Trial participating centre

University Hospital (Centre Hospitalier Universitaire), Universite de Poitiers et Inserm
Poitiers
86021
France

Trial participating centre

University Hospital Arnau de Vilanova (University Hospital Arnau de Vilanova)
Lleida
25198
Spain

Sponsor information

Organisation

University Hospitals Birmingham NHS Foundation Trust

Sponsor details

Research and Development Department
Heritage Building (Queen Elizabeth Hospital)
Mindelsohn Way
Edgbaston
Birmingham
B15 2TH
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

3M Deutschland GmbH

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

This is a feasibility study. The results may be published in a scientific journal or presented at a scientific meeting.

Intention to publish date

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes