Condition category
Signs and Symptoms
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

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 2014 to June 2017

Who is funding the study?
3M Deutschland GmbH

Who is the main contact?
Dr Tarja Karpanen

Trial website

Contact information



Primary contact

Dr Tarja Karpanen


Contact details

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

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

A clinical evaluation of two central venous catheter stabilization systems


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


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

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


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


CVC securement: a short-term central venous catheter is 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



Drug names

Primary outcome measure

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


Overall trial end date


Reason abandoned (if study stopped)


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


Age group




Target number of participants

Planned Sample Size: 168; UK Sample Size: 42

Total final enrolment


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


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

University Hospitals Birmingham NHS Foundation Trust
B15 2GW
United Kingdom

Trial participating centre

Bichat-Claude Bernard Hopital

Trial participating centre

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

Trial participating centre

University Hospital Arnau de Vilanova (University Hospital Arnau de Vilanova)

Sponsor information


University Hospitals Birmingham NHS Foundation Trust

Sponsor details

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

Sponsor type

Hospital/treatment centre



Funder type


Funder name

3M Deutschland GmbH

Alternative name(s)

Funding Body Type

Funding Body Subtype


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.

IPD sharing statement:
The datasets are not made publicly available as consent from patients were not sought for data to be used for other research/sent outside of EU

Intention to publish date


Participant level data

Not expected to be available

Basic results (scientific)

See additional file (ISRCTN13939744_BasicResults_06Sep2018.pdf)

Publication list

2019 results in (added 23/04/2019)

Publication citations

Additional files

Editorial Notes

23/04/2019: The following changes have been made: 1. Publication reference added. 2. The total final enrolment has been added from the results publication. 06/09/2018: The basic results of this trial have been uploaded as an additional file 04/12/2017: Contact email address changed from to 30/11/2017: The overall trial dates have been updated from 22/06/2015-31/12/2015 to 18/06/2014-14/06/2017. The recruitment dates have been updated from 22/06/2015-31/12/2015 to 08/09/2015-31/01/2017.