A clinical evaluation of a CVC securement device
Research type
Research Study
Full title
A clinical evaluation of two central venous catheter stabilization systems
IRAS ID
166518
Contact name
Tony Whitehouse
Contact email
Sponsor organisation
University Hospitals Birmingham NHS Foundation Trust
Duration of Study in the UK
0 years, 4 months, 0 days
Research summary
Central venous catheters (CVC) are inserted into many patients for the administration of treatment and haemodynamic monitoring. 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 evaluation.
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 proposed randomized clinical study will evaluate a CE marked CVC securement device, which consists of a moulded plastic on an adhesive base, to secure CVC inserted into adult critical care patients. This is a feasibility study to assess safety of the device, whether the proposed study parameters are appropriate and measurable, and the securement device is acceptable to clinical users.
Following informed written consent, the patient who require a CVC as part of their clinical management, will be randomized to have either sutures or the CVC securement device applied to secure the CVC. The patient will be observed for any CVC related complications and CVC placement will be measured daily. Comfort of the patient and user acceptability will be evaluated where appropriate.
The study will be undertaken in a large teaching hospital in the UK. A total of 42 patients will be enrolled. The study will also be undertaken at three other European hospitals (in France and Spain). The results from all of these independent studies will be collated and analysed collectively.REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
15/NW/0185
Date of REC Opinion
23 Mar 2015
REC opinion
Favourable Opinion