Clinical Trials Logo

Clinical Trial Summary

All participants in this clinical trial will be undergoing surgery and will have a central venous catheter (also known as a central line) placed in the large vein in the neck as part of their routine care. The purpose of this clinical trial is to compare different ways of dressing central lines. In current standard care, central lines are stitched in place and covered with a protective transparent dressing. This standard care will be compared with the addition of a haemostatic powder beneath the transparent dressing. This powder product aids clotting at the level of the skin, meaning that it prevents or reduces bleeding while helping to maintain a dry and protected environment. The main questions this clinical trial aims to answer are: - Will the addition of a haemostatic powder increase the durability of central line dressings? - What proportion of dressings required an unplanned change? - The reason(s) for any unplanned change - The incidence of bleeding around central line insertion sites - Were any skin problems observed once the dressings were removed? Once the dressings are applied, all central lines sites will be monitored as part of the participant's routine care. Participation in the clinical trial lasts as long as the first central line dressing remains in place. Central line dressings currently and routinely remain in place for up to, but not more than seven days. After this period, there will be no need for any research-related observations. Routine care will continue and will not be affected by the research. Participants will not be asked to make any extra visits over and above those needed for routine care.


Clinical Trial Description

Current established practice recommends that central venous catheter (CVC) dressings that are clean dry and intact can safely remain in place for up to seven days. Bleeding and moisture at CVC insertion sites can lead to poor dressing adherence and to an environment favourable for microbial growth. Additional unplanned interactions are provoked such as undressing, cleaning and redressing the site; in some circumstances it may be necessary to change or to re-site the catheter. Each of these factors may increase the risk of infection while consuming additional healthcare time and resource. The study will recruit patients undergoing surgery in a tertiary cardiothoracic hospital. Those selected will have planned CVC insertion. The majority of patients will have an increased bleeding risk due to the nature of cardiac surgery, usually requiring a number of agents to reduce their risk of thrombosis. Whilst there is a suitably individualised and patient-specific assessment of risk, the internal jugular is the preferred vein for a large proportion of our patients. Haemostasis is the mechanism by which bleeding is stopped by the formation of a clot. In anticoagulated patients, clot formation is prolonged resulting in frequent oozing and bleeding around CVC insertion sites and to the soiling of dressings. Serous exudate, clammy skin and diaphoresis present additional challenges in this patient cohort. StatSeal® is an approved and commercially available haemostatic powder product indicated for the temporary external control of bleeding. Recommended application is at CVC insertion, prior to the site being covered with a transparent dressing. Comprising a hydrophilic polymer and potassium ferrate, once in contact with protein-rich body fluids, the mechanism of action of the powder is to dehydrate and to absorb exudate. This simultaneously forms a low pH seal barrier which is hostile to microbial penetration while also purporting to help maintain clean and dry environment beneath transparent dressings. The objective of the study is to compare current standard care with use of an additional haemostatic powder. Following the successful insertion of an internal jugular CVC in the theatre area, participants will be randomised in a 1:1 ratio into one of the following groups: 1. Current standard care group - where the site is covered with a transparent dressing. 2. Intervention group - where the powder will be applied around the CVC skin insertion site before being covered with the same transparent dressing. This is a low-intervention, low-risk pragmatic study. The consent seeking process is proportionate and adapted to the design of the study. Routine monitoring of each CVC site will follow. Each CVC insertion site will be observed from randomisation for a period of 168 hours (seven days) or up to the time of CVC removal or first dressing change (which ever event occurs soonest). The 7-day period has been selected as this would be the time of the first planned dressing change for the CVC placed at randomisation. Within this period, data will be collected to investigate the duration and integrity of each index dressing including the reasons for removal and, the skin status at removal. Data collection will be electronic and will be performed by medical, nursing and other suitably qualified and trained staff thus facilitating multidisciplinary collaboration and integration of research with everyday clinical practice. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06451185
Study type Interventional
Source Liverpool Heart and Chest Hospital NHS Foundation Trust
Contact Christine Mars, BSc
Phone +44 151 600 1616
Email christine.mars2@lhch.nhs.uk
Status Not yet recruiting
Phase N/A
Start date June 12, 2024
Completion date December 31, 2024

See also
  Status Clinical Trial Phase
Recruiting NCT05114551 - ICU Predictive Score of WEaning Success in Patients At Risk of Extubation Failure
Completed NCT05547646 - The Prevalence of Healthcare-associated Infection in Medical Intensive Care Units in Tunisia
Recruiting NCT03697785 - Weaning Algorithm for Mechanical VEntilation N/A
Completed NCT02922101 - Evaluation of the Effectiveness of an Audit and Feedback Intervention With Quality Improvement Toolbox in Intensive Care N/A
Completed NCT02902783 - DONATE-Pilot Study on ICU Management of Deceased Organ Donors
Completed NCT01885442 - TryCYCLE: A Pilot Study of Early In-bed Leg Cycle Ergometry in Mechanically Ventilated Patients N/A
Completed NCT01857986 - Evaluating Air Leak Detection in Intubated Patients N/A
Recruiting NCT05518955 - VR Integrated Into Multicomponent Interventions for Improving Sleep in ICU N/A
Recruiting NCT03810768 - Metabolomics Study on Postoperative Intensive Care Acquired Muscle Weakness
Completed NCT03295630 - Validity of an Actigraph Accelerometer Following Critical Illness N/A
Completed NCT05556811 - HEaling LIght Algorithms for the ICU Patient N/A
Recruiting NCT05702411 - Air Stacking Technique For Pulmonary Reexpansion N/A
Completed NCT02741453 - Bilateral Internal Jugular Veins Ultrasound Scanning Prior to CVC Placement N/A
Recruiting NCT04979897 - Impact on Mental, Physical, And Cognitive Functioning of a Critical Care sTay During the COVID-19 Pandemic
Completed NCT05281224 - Ventilator Tube Holder for Patients With a Tracheostomy
Withdrawn NCT02970903 - VitalPAD: an Intelligent Monitoring and Communication Device to Optimize Safety in the PICU N/A
Recruiting NCT02587273 - The Pharmacokinetics of Fentanyl in Intensive Care Patients Phase 4
Completed NCT02661607 - Point of Care Echocardiography Versus Chest Radiography for the Assessment of Central Venous Catheter Placement N/A
Completed NCT01479153 - Venous Site for Central Catheterization N/A
Recruiting NCT06110390 - High-flow Nasal Oxygen Therapy to Prevent Extubation Failure in Adult Trauma Intensive Care Patients N/A