Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06451185
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-06-05
Brief Title:
Statseal for Central Venous Catheter Insertion Sites in Critical Care
Sponsor:
Liverpool Heart and Chest Hospital NHS Foundation Trust
Organization:
Liverpool Heart and Chest Hospital NHS Foundation Trust
Study Overview
Official Title:
An Adaptive Randomised Controlled Trial Performed in a Cardiothoracic Theatre and Critical Care Setting to Investigate the Integrity and Durability of Standard Care Dressings Compared With Use of an Additional Haemostatic Powder to Cover and Protect Central Venous Catheter Insertion Sites
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SCENIC
Brief 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 reasons 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 participants 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
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 reasons 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 participants 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
Detailed 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 11 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
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 11 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None