RecruitingACTRN12624000366550

Promoting haemostasis for central venous access devices: a randomised controlled trial

Promoting haemostasis for central venous access devices: a comparison of Statseal products with standard dressing care in adult inpatients to assess impact on dressing failure.


Sponsor

University of Wollongong

Enrollment

160 participants

Start Date

Jun 26, 2024

Study Type

Interventional

Conditions

Summary

When a central venous access device (CVAD – incorporates both centrally and peripherally inserted central catheters) is inserted, it breaches the body’s protective barrier – the skin. Together with the patient’s intrinsic risk factors associated with their illness (e.g., cancer and deranged metabolic function such as in critical illness), this places them at risk of persistent bleeding at the catheter exit site and systemic infections. These complications are highly correlated; bleeding at the insertion site causes dressing disruption, which is associated with an increased risk for central line-associated bloodstream infections (CLABSI). Potassium ferrate haemostatic discs and powder (StatSeal®, Biolife, Sarasota, Florida) contain a strong haemostatic agent which has primarily been used to promote haemostasis post-interventional vascular procedures and interventional cardiology. The haemostatic disc and powder also has the option of being applied at the CVAD skin exit site, however, its role to prevent haemostasis and promote dressing integrity (thereby reducing the risk of infection with longer-dwelling venous access devices), is yet to be explored. To provide further evidence and inform clinical practice, it is important to address this evidence-practice gap and test the safety and efficacy of the potassium ferrate products in promoting haemostasis and preventing dressing disruption for CVADs.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria4

  • Patient is
  • 18 years or older
  • Expected to require a CVAD for 48 hours or more
  • Currently an admitted patient or expected to be admitted to the hospital within 24 hours

Exclusion Criteria5

  • Patient has
  • Burned or scarred skin at the CVAD insertion site
  • A known allergy to Chlorhexidine, potassium ferrate, or transparent dressing adhesives
  • Been commenced on end-of-life pathway
  • Previously enrolled in this study

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Interventions

Intervention arm: StatSeal (potassium ferrate) disc or powder (Biolife, Sarasota, Florida), plus site-specific securement and dressing, see below. Application of disc vs powder will be at clinician d

Intervention arm: StatSeal (potassium ferrate) disc or powder (Biolife, Sarasota, Florida), plus site-specific securement and dressing, see below. Application of disc vs powder will be at clinician discretion. The clinician (doctor or nurse) inserting the device will apply the StatSeal product. StatSeal will only be applied once at the application of the initial dressing. Appropriate application of the intervention will be monitored by the research nurse. Liverpool Hospital (Site 1): Securement (e.g. StatLock, SecurAcath or suture) Dressing (e.g. 'Tegaderm CHG' (chlorhexidine gluconate) dressing) Royal Brisbane and Women's Hospital (Site 2): Securement (e.g. Statlock) Dressing (e.g. 'Tegaderm IV Advanced' + 'Biopatch disc')


Locations(2)

Liverpool Hospital - Liverpool

NSW,QLD, Australia

Royal Brisbane & Womens Hospital - Herston

NSW,QLD, Australia

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ACTRN12624000366550