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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.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624000366550
Acronym
PRESS
Enrollment
10
Registered
2024-03-28
Start date
2024-06-26
Completion date
Unknown
Last updated
2024-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 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): Securemen

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')

Sponsors

University of Wollongong
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patient is 1. 18 years or older 2. Expected to require a CVAD for 48 hours or more 3. Currently an admitted patient or expected to be admitted to the hospital within 24 hours

Exclusion criteria

Patient has 1. Burned or scarred skin at the CVAD insertion site 2. A known allergy to Chlorhexidine, potassium ferrate, or transparent dressing adhesives 3. Been commenced on end-of-life pathway 4. Previously enrolled in this study

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026