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RecruitingACTRN12625000137493

Supplemental Tackifier to Intravenous Catheter dressings to Keep intact Year-round in Kids (the STICKY Kids trial).

Sponsor

University of Queensland

Enrollment

104 participants

Start Date

Jun 17, 2025

Study Type

Interventional

Conditions

Central venous access device related adverse eventsCentral venous access device dressing complications

Summary

The objective of this study is to determine if the use of Mastisol Liquid Adhesive in conjunction with standard care reduces dressing disruption prior to scheduled weekly dressing change and is associated with fewer CVAD complications in children receiving in-home care.

Eligibility

Sex: Both males and femalesMin Age: 0 YearssMax Age: 18 Yearss

Inclusion Criteria5

  • Less than or equal to 18 years at recruitment
  • Patient expected to require central venous access device > 7 days
  • Requiring daily intravenous treatment in Hospital in the Home (HITH)
  • Informed consent to participate.
  • Vessel size appropriate for >3fr catheter or larger

Exclusion Criteria6

  • Under the care of child services (if unable to obtain consent)
  • Patient receiving end-of-life care.
  • Allergy to study product
  • Significantly impaired skin surrounding insertion site of vascular access device (e.g., catheter associated skin injury (CASI), eczema, burn, open wound)
  • <3fr device
  • Previous study participation for this central venous access device

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Interventions

Mastisol Liquid Adhesive (0.6ml individual vial blister pack) will be applied in conjunction with standard care dressing for central venous access devices (CVAD). This will occur each time the dressin

Mastisol Liquid Adhesive (0.6ml individual vial blister pack) will be applied in conjunction with standard care dressing for central venous access devices (CVAD). This will occur each time the dressing is required to be changed based on clinical requirement due to altered dressing integrity, and at least once weekly as per organisational policy. This will continue at each dressing change for up to 8 weeks or until the CVAD is removed (whichever occurs first). All dressing changes including application of the Mastisol Liquid Adhesive will be clinically managed by the Hospital in the Home (HITH) nursing team and will take place in the home care environment. Data will be collected by the HITH nursing team on a paper-based data collection tool which will be returned to the research team daily. Additional data will be collected from the electronic medical record, and directly from the patient/ family where required.

Locations(1)

Queensland Children's Hospital - South Brisbane

QLD, Australia

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ACTRN12625000137493