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Completed

NCT Number: NCT06675786

The Effect of Catheter Protector on Catheter Dwell Time and Complications

This study assessed the impact of IV House UltraDressing on PIVC dwell time and related complications in adult oncology patients.Adults hospitalised on an oncology ward between October 15, 2024 and May 22, 2025 were randomly allocated to an intervention group (transparent dressing plus IV House UltraDressing) or a control group (transparent dressing only). Data were collected using descriptive and catheter monitoring forms, and phlebitis was assessed using a 0-4 grading system.Outcomes included catheter dwell time, complication-related removals, and the distribution of non-infectious complications.

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Key information

Conditions

Peripheral Catheterization Cardiovascular Diseases Complications Peripheral Vascular Diseases Phlebitis Vascular Diseases Vasculitis

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Necmettin Erbakan University

Konya, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Inclusion Criteria
  • Hospitalized in the oncology clinic
  • The one with the PVK attached,
  • Volunteered to participate in the research,
  • Treated in the same clinic during the study period,
  • No verbal, perceptual and visual communication problems,
  • 22-24 G (Blue) size catheter used,
  • Between the ages of 18 and 65,
  • Literate, -- Patients without scar tissue, infection, hematoma, edema at the sites to be used for PVK placement and successful PIVC placement on their first attemptwere included in the study.

Exculision Criteria:

  • - With a clotting disorder,
  • Patients with problems with skin integrity or limb movement such as scar tissue, infection, hematoma, edema at the PVK site,
  • Blood or blood products given through a catheter,
  • Patients who wanted to leave, were referred to a different clinic or discharged during the study were excluded from the study.

Treatment and study plan

I.V. House UltraDressing

Device

I.V. House UltraDressing (I.V. House, Inc., St. Louis, MO, USA) will be applied according to the manufacturer's instructions and secured with an anti-slip tape without the need for further taping. It is intended to prevent complications such as catheter-related displacement, phlebitis, infiltration, extravasation, catheter occlusion, and folding of PVCs.

Primary outcomes

  1. PIVC Monitoring Form

    Time frame: up to 1 weeks

    This form is completed with the dates/times of catheter insertion and removal to determine how many days the catheter remained in the patient. This form also includes sections evaluating the anatomical insertion site, catheter diameter, duration of stay, reasons for catheter replacement, extravasation, obstruction, kinking, and displacement.

Secondary outcomes

  1. Phlebitis Assessment Scale

    Time frame: up to 1 weeks

    The scale includes grading steps from 0 to 4, with observation of symptoms that can be seen at each stage of phlebitis.

    With this scale, phlebitis is evaluated as:

    • Grade 0: no symptoms,
    • Grade 1: redness and/or pain at the catheter entry site,
    • Grade 2: redness, pain and/or edema at the catheter entry site,
    • Grade 3: redness, pain and/or edema at the catheter entry site, red line, palpation of the vein in the form of a cable, Grade 4: redness, pain and/or edema at the catheter entry site, red line, palpation of the vein in the form of a cable and longer than 2.5 cm, purulent discharge.

  2. Infiltration Scale

    Time frame: up to 1 weeks

    Infiltration was assessed using a 0-4 grading system throughout data collection. Grade 0 indicated no signs or symptoms of infiltration, while Grades 1-4 represented progressively increasing severity based on clinical findings, including edema, skin changes, pain, and circulatory impairment

  3. PIVC Monitoring Form

    Time frame: up to 1 weeks

    Sections in this form are completed to evaluate the reasons for catheter changes, extravasation, obstruction, kinking, and displacement. This form also includes sections to determine the anatomical insertion site, catheter diameter, and the number of days the catheter remained in place (dates/times).

Sponsors and collaborators

Lead sponsor

Karamanoğlu Mehmetbey University

Other

Registry information

Official study title

Effect of a Catheter Protector on Dwell Time and Complications of Peripheral Intravenous Catheters in Oncology Patients: A Randomised Controlled Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 5, 2024
Registry last updated
Aug 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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