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CompletedNCT06675786Updated Aug 20, 2026

The Effect of Catheter Protector on Catheter Dwell Time and Complications

An interventional study of I.V. House UltraDressing in Peripheral Catheterization and Complications, sponsored by Karamanoğlu Mehmetbey University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-20.

Sponsored by Karamanoğlu Mehmetbey University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
69
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Peripheral Catheterization
  • Complications

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Keywords

  • Peripheral Venous Catheterization
  • IV House
  • Complication
  • Phlebitis
03

In context

Phlebitis

45 studies on the registry are indexed under Phlebitis; 9 are open to participants now.

This study's enrollment of 69 is below the median of 134 across 38 interventional studies indexed under Phlebitis.

Browse Phlebitis studies →

Lead sponsor

Karamanoğlu Mehmetbey University is the lead sponsor of 69 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
69 participants (actual)

Study arms

  • Experimental
    I.V. House UltraDressing

    The nurse who will perform the PVC will clean the area where the PVC will be applied with alcohol and cotton wool, let it dry and apply Teflon Introcan Safety I.V. Catheter No. 22-24 (B. Braun Medical Inc. Bethlehem, PA, USA) to the patients and apply the routine intravenous line fixation method of the clinic with a plaster. The patient with the PVC will then fill out an introductory information form. 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. Catheter-induced complications such as dislodgement, phlebitis, infiltration, extravasation, catheter occlusion and folding of PVCs will be observed and recorded on the PIVC Monitoring Form, Phlebitis Assessment Scale, and the Infiltration Scale and the effect of I.V. House UltraDressing will be evaluated.

    Device: I.V. House UltraDressing

  • No intervention
    Control

    The nurse who will perform the PVC application will clean the area where the PVC will be applied with alcohol and cotton wool and leave it to dry, and the patients in both groups will be applied with a Teflon Introcan Safety I.V. Catheter (B. Braun Medical Inc. Bethlehem, PA, USA) numbered 22-24 and the clinic's routine intravenous line fixation method of fixation with a plaster will be applied. After the PVC is inserted, the introductory information form will be filled out and the duration of the stay of the PVC in the vascular access, dislodgement status and catheter-related complications such as dislodgement, phlebitis, infiltration, extravasation, catheter occlusion and folding of the PVCs will be observed and recorded on the PIVC Monitoring Form, Phlebitis Assessment Scale, and the Infiltration Scale form prepared by the researcher. Patients will remain in the study as long as they are hospitalized in the clinic and their PVCs are inserted.

Interventions

  • DeviceI.V. House UltraDressing

    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.

06

What researchers measure

Primary outcomes

  1. PIVC Monitoring Form

    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.

    Time frame: up to 1 weeks

Secondary outcomes

  1. Phlebitis Assessment Scale

    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.

    Time frame: up to 1 weeks

  2. Infiltration Scale

    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

    Time frame: up to 1 weeks

  3. PIVC Monitoring Form

    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).

    Time frame: up to 1 weeks

07

Study locations

1 site
  • Necmettin Erbakan University
    Konya, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06675786
Lead sponsor
Karamanoğlu Mehmetbey University
Responsible party
Tuğba DOST (Principal Investigator, Karamanoğlu Mehmetbey University) — Principal investigator
First posted
Nov 5, 2024
Start date
Oct 15, 2024
Primary completion
May 22, 2025
Completion
May 22, 2025
Last update
Aug 20, 2026

Study contacts

BETÜL TOSUN, DOÇ. DR.
principal investigator · Karamanoğlu Mehmetbey University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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