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The Effect of Catheter Protector on Catheter Dwell Time and Complications

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06675786
Enrollment
69
Registered
2024-11-05
Start date
2024-10-15
Completion date
2025-05-22
Last updated
2026-08-20

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

Conditions

Complications, Peripheral Catheterization

Keywords

Peripheral Venous Catheterization, IV House, Complication, Phlebitis

Brief 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.

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.

Sponsors

Karamanoğlu Mehmetbey University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Patients will be informed about the study and their consent will be obtained without revealing which group they are in. A blind technique will also be applied in terms of statistical analysis in the study. Data will be recorded on the computer as Group A and Group B by the researcher without using the terms experimental and control group. Data analyses will be performed by a statistician other than the person who performed the randomization.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
PIVC Monitoring Formup to 1 weeksThis 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

MeasureTime frameDescription
Phlebitis Assessment Scaleup to 1 weeksThe 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.
Infiltration Scaleup to 1 weeksInfiltration 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
PIVC Monitoring Formup to 1 weeksSections 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).

Countries

Turkey (Türkiye)

Contacts

PRINCIPAL_INVESTIGATORBETÜL TOSUN, DOÇ. DR.

Karamanoğlu Mehmetbey University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 21, 2026