The Effect of Catheter Protector on Catheter Dwell Time and Complications

August 19, 2026 updated by: Tuğba DOST, Karamanoğlu Mehmetbey University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The aim of this study was to determine the effect of IV House Ultradressing catheter protector application on the frequency of PVC change and complications in patients hospitalized in an oncology clinic and undergoing peripheral venous catheterization.

Research Question and Hypotheses H01: There is no difference in the frequency of PVC replacement between the IV House UltraDressing intervention group and the control group.

H02: There is no difference in PVK-related complications between the IV House UltraDressing intervention group and the control group.

H11: There is a difference in the frequency of PVK replacement between the IV House UltraDressing intervention group and the control group.

H12: There is a difference in PVK-related complications between the IV House UltraDressing intervention group and the control group.

MATERIALS AND METHODS

Type of Research

This study is planned to be conducted as a pretest-posttest, parallel group randomized controlled experimental design to evaluate the efficacy of IV House UltraDressing on the frequency of PVC change and catheter complications in patients treated in an oncology clinic. It was thought that the application of IV House UltraDressing would significantly reduce the frequency of PVC change and complications.

Population and Sample of the Study The research will be conducted with patients hospitalized in Necmettin Erbakan University Faculty of Medicine Oncology Clinic between October 2024 and March 2025. The sample size of the study was determined using the G. Power-3.1.9.2 program, with a power of 1-β=0.80 and an error level of α=0.05. Based on the data in the study of Büyükyılmaz et al. (2019), the effect size was calculated as d=0.72 based on the finding that there was a significant difference between the average duration of stay due to catheter-induced phlebitis in the intervention group (2.10 ± 1.55 days) and the average in the control group (1.27 ± 0.45 days). As a result of the sample size calculation made according to this assumption, 32 patients were predicted for each group. When it was predicted that 10% of the patients would leave the sample throughout the study, it was decided to include a total of 70 patients in the study, 35 patients in each group.

Randomization

The study group will be formed according to the inclusion and exclusion criteria. Patients who agree to participate in the study will be divided into two groups as intervention (IV House UltraDressing) and control group. The assignment of patients to the groups will be performed randomly by a statistician other than the researcher using a computer program (https://www.randomizer.org). Patients will be assigned by simple randomization method to protect confidentiality and prevent bias, and allocation to groups will be by block randomization method.

Blinding Patients will be informed about the study without disclosing which group they are in and their consent will be obtained. The researcher collecting the data for the study will be informed by telephone by an independent person after the written consent of the patients has been obtained and the pre-test data has been collected. Since the researcher manages the implementation process of the study, researcher blinding will not be possible.

The study will also be blinded in terms of statistical analysis. The data will be recorded on the computer by the researcher as group A and group B without using the terms experimental and control group. Data analyses will be performed by a statistician other than the randomizer.

Data Sources and Data Collection Method

The research data will be collected with the Introductory Information Form, which inquires the descriptive characteristics of the patients prepared by the researcher, and the PVK Follow-up Form.

Introductory Information Form: This part of the data collection form prepared by the researcher includes information such as the patient's age, gender, height, weight, hospitalization diagnosis, hospitalization date, and chronic diseases.

PVC Follow-up Form: The PNC follow-up form prepared by the researcher includes information on the date of insertion and removal of the PNC, the anatomical region where the PNC was inserted, the catheter number used, the duration of stay in the vein, the reason for changing the catheter (phlebitis, infiltration, extravasation, dislocation, catheter occlusion and catheter folding), the medications and IV fluids given, the status of blood product administration and the degree of phlebitis.

Phlebitis Assessment Scale: Phlebitis will be diagnosed with the phlebitis assessment scale developed by the Intravenous Nurses Association. The degree of phlebitis will be evaluated by measuring the width of the phlebitis area with a transparent millimeter ruler used by the investigators. The scale includes grading steps from 0 to 4 by observing the symptoms that can be seen at each stage of phlebitis.

Phlebitis with this scale:

  • 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 as a cable, Grade 4: redness, pain and/or edema at the catheter entry site, red line, palpation of the vein as a cable and longer than 2.5 cm, purulent discharge.

Research Implementation

The study will be conducted between October 2024 and March 2025. The study, which is planned as intervention and control groups, will start with the patients who have PVK implanted and who have informed that they agree to participate in the study. The data in both groups will be collected by the researcher every 24 hours and by the clinic nurses every 8 hours by interview and observation method. In the study, the duration of stay in the vein of a single catheter and newly opened catheter will be evaluated. In addition, a single vascular access will be evaluated in patients with more than one vascular access. The IV access will be performed by the nurse working in the clinic.

Intervention Group: 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 Peripheral Venous Catheter Observation Form and the effect of I.V. House UltraDressing will be evaluated.

Control Group: 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 Peripheral Venous Catheter observation 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. The time allocated for each patient is planned to last an average of 15 minutes.

Application tools

I.V. House UltraDressing: Developed by pediatric nurses Lisa Vallino and Betty Rozier in 1991, the I.V. House UltraDressing is an innovative product developed to provide, stabilize and protect long-term catheter safety. The product is a clear plastic dome that protects the catheter connection point. There is also a soft foam pad under the outer dome edge to ensure patient comfort (IV. House, Inc., St. Louis, MO, USA). The use of safe fixation methods is key in preventing complications related to PVK. Therefore, in this data collection method, in the intervention group, after filling out the introductory information form, IV. House UltraDressing will be applied to the inserted PVC and the frequency of catheter change and catheter-related complications will be evaluated and recorded in the PVC follow-up form.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
69

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Tuğba DOST, Öğr. Gör. Dr.
  • Phone Number: +90506+5031187 +905065031187
  • Email: t.demiroglu1@gmail.com

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
up to 1 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
up to 1 weeks
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
up to 1 weeks
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).
up to 1 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Karamanoğlu Mehmetbey University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: BETÜL TOSUN, DOÇ. DR., Karamanoğlu Mehmetbey University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 15, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 22, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 22, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 14, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 5, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Karamanoğlu Mehmetbey üni

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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