Peripheral CatheterizationNCT06675786
The Effect of Catheter Protector on Catheter Dwell Time and Complications
A study testing I.V. House UltraDressing in people with Peripheral Catheterization and Complications, run by Karamanoğlu Mehmetbey University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Peripheral Catheterization, Complications
- What is being tested?
- I.V. House UltraDressing
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2024to 22 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
Show all 13Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Peripheral Catheterization, Complications
- Being tested
- I.V. House UltraDressing
- Keywords
- Peripheral Venous Catheterization, IV House, Complication, Phlebitis
- Medical subject headings
- Phlebitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I.V. House UltraDressingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| I.V. House UltraDressing | Experimental | 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. Receives: Device: I.V. House UltraDressing |
| Control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 1 weeks
Secondary outcomes (3)
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.
Measured: up to 1 weeks
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
Measured: up to 1 weeks
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).
Measured: up to 1 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start15 Oct 2024
- Primary completion22 May 2025
- Study completion22 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral CatheterizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karamanoğlu Mehmetbey University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuğba DOST, Karamanoğlu Mehmetbey University
- Investigators
- BETÜL TOSUN, DOÇ. DR., Principal investigator, Karamanoğlu Mehmetbey University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06675786
- Sponsor's protocol ID
- Karamanoğlu Mehmetbey üni
- Status last verified
- Aug 2026
- First submitted
- 14 Oct 2024
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Catheter Protector on Dwell Time and Complications of Peripheral Intravenous Catheters in Oncology Patients: A Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT06675786
- Acronym / sponsor ID
- Karamanoğlu Mehmetbey üni
- Conditions
- Peripheral Catheterization, Complications
- Keywords
- Peripheral Venous Catheterization, IV House, Complication, Phlebitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Karamanoğlu Mehmetbey UniversityUniversity, hospital or other
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 22 May 2025 (actual)
- Study completion
- 22 May 2025 (actual)
- First posted
- 5 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I.V. House UltraDressing | Experimental | Device: I.V. House UltraDressingThe 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. |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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,
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| I.V. House UltraDressingI.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. | Device | I.V. House UltraDressing |
Primary outcome
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.
3 secondary outcomes
Phlebitis Assessment Scale
Time frame: up to 1 weeks
Infiltration Scale
Time frame: up to 1 weeks
PIVC Monitoring Form
Time frame: up to 1 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Peripheral Catheterization
Enrolling by invitation
TruVascular Access - Ultrasound-Guided Vascular Access Study
Peripheral Venous Catheterization, Difficult Intravenous Access
Not yet recruiting
Near-Infrared Light for Peripheral Venous Catheterization in Adults With Difficult Venous Access
Difficult Venous Access
Recruiting
Comparison of the Effectiveness of Ultrasound-guided Techniques and Infrared Illumination, Compared With the Standard Approach to Peripheral Venous Line Placement in People With Difficult Venous Access
Peripheral Venous Catheterization
Recruiting
Single Lumen Midline Catheter vs Ultrasound Guided Peripheral IV as Performed by Bedside Emergency Department Registered Nurses
Difficult Vein Access, Emergency Department Patients
Enrolling by invitation
Use of Hand Extension Rubber During Intravenous Catheter Placement
Pain, Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
BETÜL TOSUN, DOÇ. DR. principal investigator
Karamanoğlu Mehmetbey University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing I.V. House UltraDressing in people with Peripheral Catheterization and Complications, run by Karamanoğlu Mehmetbey University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PIVC Monitoring Form (time frame: up to 1 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.