Nurse's RoleNCT06310694
Additional Circular Dressing Material
A study testing intervention group (Elastane circular dressing on sterile transparent dressing) in people with Nurse's Role, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
The study was conducted to determine the effect of fixing peripheral intravenous catheter (PIVC) with additional circular dressing material on the duration of PIVC stay and complications related to peripheral intravenous catheterization. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nurse's Role
- What is being tested?
- intervention group (Elastane circular dressing on sterile transparent dressing)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Apr 2023to 30 Dec 2023
- 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
- Individuals between the ages of 18-65
- Literate individuals
- Individuals who can communicate and fully focus
- Individuals without vision, hearing or perception problems
Who cannot join
- Individuals hospitalized for less than 72 hours
- Individuals with edema degree 2 and above
- Individuals receiving Total Parenteral Nutrition, colloid, blood products
- Individuals with a BMI level of 29.9 and above (obese)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Fixing Peripheral Intravenous Catheter With Additional Circular Dressing Material Reduce PIVC Failure And Complications? A Randomized Controlled Trial
The study was conducted to determine the effect of fixing peripheral intravenous catheter (PIVC) with additional circular dressing material on the duration of PIVC stay and complications related to peripheral intravenous catheterization. In our study, a comparison was made of PIVCs applied to patients in the control (fixation of PIVC with a sterile transparent dressing) and intervention (fixation of PIVC with a sterile transparent dressing and application of an elastane circular dressing on it) groups in a public hospital in Turkey. All-cause PIVC failure was significantly higher in the intervention group (70.2%) compared to the control group (45.5%). It has been determined that fixing the PIVC with additional circular dressing material prolongs the duration of PIVC stay at the site.
Read the detailed description
This study was conducted as a randomized controlled study to determine the effect of fixing the peripheral intravenous catheter (PIVC) with additional circular dressing material on the duration of stay of the peripheral intravenous catheter and complications related to peripheral intravenous catheterization. In our study, a comparison was made of PIVCs applied to patients in the control (fixation of PIVC with a sterile transparent dressing) and intervention (fixation of PIVC with a sterile transparent dressing and application of an elastane circular dressing on it) groups in a public hospital in Turkey. In our study, PIVC failure was defined as PIVC removal before the end of treatment due to phlebitis, infiltration, accidental dislodgement, occlusion, and leakage. A total of 91 (47 intervention, 44 control) participants were included in the study between April 2023 and September 2023. All-cause PIVC failure was significantly higher in the intervention group (70.2%) compared to the control group (45.5%). It was determined that fixing the PIVC with additional circular dressing material prolongs the duration of PIVC stay at the site. It is recommended that this study be conducted with a different patient population and multicenter.
- Conditions
- Nurse's Role
- Being tested
- intervention group (Elastane circular dressing on sterile transparent dressing)
- Keywords
- peripheral cannulation, catheter related complications, infusions, intravenous, dressing, nursing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intervention group (Elastane circular dressing on sterile transparent dressing)Combination product
A circular dressing made of elastane material was placed on the patients in the intervention group on a sterile transparent dressing to provide additional fixation on the peripheral intravenous catheter.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group (Elastane circular dressing on sterile transparent dressing) | Experimental | A peripheral intravenous catheter was placed by following all the steps applied to the control group. A circular dressing made of elastane material was placed on the patients in the intervention group on a sterile transparent dressing to provide additional fixation on the peripheral intravenous catheter. There is no need to remove additional circular dressings during intravenous therapy.
The peripheral intravenous catheter was monitored for 72 hours with 8-hour observations. Peripheral intravenous catheter was evaluated for infiltration, phlebitis, pain, obstruction, dressing stability, and leakage. Receives: Combination Product: intervention group (Elastane circular dressing on sterile transparent dressing) |
| Control group (fixation of PIVC with a sterile transparent dressing) | No intervention | Peripheral intravenous catheter application was performed by the researcher in accordance with all steps. In the study, only patients who received a 20-gauge peripheral intravenous catheter were followed. The patient's peripheral intravenous catheter was fixed by the researcher with a sterile transparent dressing. The peripheral intravenous catheter was monitored for 72 hours with 8-hour observations. Peripheral intravenous catheter was evaluated for infiltration, phlebitis, pain, obstruction, dressing stability, and leakage. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin Penetration Difficulty Rating Scale
The Numerical Rating Scale was used by the investigator who performed the peripheral intravenous catheterization attempt to evaluate the severity of difficulty penetrating the skin. It is a scale with numbers from 1 to 10, with 1 (easy) on one end and 10 (very difficult) on the other end. After PIVC application, the difficulty of penetrating the skin during catheter insertion was evaluated by the researcher, scoring between 1 and 10.
Measured: four months
Visual Infusion Phlebitis Diagnostic Scale
Visual Infusion Phlebitis Diagnosis Scale includes grading steps and the symptoms of phlebitis seen at each stage in case of observation of the catheter for possible risks while applying treatment with a peripheral intravenous catheter or in case of phlebitis development. On this scale, symptoms of phlebitis such as redness, pain, swelling, fever and stiffness are rated from 1 to 5.
Measured: four months
Infiltration Rating Scale
The infiltration rating scale is used to determine the development and extent of infiltration. On the infiltration scale, infiltration development is graded between 0 and 4 points.
Measured: four months
Data Collection Form for the Patient Who Had a Peripheral Intravenous Catheter
In this form, information such as the patient's age, gender, weight, height, BMI (Body Mass Index), diagnosis, chronic disease, date and time of PIVC application, date and time of PIVC termination, reason for PIVC termination, and the region where PIVC was applied were recorded.
Measured: four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start27 Apr 2023
- Primary completion30 Sep 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nurse's RoleStudies 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
- Model description
- In our study, a comparison was made of PIVCs applied to patients in the control (fixation of PIVC with a sterile transparent dressing) and intervention (fixation of PIVC with a sterile transparent dressing and application of an elastane circular dressing on it) groups.
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şeyma Turan, Ege University
- Investigators
- Leyla Khorshid, Prof. Dr., Study director, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06310694
- Sponsor's protocol ID
- EGE-HEM-SL-01
- Status last verified
- Mar 2024
- First submitted
- 16 Feb 2024
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Fixing Peripheral Intravenous Catheter With Additional Circular Dressing Material Reduce PIVC Failure And Complications? A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06310694
- Acronym / sponsor ID
- EGE-HEM-SL-01
- Conditions
- Nurse's Role
- Keywords
- peripheral cannulation, catheter related complications, infusions, intravenous, dressing, nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 27 Apr 2023 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 15 Mar 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.
The study was conducted to determine the effect of fixing peripheral intravenous catheter (PIVC) with additional circular dressing material on the duration of PIVC stay and complications related to peripheral intravenous catheterization. In our study, a comparison was made of PIVCs applied to patients in the control (fixation of PIVC with a sterile transparent dressing) and intervention (fixation of PIVC with a sterile transparent dressing and application of an elastane circular dressing on it) groups in a public hospital in Turkey. All-cause PIVC failure was significantly higher in the intervention group (70.2%) compared to the control group (45.5%). It has been determined that fixing the PIVC with additional circular dressing material prolongs the duration of PIVC stay at the site.
Detailed description
This study was conducted as a randomized controlled study to determine the effect of fixing the peripheral intravenous catheter (PIVC) with additional circular dressing material on the duration of stay of the peripheral intravenous catheter and complications related to peripheral intravenous catheterization. In our study, a comparison was made of PIVCs applied to patients in the control (fixation of PIVC with a sterile transparent dressing) and intervention (fixation of PIVC with a sterile transparent dressing and application of an elastane circular dressing on it) groups in a public hospital in Turkey. In our study, PIVC failure was defined as PIVC removal before the end of treatment due to phlebitis, infiltration, accidental dislodgement, occlusion, and leakage. A total of 91 (47 intervention, 44 control) participants were included in the study between April 2023 and September 2023. All-cause PIVC failure was significantly higher in the intervention group (70.2%) compared to the control group (45.5%). It was determined that fixing the PIVC with additional circular dressing material prolongs the duration of PIVC stay at the site. It is recommended that this study be conducted with a different patient population and multicenter.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In our study, a comparison was made of PIVCs applied to patients in the control (fixation of PIVC with a sterile transparent dressing) and intervention (fixation of PIVC with a sterile transparent dressing and application of an elastane circular dressing on it) groups.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (Elastane circular dressing on sterile transparent dressing) | Experimental | Combination Product: intervention group (Elastane circular dressing on sterile transparent dressing)A peripheral intravenous catheter was placed by following all the steps applied to the control group. A circular dressing made of elastane material was placed on the patients in the intervention group on a sterile transparent dressing to provide additional fixation on the peripheral intravenous catheter. There is no need to remove additional circular dressings during intravenous therapy. The peripheral intravenous catheter was monitored for 72 hours with 8-hour observations. Peripheral intravenous catheter was evaluated for infiltration, phlebitis, pain, obstruction, dressing stability, and leakage. |
| Control group (fixation of PIVC with a sterile transparent dressing) | No intervention | –Peripheral intravenous catheter application was performed by the researcher in accordance with all steps. In the study, only patients who received a 20-gauge peripheral intravenous catheter were followed. The patient's peripheral intravenous catheter was fixed by the researcher with a sterile transparent dressing. The peripheral intravenous catheter was monitored for 72 hours with 8-hour observations. Peripheral intravenous catheter was evaluated for infiltration, phlebitis, pain, obstruction, dressing stability, and leakage. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Individuals between the ages of 18-65
- Literate individuals
- Individuals who can communicate and fully focus
- Individuals without vision, hearing or perception problems
Key exclusion criteria (4 listed)
- Individuals hospitalized for less than 72 hours
- Individuals with edema degree 2 and above
- Individuals receiving Total Parenteral Nutrition, colloid, blood products
- Individuals with a BMI level of 29.9 and above (obese)
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 |
|---|---|---|
| intervention group (Elastane circular dressing on sterile transparent dressing)A circular dressing made of elastane material was placed on the patients in the intervention group on a sterile transparent dressing to provide additional fixation on the peripheral intravenous catheter. | Combination product | Intervention Group (Elastane circular dressing on sterile transparent dressing) |
Primary outcome
Skin Penetration Difficulty Rating Scale
Time frame: four months
The Numerical Rating Scale was used by the investigator who performed the peripheral intravenous catheterization attempt to evaluate the severity of difficulty penetrating the skin. It is a scale with numbers from 1 to 10, with 1 (easy) on one end and 10 (very difficult) on the other end. After PIVC application, the difficulty of penetrating the skin during catheter insertion was evaluated by the researcher, scoring between 1 and 10.
Visual Infusion Phlebitis Diagnostic Scale
Time frame: four months
Visual Infusion Phlebitis Diagnosis Scale includes grading steps and the symptoms of phlebitis seen at each stage in case of observation of the catheter for possible risks while applying treatment with a peripheral intravenous catheter or in case of phlebitis development. On this scale, symptoms of phlebitis such as redness, pain, swelling, fever and stiffness are rated from 1 to 5.
Infiltration Rating Scale
Time frame: four months
The infiltration rating scale is used to determine the development and extent of infiltration. On the infiltration scale, infiltration development is graded between 0 and 4 points.
Data Collection Form for the Patient Who Had a Peripheral Intravenous Catheter
Time frame: four months
In this form, information such as the patient's age, gender, weight, height, BMI (Body Mass Index), diagnosis, chronic disease, date and time of PIVC application, date and time of PIVC termination, reason for PIVC termination, and the region where PIVC was applied were recorded.
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 15 Mar 2024.
Related trials for Nurse's Role
Not yet recruiting
The Effect of Creative Drama on the Therapeutic Communication Skills and Empathy Levels of Pediatric Nursing Students: A Randomized Controlled Study
Nurse's Role, Empathy
Active, not recruiting
Advancing Nursing Practices in Hospital Oncology Care
Gastrointestinal Cancer, Gastrointestinal Disease
RecruitingPhase 1
Two Different Therapeutic Interventions Applied During Blood Sampling in Children
Blood Sampling, Child, Only
Recruiting
Single Lumen Midline Catheter vs Ultrasound Guided Peripheral IV as Performed by Bedside Emergency Department Registered Nurses
Difficult Vein Access, Emergency Department Patients
Not yet recruitingObservational study
Research-patientS and Clinical researcH Nurses: Exploring Their Experiences of tAking paRt in Clinical resEarch in the NHS
Experiences, Lived Experiences
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.
Leyla Khorshid, Prof. Dr. study director
Ege 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 intervention group (Elastane circular dressing on sterile transparent dressing) in people with Nurse's Role, run by Ege 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 4 inclusion and 4 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 15 Mar 2024. 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?
Skin Penetration Difficulty Rating Scale (time frame: four months). The study lists 4 primary outcomes in all. 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 15 Mar 2024.