NewbornNCT05694390
The Effect of the Use of Sterile Transparent Film Dressing in Newborns
A study testing Use of sterile transparent film dressing in people with Newborn and Peripheral Venous Catheterization, run by Yuksek Ihtisas Hospital at 1 site in Turkey (Türkiye).
Trial summary
It is important that effective catheter fixation will reduce the risk of catheter unavailability for specific reasons and the incidence of catheter-related complications. The aim of this study was to determine the effect of sterile transparent film dressing and tape methods used in pe- ripheral intravenous catheter… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Newborn, Peripheral Venous Catheterization
- What is being tested?
- Use of sterile transparent film dressing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2019to 30 Sep 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- less than 4 kg (due to the infiltration scale criteria)
- PICV was inserted for the first time
Who cannot join
- existing catheter,
- who has a catheter other than PICV (PICC, umbilical catheter, etc.),
- sterile transparent film dressing, tape, babies with allergies to antiseptic solution and catheter,
- with immunodeficiency, and with skin problems that prevent catheter opening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of the Use of Sterile Transparent Film Dressing on the Duration of Catheter Stay and the Development of Catheter-Related Complications in Newborns
It is important that effective catheter fixation will reduce the risk of catheter unavailability for specific reasons and the incidence of catheter-related complications. The aim of this study was to determine the effect of sterile transparent film dressing and tape methods used in pe- ripheral intravenous catheter application in newborns on the duration of catheter stay and the development of catheter-related complications.
Read the detailed description
It has been reported that effective catheter fixation will reduce the risk of catheter unavailability for specific reasons and the incidence of catheter-related complications. Intravenous cannulas are usually fixed with a thin board, a bandage, and tape. There is no standard way of using PIVC dressings in Turkey. After the catheter is inserted into the vein, gauze and a blaster, sterile transparent dressing materials, or just a blaster, are used to prevent contact of the fixed part and the area of intervention with the external environment. Transparent dressing used for catheter fixation contribute to a more comfortable evaluation of the catheter entry site. It has been suggested that the use of transparent film dressing may be effective in preventing and early detection of catheter-related complications. Moreover, it was concluded that due to the short duration of the procedure, it reduced the cost of manpower, and nurses could devote more time to other patients.
- Conditions
- Newborn, Peripheral Venous Catheterization
- Being tested
- Use of sterile transparent film dressing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of sterile transparent film dressingOther
The nurses in the unit were trained by the charge nurse of the clinic on catheter-related complications (infiltration, extravasation, phlebitis, and occlusion), the scales used in the study, and the use of sterile transparent film dressing. In the experimental group, a sterile transparent film dressing was used to fix the catheter and was monitored hourly until the catheter was removed. The infiltration scale for infants, , the criteria of extravasation (Redness accompanied by a vesicle, tissue necrosis, and ulcer), and The Phlebitis Scale were used to evaluate the catheter site.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group: The group applied sterile transparent film dressing | Experimental | The nurses in the unit were trained by the charge nurse of the clinic on catheter-related complications (infiltration, extravasation, phlebitis, and occlusion), the scales used in the study, and the use of sterile transparent film dressing. In the experimental group, a sterile transparent film dressing was used to fix the catheter and was monitored hourly until the catheter was removed. Receives: Other: Use of sterile transparent film dressing |
| Control group: The group applied fixed with a tape (blaster) | No intervention | The nurses in the unit were trained by the charge nurse of the clinic on catheter-related complications (infiltration, extravasation, phlebitis, and occlusion), the scales used in the study, and the use of sterile transparent film dressing. In the control group, the catheter was fixed with a tape (blaster), routinely used in the clinic, and was monitored hourly until the catheter was removed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The infiltration scale for infants
The scale published by the Infusion Nurses Association was revised by Tofani et al. The adaptation of the scale to the newborns was carried out by Calikusu Incekar et al. The scale consists of 5 grades: 0, 1, 2, 3, 4 and is applied to babies under 4 kg. In this study, the infiltration scale was used to determine infiltration and extravasation. In addition to the scale items, the criteria of "Redness accompanied by a vesicle, tissue necrosis, and ulcer" were also considered based on the literature to determine extravasation.
Measured: during catheter removal procedure
The Phlebitis Scale
The phlebitis scale published by the Infusion Nurses Society was used. The scale consists of 5 grades: 0, 1, 2, 3, 4.
Measured: during catheter removal procedure
Occlusion
The nurse checked the infant's catheter site for occlusion.
Measured: during catheter removal procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2023
- Study start1 Feb 2019
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NewbornStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuksek Ihtisas Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mujde CALIKUSU Incekar, Yuksek Ihtisas Hospital
- Investigators
- Suzan YILDIZ, PhD, Principal investigator, Istanbul University - CerrahpasaYağmur GÜL, BSN, Principal investigator, Istanbul Florence Nightingale HospitalOzan UZUNHAN, MD, Principal investigator, Istanbul Florence Nightingale Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05694390
- Sponsor's protocol ID
- YIU-M-CI-004
- Status last verified
- Jan 2023
- First submitted
- 22 Dec 2022
- Last updated
- 23 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Use of Sterile Transparent Film Dressing on the Duration of Catheter Stay and the Development of Catheter-Related Complications in Newborns
- ClinicalTrials.gov ID
- NCT05694390
- Acronym / sponsor ID
- YIU-M-CI-004
- Conditions
- Newborn, Peripheral Venous Catheterization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Yuksek Ihtisas HospitalUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 23 Jan 2023 (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.
It is important that effective catheter fixation will reduce the risk of catheter unavailability for specific reasons and the incidence of catheter-related complications. The aim of this study was to determine the effect of sterile transparent film dressing and tape methods used in pe- ripheral intravenous catheter application in newborns on the duration of catheter stay and the development of catheter-related complications.
Detailed description
It has been reported that effective catheter fixation will reduce the risk of catheter unavailability for specific reasons and the incidence of catheter-related complications. Intravenous cannulas are usually fixed with a thin board, a bandage, and tape. There is no standard way of using PIVC dressings in Turkey. After the catheter is inserted into the vein, gauze and a blaster, sterile transparent dressing materials, or just a blaster, are used to prevent contact of the fixed part and the area of intervention with the external environment. Transparent dressing used for catheter fixation contribute to a more comfortable evaluation of the catheter entry site. It has been suggested that the use of transparent film dressing may be effective in preventing and early detection of catheter-related complications. Moreover, it was concluded that due to the short duration of the procedure, it reduced the cost of manpower, and nurses could devote more time to other patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group: The group applied sterile transparent film dressing | Experimental | Other: Use of sterile transparent film dressingThe nurses in the unit were trained by the charge nurse of the clinic on catheter-related complications (infiltration, extravasation, phlebitis, and occlusion), the scales used in the study, and the use of sterile transparent film dressing. In the experimental group, a sterile transparent film dressing was used to fix the catheter and was monitored hourly until the catheter was removed. |
| Control group: The group applied fixed with a tape (blaster) | No intervention | –The nurses in the unit were trained by the charge nurse of the clinic on catheter-related complications (infiltration, extravasation, phlebitis, and occlusion), the scales used in the study, and the use of sterile transparent film dressing. In the control group, the catheter was fixed with a tape (blaster), routinely used in the clinic, and was monitored hourly until the catheter was removed. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- less than 4 kg (due to the infiltration scale criteria)
- PICV was inserted for the first time
Key exclusion criteria (4 listed)
- existing catheter,
- who has a catheter other than PICV (PICC, umbilical catheter, etc.),
- sterile transparent film dressing, tape, babies with allergies to antiseptic solution and catheter,
- with immunodeficiency, and with skin problems that prevent catheter opening
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 |
|---|---|---|
| Use of sterile transparent film dressingThe nurses in the unit were trained by the charge nurse of the clinic on catheter-related complications (infiltration, extravasation, phlebitis, and occlusion), the scales used in the study, and the use of sterile transparent film dressing. In the experimental group, a sterile transparent film dressing was used to fix the catheter and was monitored hourly until the catheter was removed. The infiltration scale for infants, , the criteria of extravasation (Redness accompanied by a vesicle, tissue necrosis, and ulcer), and The Phlebitis Scale were used to evaluate the catheter site. | Other | Experimental group: The group applied sterile transparent film dressing |
Primary outcome
The infiltration scale for infants
Time frame: during catheter removal procedure
The scale published by the Infusion Nurses Association was revised by Tofani et al. The adaptation of the scale to the newborns was carried out by Calikusu Incekar et al. The scale consists of 5 grades: 0, 1, 2, 3, 4 and is applied to babies under 4 kg. In this study, the infiltration scale was used to determine infiltration and extravasation. In addition to the scale items, the criteria of "Redness accompanied by a vesicle, tissue necrosis, and ulcer" were also considered based on the literature to determine extravasation.
The Phlebitis Scale
Time frame: during catheter removal procedure
The phlebitis scale published by the Infusion Nurses Society was used. The scale consists of 5 grades: 0, 1, 2, 3, 4.
Occlusion
Time frame: during catheter removal procedure
The nurse checked the infant's catheter site for occlusion.
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 23 Jan 2023.
- Individual participant dataSharing planned: No
Related trials for Newborn
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
RecruitingPhase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Renal Failure Congenital, Congenital Renal Anomaly Nos
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
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.
Suzan YILDIZ, PhD principal investigator
Istanbul University - Cerrahpasa
Yağmur GÜL, BSN principal investigator
Istanbul Florence Nightingale Hospital
Ozan UZUNHAN, MD principal investigator
Istanbul Florence Nightingale Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of sterile transparent film dressing in people with Newborn and Peripheral Venous Catheterization, run by Yuksek Ihtisas Hospital 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 2 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 23 Jan 2023. 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?
The infiltration scale for infants (time frame: during catheter removal procedure). The study lists 3 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 23 Jan 2023.