Central Venous Catheter CareNCT07855835

SKİN PROTECTİVE BARRİER FİLM İN CENTRAL VENOUS CATHETER CARE İN INTENSİVE CARE PATİENTS

A study testing Skin Protective Barrier Film and Standard Central Venous Catheter Dressing Care in people with Central Venous Catheter Care, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Central Venous Catheter Care
What is being tested?: Skin Protective Barrier Film and Standard Central Venous Catheter Dressing Care
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 72 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 20 Jan 2026to 15 May 2026
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 18 years or older
Admitted to the intensive care unit and requiring a central venous catheter
Expected to be followed with a central venous catheter for 7 to 10 days
No infection at the time of enrollment
Not receiving immunosuppressive therapy
No known allergy to chlorhexidine gluconate or povidone-iodine
Not pregnant
Written informed consent provided by the participant or the participant's legally authorized representative

Who cannot join

Central venous catheter follow-up for less than 7 days
Presence of infection at the time of enrollment
Receiving immunosuppressive therapy
Known allergy to chlorhexidine gluconate or povidone-iodine
Pregnancy

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Bagcilar Training and Research Hospital
Istanbul, 34200

Other trials in Turkey (Türkiye)

About this study

Official title: THE EFFECTIVENESS OF SKIN PROTECTIVE BARRIER FILM USE IN CENTRAL VENOUS CATHETER CARE OF INTENSIVE CARE PATIENTS: A RANDOMİZED CONTROLLED TRİAL

This randomized controlled study evaluated the effectiveness of a skin protective barrier film used during central venous catheter (CVC) care in adult intensive care unit patients. A total of 72 patients with a CVC were randomly assigned in a 1:1 ratio to an intervention group or a control group. In the intervention group, a skin protective barrier film was applied during CVC dressing care in addition to the standard care procedure. The control group received standard CVC dressing care without the skin protective barrier film. Patients were followed for seven days. Dressing integrity, skin integrity at the catheter insertion site, presence and type of drainage, signs of infection, and central line-associated bloodstream infection were evaluated. The study aimed to determine whether the use of a skin protective barrier film during CVC care contributes to maintaining skin and dressing integrity and affects catheter-related complications.

Conditions: Central Venous Catheter Care
Being tested: Skin Protective Barrier Film, Standard Central Venous Catheter Dressing Care
Keywords: Central venous catheter, skin protective barrier film, skin integrity, dressing integrity, central line-associated bloodstream infection, intensive care

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Skin Protective Barrier FilmDevice
A skin protective barrier film was applied to the central venous catheter dressing area during catheter care before placement of the transparent dressing. The intervention was used in addition to standard central venous catheter care
Standard Central Venous Catheter Dressing CareOther
Participants received standard central venous catheter dressing care without the use of a skin protective barrier film. The catheter insertion site was cleaned with a chlorhexidine gluconate-containing antiseptic solution using sterile gauze, allowed to dry, and then covered with a chlorhexidine gluconate-containing transparent dressing.

Study groups in NCT07855835
Study group	Role	What they receive
Intervention Group	Experimental	Participants received central venous catheter dressing care with the addition of a skin protective barrier film. Receives: Device: Skin Protective Barrier Film; Other: Standard Central Venous Catheter Dressing Care
Control Group	Active comparator	Participants received standard central venous catheter dressing care without the skin protective barrier film Receives: Other: Standard Central Venous Catheter Dressing Care

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Central Venous Catheter Insertion-Site Skin Integrity From Baseline to Day 7
Skin integrity at the central venous catheter insertion site was assessed at baseline and after 7 days. Skin condition was categorized as normal, hyperemia, irritation, adhesive residue, or moisture/leakage under the dressing
Measured: Baseline (T0) and Day 7 (T1)

Secondary outcomes (5)

Change in Skin Tear Status From Baseline to Day 7
Skin tear status was assessed using the International Skin Tear Advisory Panel (ISTAP) Classification System. Skin tears were classified as Type 1 (no skin loss), Type 2 (partial skin loss), or Type 3 (total skin loss)
Measured: Baseline (T0) and Day 7 (T1)
Change in Central Venous Catheter Dressing Integrity From Baseline to Day 7
Central venous catheter dressing integrity was assessed at baseline and after 7 days. Dressing integrity was categorized as intact or partially disrupted
Measured: Baseline (T0) and Day 7 (T1)
Change in Drainage at the Central Venous Catheter Insertion Site From Baseline to Day 7
Drainage at the central venous catheter insertion site was assessed for presence and type. Drainage was categorized as absent, serous, purulent, or hemorrhagic
Measured: Baseline (T0) and Day 7 (T1)
Change in Clinical Signs of Infection From Baseline to Day 7
Clinical signs of infection were assessed at baseline and after 7 days. The assessed signs included redness, tenderness, and fever, with each sign recorded as present or absent
Measured: Baseline (T0) and Day 7 (T1)
Occurrence of Central Line-Associated Bloodstream Infection During the 7-Day Follow-up
The occurrence of central line-associated bloodstream infection (CLABSI) during the 7-day follow-up period was recorded as present or absent based on surveillance data from the hospital Infection Control Committee
Measured: From baseline through Day 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Jan 202615 May 2026

First posted2 Oct 2026
Study start20 Jan 2026
Primary completion15 May 2026
Study completion15 May 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Central Venous Catheter CareStudies of the same condition, open and under way.
More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: Randomized, two-arm, parallel-group controlled trial."
Masking: None (open label)
Enrolment: 72 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07855835
Sponsor's protocol ID: 2025/287
Status last verified: Sep 2026
First submitted: 28 Sep 2026
Last updated: 2 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Pivkina AI, Gusarov VG, Blot SI, Zhivotneva IV, Pasko NV, Zamyatin MN. Effect of an acrylic terpolymer barrier film beneath transparent catheter dressings on skin integrity, risk of dressing disruption, catheter colonisation and infection. Intensive Crit Care Nurs. 2018 Jun;46:17-23. doi: 10.1016/j.iccn.2017.11.002. Epub 2018 Mar 23.
PubMed 29576395

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Evaluation of an AI-Assisted Tool for CLABSI Surveillance at VA Medical Centers
Central Line-Associated Bloodstream Infection (CLABSI), Bacteremia
Recruiting
Prophylactic Anticoagulation for Central Venous Line Insertion in Critically Ill Children
Prophylactic, Anticoagulation
RecruitingPhase 4
Open-Label Study to Assess Safety and Time to Catheter-related Bloodstream Infections (CRBSI) in Subjects From Birth to < 18 Years of Age
Catheter-Related Infections
Not yet recruitingObservational study
Efficacy and Safety of Peripherally Inserted Central Venous Catheters
Critical Illness, Catheter-Related Infections
Not yet recruiting
Comparison of the Best Method for Measuring Anti-Xa Activity in Children Receiving Unfractionated Heparin in Cardiac Intensive Care (COMPAXE-HNF)
Congenital Heart Disease, Unfractionated Heparin

All Central Venous Catheter Care trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: THE EFFECTIVENESS OF SKIN PROTECTIVE BARRIER FILM USE IN CENTRAL VENOUS CATHETER CARE OF INTENSIVE CARE PATIENTS: A RANDOMİZED CONTROLLED TRİAL
ClinicalTrials.gov ID: NCT07855835
Acronym / sponsor ID: 2025/287
Conditions: Central Venous Catheter Care
Keywords: Central venous catheter, skin protective barrier film, skin integrity, dressing integrity, central line-associated bloodstream infection, intensive care
Study type: Interventional
Recruitment status: Completed
Enrolment: 72 participants (actual)
Lead sponsor: Bezmialem Vakif UniversityUniversity, hospital or other
Study start: 20 Jan 2026 (actual)
Primary completion: 15 May 2026 (actual)
Study completion: 15 May 2026 (actual)
First posted: 2 Oct 2026 (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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Randomized, two-arm, parallel-group controlled trial."

Arm	Type	Receives
Intervention Group	Experimental	Device: Skin Protective Barrier Film, Other: Standard Central Venous Catheter Dressing CareParticipants received central venous catheter dressing care with the addition of a skin protective barrier film.
Control Group	Active comparator	Other: Standard Central Venous Catheter Dressing CareParticipants received standard central venous catheter dressing care without the skin protective barrier film

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Age 18 years or older
Admitted to the intensive care unit and requiring a central venous catheter
Expected to be followed with a central venous catheter for 7 to 10 days
No infection at the time of enrollment
Not receiving immunosuppressive therapy

Key exclusion criteria (5 listed)

Central venous catheter follow-up for less than 7 days
Presence of infection at the time of enrollment
Receiving immunosuppressive therapy
Known allergy to chlorhexidine gluconate or povidone-iodine
Pregnancy

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
Skin Protective Barrier FilmA skin protective barrier film was applied to the central venous catheter dressing area during catheter care before placement of the transparent dressing. The intervention was used in addition to standard central venous catheter care	Device	Intervention Group
Standard Central Venous Catheter Dressing CareParticipants received standard central venous catheter dressing care without the use of a skin protective barrier film. The catheter insertion site was cleaned with a chlorhexidine gluconate-containing antiseptic solution using sterile gauze, allowed to dry, and then covered with a chlorhexidine gluconate-containing transparent dressing.	Other	Control Group, Intervention Group

Primary outcome

Change in Central Venous Catheter Insertion-Site Skin Integrity From Baseline to Day 7
Time frame: Baseline (T0) and Day 7 (T1)
Skin integrity at the central venous catheter insertion site was assessed at baseline and after 7 days. Skin condition was categorized as normal, hyperemia, irritation, adhesive residue, or moisture/leakage under the dressing

5 secondary outcomes

Change in Skin Tear Status From Baseline to Day 7
Time frame: Baseline (T0) and Day 7 (T1)
Change in Central Venous Catheter Dressing Integrity From Baseline to Day 7
Time frame: Baseline (T0) and Day 7 (T1)
Change in Drainage at the Central Venous Catheter Insertion Site From Baseline to Day 7
Time frame: Baseline (T0) and Day 7 (T1)
Change in Clinical Signs of Infection From Baseline to Day 7
Time frame: Baseline (T0) and Day 7 (T1)
Occurrence of Central Line-Associated Bloodstream Infection During the 7-Day Follow-up
Time frame: From baseline through Day 7

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 2 Oct 2026.
Background: PubMed 29576395Pivkina AI, Gusarov VG, Blot SI, Zhivotneva IV, Pasko NV, Zamyatin MN. Effect of an acrylic terpolymer barrier film beneath transparent catheter dressings on skin integrity, risk of dressing disruption, catheter colonisation and infection. Intensive Crit Care Nurs. 2018 Jun;46:17-23. doi: 10.1016/j.iccn.2017.11.002. Epub 2018 Mar 23.
Individual participant dataSharing planned: No

Related trials for Central Venous Catheter Care

Not yet recruiting
Evaluation of an AI-Assisted Tool for CLABSI Surveillance at VA Medical Centers
Central Line-Associated Bloodstream Infection (CLABSI), Bacteremia
Recruiting
Prophylactic Anticoagulation for Central Venous Line Insertion in Critically Ill Children
Prophylactic, Anticoagulation
RecruitingPhase 4
Open-Label Study to Assess Safety and Time to Catheter-related Bloodstream Infections (CRBSI) in Subjects From Birth to < 18 Years of Age
Catheter-Related Infections
Not yet recruitingObservational study
Efficacy and Safety of Peripherally Inserted Central Venous Catheters
Critical Illness, Catheter-Related Infections
Not yet recruiting
Comparison of the Best Method for Measuring Anti-Xa Activity in Children Receiving Unfractionated Heparin in Cardiac Intensive Care (COMPAXE-HNF)
Congenital Heart Disease, Unfractionated Heparin

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 8 inclusion and 5 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 2 Oct 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?

Change in Central Venous Catheter Insertion-Site Skin Integrity From Baseline to Day 7 (time frame: Baseline (T0) and Day 7 (T1)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07855835, which also lists 1 linked publication.

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 2 Oct 2026.