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

NCT07855835 | Completed

• 1 other identifier: 2025/287
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

Central venous catheter; skin protective barrier film; skin integrity; dressing integrity; central line-associated bloodstream infection; intensive care

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline (T0) and Day 7 (T1)

Secondary Outcomes (5)

• Change in Skin Tear Status From Baseline to Day 7

  Baseline (T0) and Day 7 (T1)

• Change in Central Venous Catheter Dressing Integrity From Baseline to Day 7

  Baseline (T0) and Day 7 (T1)

• Change in Drainage at the Central Venous Catheter Insertion Site From Baseline to Day 7

  Baseline (T0) and Day 7 (T1)

• Change in Clinical Signs of Infection From Baseline to Day 7

  Baseline (T0) and Day 7 (T1)

• Occurrence of Central Line-Associated Bloodstream Infection During the 7-Day Follow-up

  From baseline through Day 7

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants received central venous catheter dressing care with the addition of a skin protective barrier film.

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

Other: Standard Central Venous Catheter Dressing Care

Interventions

Skin Protective Barrier Film DEVICE

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

Intervention Group

Standard Central Venous Catheter Dressing Care OTHER

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.

Control Group; Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bagcilar Training and Research Hospital

Istanbul, 34200, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 29576395 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, two-arm, parallel-group controlled trial."

Study Record Dates

• First Submitted: September 28, 2026
• First Posted: October 2, 2026
• Study Start: January 20, 2026
• Primary Completion: May 15, 2026
• Study Completion: May 15, 2026
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)