Effect of Central Venous Catheter Dressing Types on Device-Related Pressure Injuries (CVC PROTECT)

The Effect of Central Venous Catheter Dressing Types on Medical Device-Related Pressure Injuries in Intensive Care Patients: A Randomized Controlled Trial

The purpose of this clinical trial is to evaluate the effect of different central venous catheter dressing methods on the development of medical device-related pressure injuries in participants treated in the intensive care unit.

This study aims to answer the following questions:

• What is the risk of pressure injury development in participants whose catheter dressings are performed using gauze and adhesive tape?
• What is the risk of pressure injury development in participants whose catheter dressings are performed using a chlorhexidine gluconate-containing transparent dressing?
• Is there a difference between these two dressing methods in terms of pressure injury development?

The researchers will compare participants receiving gauze and adhesive tape dressings with participants receiving chlorhexidine gluconate-containing transparent dressings.

Participants will:

• Receive catheter dressings according to the assigned dressing method based on randomization.
• Undergo regular catheter site assessments.
• Be evaluated for pressure injury development through skin assessments.
• Have their pressure injury risk monitored using the Braden Pressure Injury Risk Assessment Scale.

Study Overview

• Status: Completed
• Conditions: Pressure Injuries; Medical Device Related Pressure Ulcer (MDRPU)
• Intervention / Treatment: Device: Gauze Dressing; Device: Chlorhexidine Gluconate Transparent Dressing

Detailed Description

This study is a randomized controlled experimental study designed to evaluate the effects of different central venous catheter dressing methods on the development of medical device-related pressure injuries in participants treated in the intensive care unit.

The study was conducted in the intensive care unit of a tertiary-level hospital. Participants who underwent central venous catheterization and met the study protocol criteria were included.

Participants were assigned to two groups using a randomization method. The randomization process was performed to ensure balanced group distribution and to minimize potential bias.

In the first group, central venous catheter dressing was performed using gauze and adhesive tape. In the second group, dressing was performed using a chlorhexidine gluconate-containing transparent dressing.

Participants' catheter sites were systematically assessed at predetermined observation time points. During these assessments, skin integrity, skin surface characteristics, and clinical findings related to medical device-related pressure injury development were evaluated.

Catheter site evaluations were recorded using a structured observation form. Moisture at the catheter site and skin surface characteristics were assessed during routine follow-up.

Participants' pressure injury risk levels were evaluated using the Braden Pressure Injury Risk Assessment Scale.

Throughout the study, central venous catheter care and dressing procedures were performed in accordance with clinical protocols.

Data obtained during the study were analyzed using appropriate statistical methods.

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Istanbul
    • Istanbul, Istanbul, Turkey (Türkiye), 34384
      • Prof. Dr. Cemil Taşcıoğlu City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria: Patients hospitalized in the intensive care unit who:

• Were aged 18 years or older,
• Underwent a new central venous catheter insertion,
• Had no pressure injury at the catheter insertion site at baseline,
• Provided informed consent (patient or legal representative).

Exclusion Criteria: Patients who:

• Had a pressure injury at the catheter insertion site at baseline,
• Had dermatological conditions affecting skin integrity at the catheter site,
• Had a central venous catheter inserted at another institution,
• Were discharged or deceased before completion of follow-up.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gauze and Adhesive Tape; Participants received central venous catheter dressing using gauze and adhesive tape according to institutional protocol.	Device: Gauze Dressing; Central venous catheter dressing performed using sterile gauze and adhesive tape.
Experimental: Chlorhexidine Gluconate Transparent Dressing; Participants received central venous catheter dressing using chlorhexidine gluconate-impregnated transparent dressing according to institutional protocol.	Device: Chlorhexidine Gluconate Transparent Dressing; Central venous catheter dressing performed using chlorhexidine gluconate-impregnated transparent dressing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medical device-related pressure injury at central venous catheter site.	Incidence of Stage 1 medical device-related pressure injury at the central venous catheter insertion site, assessed according to the National Pressure Injury Advisory Panel (NPIAP) Staging System (Stage 1 represents non-blanchable erythema of intact skin; higher stages indicate greater tissue damage).	Day 2, Day 9, and Day 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Moisture at central venous catheter site	Assessment of moisture status at the central venous catheter insertion site during dressing changes.	Day 2, Day 9, and Day 16
Pressure injury risk (Braden Scale)	Pressure injury risk assessed using the Braden Scale for Predicting Pressure Sore Risk (total score range: 6-23; lower scores indicate higher risk of pressure injury).	Day 1, Day 2, Day 9, and Day 16

Collaborators and Investigators

• Sponsor: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
• Investigators: Principal Investigator: Hilal Uysal, PhD, Bartın University, Department of Internal Medicine Nursing

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2022
• Primary Completion (Actual): December 10, 2022
• Study Completion (Actual): December 10, 2022

Study Registration Dates

• First Submitted: February 22, 2026
• First Submitted That Met QC Criteria: February 22, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 26, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Intensive Care Unit; Central Venous Catheter; Pressure Injury; Medical Device-Related Pressure Injury; Catheter Dressing; Braden Scale
• Additional Relevant MeSH Terms: Skin Diseases; Skin Ulcer; Skin and Connective Tissue Diseases; Pressure Ulcer
• Other Study ID Numbers: E-74555795-050.01.04-391967

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared due to ethical and privacy considerations. The study data contain potentially identifiable clinical information, and data sharing is restricted by institutional and ethics committee policies.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No