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

February 26, 2026 updated by: Ciler Onay, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
78

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Medical device-related pressure injury at central venous catheter site.
Time Frame: Day 2, Day 9, and Day 16
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Moisture at central venous catheter site
Time Frame: Day 2, Day 9, and Day 16
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)
Time Frame: Day 1, Day 2, Day 9, and Day 16
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hilal Uysal, PhD, Bartın University, Department of Internal Medicine Nursing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 10, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 10, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 10, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 22, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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