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NCT Number: NCT07437040

Effect of Central Venous Catheter Dressing Types on Device-Related Pressure Injuries

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.

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Key information

Conditions

Pressure Injuries Medical Device Related Pressure Ulcer (MDRPU) Pressure Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prof. Dr. Cemil Taşçıoğlu City Hospital

Istanbul, 34384, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gauze dressing

Device

Central venous catheter dressing performed using sterile gauze and adhesive tape.

Chlorhexidine Gluconate Transparent Dressing

Device

Central venous catheter dressing performed using chlorhexidine gluconate-impregnated transparent dressing.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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).

Sponsors and collaborators

Lead sponsor

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Other

Registry information

Official study title

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

Acronym: CVC PROTECT

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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