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

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Status: Completed

Conditions: Medical Device Related Pressure Ulcer (MDRPU); Pressure Injuries

Treatments: Device: Chlorhexidine Gluconate Transparent Dressing; Device: Gauze Dressing

Study type: Interventional

Funder types: Other

Identifiers

NCT07437040

E-74555795-050.01.04-391967

Details and patient eligibility

About

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.

Full 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.

Enrollment: 78 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

78 participants in 2 patient groups

Gauze and Adhesive Tape

Experimental group

Description:

Participants received central venous catheter dressing using gauze and adhesive tape according to institutional protocol.

Treatment:

Device: Gauze Dressing

Chlorhexidine Gluconate Transparent Dressing

Experimental group

Description:

Participants received central venous catheter dressing using chlorhexidine gluconate-impregnated transparent dressing according to institutional protocol.

Treatment:

Device: Chlorhexidine Gluconate Transparent Dressing