NCT07437040

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 10, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2022

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

February 22, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

4 months

First QC Date

February 22, 2026

Last Update Submit

February 26, 2026

Conditions

Keywords

Medical Device-Related Pressure InjuryCentral Venous CatheterCatheter DressingPressure InjuryIntensive Care UnitBraden Scale

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Moisture at central venous catheter site

    Day 2, Day 9, and Day 16

  • Pressure injury risk (Braden Scale)

    Day 1, Day 2, Day 9, and Day 16

Study Arms (2)

Gauze and Adhesive Tape

EXPERIMENTAL

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

Device: Gauze Dressing

Chlorhexidine Gluconate Transparent Dressing

EXPERIMENTAL

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

Device: Chlorhexidine Gluconate Transparent Dressing

Interventions

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

Gauze and Adhesive Tape

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

Chlorhexidine Gluconate Transparent Dressing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prof. Dr. Cemil Taşçıoğlu City Hospital

Istanbul, Istanbul, 34384, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Hilal Uysal, PhD

    Bartın University, Department of Internal Medicine Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This study is a randomized, parallel-group interventional trial. Eligible participants were assigned to one of two groups using randomization. In one group, central venous catheter dressings were performed using gauze and adhesive tape, while in the other group, chlorhexidine gluconate-impregnated transparent dressings were used. Participants remained in their assigned group throughout the study without crossover. Pressure injury development and risk assessments were evaluated and compared at predefined observation time points.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Nurse, Cardiovascular Surgery Unit

Study Record Dates

First Submitted

February 22, 2026

First Posted

February 27, 2026

Study Start

August 10, 2022

Primary Completion

December 10, 2022

Study Completion

December 10, 2022

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

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.

Locations