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NCT Number: NCT05855616

Chlorhexidine Dressings for Hemodialysis Catheter Exit Site Care: Comparative Study

The objective of this study is to compare the rate of hemodialysis catheter-related infections according to the treatment regimen: chlorhexidine gluconate dressing or chlorhexidine solution.

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Key information

Conditions

Hemodialysis Catheter Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Raquel Pelayo Alonso

Santander, Cantabria, 39008, Spain

About this study

Introduction: The use of CVC as a vascular access for haemodialysis is associated with increased morbidity and mortality (up to 10 times higher in a patient with a CVC compared to an arteriovenous fistula), contributing to poorer patient outcomes and increased haemodialysis-related costs.

Aim: To compare the rate of catheter-related infections (bacteraemia, exit site infection and tunelitis) between haemodialysis catheter exit site dressing with 2% chlorhexidine gluconate self-adhesive semi-permeable polyurethane dressings (AGCD); and dressing with 2% chlorhexidine solution and covered with self-adhesive semi-permeable polyurethane dressing (PD).

Methods: A randomized clinical trial will be conducted to compare the occurrence of local and systemic infections related to hemodialysis catheter. Two care groups will be formed in which AGCD and PD dressings will be used. In addition, other clinical variables, patient satisfaction and dressing-related skin alterations will also be analyzed.

Scientific relevance: Infectious complications related with hemodialysis catheter have an increased morbidity, mortality and incremented costs.

Key words: hemodialysis, Central Venous Catheters, Bacteremia, exit site infection, tunnel infection, chlorhexidine gluconate dressing.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Be included in the haemodialysis programme in our unit.
  • Being a carrier of a tunneled central venous catheter as vascular access.
  • Remain on haemodialysis treatment for at least 3 months in our unit.
  • Consent to participate in the study.

Exclusion criteria

  • Allergy or hypersensitivity to chlorhexidine or intolerance to polyurethane dressing
  • Active catheter-related infection.

Treatment and study plan

Group "chlorhexidine dressing"

Device

Cleaning of the exit site with physiological saline (0.9%), drying with sterile gauze, application of semi-permeable polyurethane dressing with self-adhesive 2% chlorhexidine gluconate, centring the chlorhexidine gluconate band well over the exit site.

Group "solution"

Other

Cleansing of the exit site with physiological saline (0.9%), drying with sterile gauze, disinfection with 2% aqueous-based chlorhexidine solution, environmental drying for 30 seconds and covering with a semi-permeable self-adhesive polyurethane dressing.

Primary outcomes

  1. Bacteraemia Rate

    Time frame: 3 months

    presence of fever (body temperature ≥38°C) together with a positive blood culture , with no other source of infection.

  2. Exit Site Infection Rate

    Time frame: 3 months

    positive culture of pericatheter smear together with presence of inflammatory signs limited to 2 cm around the cutaneous exit site, without upper extension towards the catheter cuff.

  3. Tunnelitis Rate

    Time frame: 3 months

    occurrence of inflammatory signs extending beyond 2 cm from the cutaneous exit site and into the subcutaneous tract of the catheter (tunnelitis). It may or may not be associated with fever and bacteraemia, and may be accompanied by purulent exudate through the cutaneous exit site.

Secondary outcomes

  1. Patient Satisfaction Rate

    Time frame: 3 months

    SCALE 18: Degree of perception of positive expectations, of the NOC taxonomy will be used.

    It will be evaluated using a 5-point Likert-type scale where 1- Not at all satisfied, 2- Somewhat satisfied, 3- Moderately satisfied, 4- Very satisfied, 5- Completely satisfied.

  2. Percentage of Hemodialysis Sessions With Skin Lesions

    Time frame: 3 months

    They will be assessed at each hemodialysis session, using the NOC taxonomy Skin lesions, by means of the SCALE 14: Degree of a negative or adverse condition or response.

    A 5-point Likert-type scale will be used, where 1-Severe, 2-Substantial, 3-Moderate, 4-Leve, 5- None.

  3. Percentage of Hemodialysis Sessions With Dressing-related Skin Erythema Rate

    Time frame: 3 months

    They will be assessed at each hemodialysis session, using the NOC taxonomy Erytema, by means of the SCALE 14: Degree of a negative or adverse condition or response.

    A 5-point Likert-type scale will be used, where 1-Severe, 2-Substantial, 3-Moderate, 4-Leve, 5- None.

Sponsors and collaborators

Lead sponsor

Hospital Universitario Marqués de Valdecilla

Other

Registry information

Official study title

Comparative Study of Two Haemodialysis Catheter Exit Site Dressings: Chlorhexidine Gluconate Dressing vs Chlorhexidine 2% Solution.

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
May 11, 2023
Registry last updated
Feb 7, 2024

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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