Chlorhexidine Dressings for Hemodialysis Catheter Exit Site Care: Comparative Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Hemodialysis Catheter Infection

Intervention / Treatment
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* Device: Group chlorhexidine dressing
* Other: Group solution


Participation Criteria
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Eligibility Criteria
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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. Active catheter-related infection.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Group A: Haemodialysis catheter exit site dressing with 2% chlorhexidine gluconate self-adhesive semi-permeable polyurethane dressings Group B: Haemodialysis catheter exit site dressing with 2% chlorhexidine aqueous solution and covered with a dressing of self-adhesive semi-permeable polyurethane dressings.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group chlorhexidine dressing<br>CHG Chlorhexidine Gluconate dressing | Device: Group chlorhexidine dressing<br>* 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.<br>|
| Other: Group solution<br>2% aqueous-based chlorhexidine solution and covering with a semi-permeable self-adhesive polyurethane dressing. | Other: Group solution<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacteraemia rate | presence of fever (body temperature ≥38°C) together with a positive blood culture , with no other source of infection. | 3 months | 
| Exit site infection rate | 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 months | 
| Tunnelitis rate | 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. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction rate | SCALE 18 Degree of perception of positive expectations, of the NOC taxonomy (5-point Likert-type scale where 1- Not at all satisfied, 2- Somewhat satisfied, 3- Moderately satisfied, 4- Very satisfied, 5- Completely satisfied) will be used. | 3 months | 
| Dressing-related skin alterations rate | be assessed at each haemodialysis session, using the NOC taxonomy: [110115] Skin lesions o SCALE 14 Degree of a negative or adverse state or response: -Serious - Substantial - Moderate - Mild - None | 3 months | 
| Dressing-related skin alterations rate | be assessed at each haemodialysis session, using the NOC taxonomy: [110121] Erythema o SCALE 14 Degree of a negative or adverse state or response: Serious - Substantial - Moderate - Mild - None | 3 months |