Chlorhexidine Dressings for Hemodialysis Catheter Exit Site Care: Comparative Study

Not Applicable

Completed

Interventions: Other: Group "solution"
Device: Group "chlorhexidine dressing"

Brief Summary: 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: 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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Group "solution"	Group "solution"	2% aqueous-based chlorhexidine solution and covering with a semi-permeable self-adhesive polyurethane dressing.
Group "chlorhexidine dressing"	Group "chlorhexidine dressing"	CHG Chlorhexidine Gluconate dressing

Primary Outcome Measures

Name	Time	Method
Bacteraemia Rate	3 months	presence of fever (body temperature ≥38°C) together with a positive blood culture , with no other source of infection.
Tunnelitis Rate	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.
Exit Site Infection Rate	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.

Secondary Outcome Measures

Name	Time	Method
Patient Satisfaction Rate	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.
Percentage of Hemodialysis Sessions With Skin Lesions	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.
Percentage of Hemodialysis Sessions With Dressing-related Skin Erythema Rate	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.