Chlorhexidine Dressings for Hemodialysis Catheter Exit Site Care: Comparative Study

Hospital Universitario Marqués de Valdecilla

Status: Completed

Conditions: Hemodialysis Catheter Infection

Treatments: Device: Group "chlorhexidine dressing"; Other: Group "solution"

Study type: Interventional

Funder types: Other

Identifiers

NCT05855616

HUMV-PIE2020-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 53 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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53 participants in 2 patient groups

Group "chlorhexidine dressing"

Experimental group

Description:

CHG Chlorhexidine Gluconate dressing

Treatment:

Device: Group "chlorhexidine dressing"

Group "solution"

Other group

Description:

2% aqueous-based chlorhexidine solution and covering with a semi-permeable self-adhesive polyurethane dressing.

Treatment:

Other: Group "solution"