Chlorhexidine Dressings for Hemodialysis Catheter Exit Site Care: Comparative Study

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-01

Study Completion Date

2022-12-30

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.

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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.

Conditions

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Hemodialysis Catheter Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Group "chlorhexidine dressing"

CHG Chlorhexidine Gluconate dressing

Group Type EXPERIMENTAL

Group "chlorhexidine dressing"

Intervention Type 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"

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

Group Type OTHER

Group "solution"

Intervention Type 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.

Interventions

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Group "chlorhexidine dressing"

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.

Intervention Type DEVICE

Group "solution"

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.

Intervention Type OTHER

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.