Chlorhexidine Dressings for Hemodialysis Catheter Exit Site Care: Comparative Study

Hemodialysis Catheter Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05855616
• Other study ID #: HUMV-PIE2020-02
• Status: Completed
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: December 30, 2022

Study information

• Verified date: January 2024
• Source: Hospital Universitario Marqués de Valdecilla
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: December 30, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hemodialysis Catheter Infection

Intervention

Device:
• 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.

Other:
• 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.

Locations

Country	Name	City	State
Spain	Raquel Pelayo Alonso	Santander	Cantabria

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Marqués de Valdecilla

Country where clinical trial is conducted

Spain, 

References & Publications (4)

Righetti M, Palmieri N, Bracchi O, Prencipe M, Bruschetta E, Colombo F, Brenna I, Stefani F, Amar K, Scalia A, Conte F. Tegaderm CHG dressing significantly improves catheter-related infection rate in hemodialysis patients. J Vasc Access. 2016 Sep 21;17(5):417-422. doi: 10.5301/jva.5000596. Epub 2016 Aug 1. — View Citation

Vanholder R, Canaud B, Fluck R, Jadoul M, Labriola L, Marti-Monros A, Tordoir J, Van Biesen W. Diagnosis, prevention and treatment of haemodialysis catheter-related bloodstream infections (CRBSI): a position statement of European Renal Best Practice (ERBP). NDT Plus. 2010 Jun;3(3):234-246. doi: 10.1093/ndtplus/sfq041. No abstract available. — View Citation

Wang K, Wang P, Liang X, Lu X, Liu Z. Epidemiology of haemodialysis catheter complications: a survey of 865 dialysis patients from 14 haemodialysis centres in Henan province in China. BMJ Open. 2015 Nov 20;5(11):e007136. doi: 10.1136/bmjopen-2014-007136. — View Citation

Wei L, Li Y, Li X, Bian L, Wen Z, Li M. Chlorhexidine-impregnated dressing for the prophylaxis of central venous catheter-related complications: a systematic review and meta-analysis. BMC Infect Dis. 2019 May 16;19(1):429. doi: 10.1186/s12879-019-4029-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bacteraemia Rate	presence of fever (body temperature =38°C) together with a positive blood culture , with no other source of infection.	3 months
Primary	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
Primary	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	Patient Satisfaction Rate	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.	3 months
Secondary	Percentage of Hemodialysis Sessions With Skin Lesions	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 months
Secondary	Percentage of Hemodialysis Sessions With Dressing-related Skin Erythema Rate	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.	3 months