Chlorhexidine Dressings for Hemodialysis Catheter Exit Site Care: Comparative Study

NCT05855616 | Completed Results FDA Device

• 1 other identifier: HUMV-PIE2020-02
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodialysis Catheter Infection

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Patient Satisfaction Rate

  3 months

• Percentage of Hemodialysis Sessions With Skin Lesions

  3 months

• Percentage of Hemodialysis Sessions With Dressing-related Skin Erythema Rate

  3 months

Study Arms (2)

Group "chlorhexidine dressing"

EXPERIMENTAL

CHG Chlorhexidine Gluconate dressing

Device: Group "chlorhexidine dressing"

Group "solution"

OTHER

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

Other: Group "solution"

Interventions

Group "chlorhexidine dressing" 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 "chlorhexidine dressing"

Group "solution" 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.

Group "solution"

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Universitario Marqués de Valdecilla: lead

Study Sites (1)

Raquel Pelayo Alonso

Santander, Cantabria, 39008, Spain

Location

Related Publications (4)

• 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.

  PMID: 30792802 BACKGROUND

• 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.

  PMID: 26589425 BACKGROUND

• 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.

  PMID: 27516139 BACKGROUND

• 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.

  PMID: 31096918 BACKGROUND

Limitations and Caveats

The main limitation is the limited follow-up time

Results Point of Contact

• Title: Raquel Pelayo Alonso, Head Nurse of Nephrology, RN
• Organization: Marques de Valdecilla University Hospital

raquel.pelayo@scsalud.es

+34 649443488

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head nurse of the Nephrology department, RN.

Model Details: 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.

Study Record Dates

• First Submitted: February 9, 2023
• First Posted: May 11, 2023
• Study Start: November 1, 2020
• Primary Completion: July 1, 2022
• Study Completion: December 30, 2022
• Last Updated: February 7, 2024
• Results First Posted: February 7, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)