Clinical trial NCT05855616: Chlorhexidine Dressings for Hemodialysis Catheter Exit Site Care: Comparative Study
Official title: Comparative Study of Two Haemodialysis Catheter Exit Site Dressings: Chlorhexidine Gluconate Dressing vs Chlorhexidine 2% Solution.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodialysis Catheter Infection
Lead sponsor: Hospital Universitario Marqués de Valdecilla
Sponsor class: OTHER
First posted: 2023-05-11
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Bacteraemia Rate
timeFrame: 3 months
measure: Exit Site Infection Rate
timeFrame: 3 months
measure: Tunnelitis Rate
timeFrame: 3 months
Secondary outcomes:
measure: Patient Satisfaction Rate
timeFrame: 3 months
measure: Percentage of Hemodialysis Sessions With Skin Lesions
timeFrame: 3 months
measure: Percentage of Hemodialysis Sessions With Dressing-related Skin Erythema Rate
timeFrame: 3 months
Other outcomes:
Locations:
city: Santander
country: Spain
facility: Raquel Pelayo Alonso
state: Cantabria
Study officials:
References:
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.
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.
citation: 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.
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.