Chlorhexidine Dressings for Hemodialysis Catheter Exit Site Care: Comparative Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group "chlorhexidine dressing" CHG Chlorhexidine Gluconate dressing |
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" 2% aqueous-based chlorhexidine solution and covering with a semi-permeable self-adhesive polyurethane dressing. |
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.
|
Outcome Measures
Primary Outcome Measures
- Bacteraemia rate [3 months]
presence of fever (body temperature ≥38°C) together with a positive blood culture , with no other source of infection.
- Exit site infection rate [3 months]
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.
- Tunnelitis rate [3 months]
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.
Secondary Outcome Measures
- Patient satisfaction rate [3 months]
SCALE 18 Degree of perception of positive expectations, of the NOC taxonomy (5-point Likert-type scale where 1- Not at all satisfied, 2- Somewhat satisfied, 3- Moderately satisfied, 4- Very satisfied, 5- Completely satisfied) will be used.
- Dressing-related skin alterations rate [3 months]
be assessed at each haemodialysis session, using the NOC taxonomy: [110115] Skin lesions o SCALE 14 Degree of a negative or adverse state or response: -Serious - Substantial - Moderate - Mild - None
- Dressing-related skin alterations rate [3 months]
be assessed at each haemodialysis session, using the NOC taxonomy: [110121] Erythema o SCALE 14 Degree of a negative or adverse state or response: Serious - Substantial - Moderate - Mild - None
Eligibility Criteria
Criteria
Inclusion Criteria:
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Be included in the haemodialysis programme in our unit.
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Being a carrier of a tunneled central venous catheter as vascular access.
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Remain on haemodialysis treatment for at least 3 months in our unit.
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Consent to participate in the study.
Exclusion Criteria:
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Allergy or hypersensitivity to chlorhexidine.
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Active catheter-related infection.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Raquel Pelayo Alonso | Santander | Cantabria | Spain | 39008 |
Sponsors and Collaborators
- Hospital Universitario Marqués de Valdecilla
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- HUMV-PIE2020-02