Comparative Study of Two Haemodialysis Catheter Exit Site Dressings: Chlorhexidine Gluconate Dressing vs Chlorhexidine 2% Solution.
Phase: NA
Conditions: Hemodialysis Catheter Infection
Sponsor: Hospital Universitario Marqués de Valdecilla

Study protocol 
 
Comparative study of two hemodialysis catheter exit site dressing 
regimens: chlorhexidine gluconate dressing vs chlorhexidine 2% 
solution. 
 
Identifier: NCT05855616 Unique Protocol ID: HUMV-PIE2020-02 
 
Date: 20 september 2021 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Hypothesis 
Primary:  
Curing the exit site of the indwelling hemodialysis catheter with 2% self-adhesive 
chlorhexidine gluconate semi-permeable polyurethane dressings (AGC) will correlate 
with a lower incidence of catheter-related infections (bacteremia, exit site infection, and 
tunnelitis), than healing with chlorhexidine in 2% aqueous solution and covered with a 
dressing of self-adhesive semi-permeable polyurethane dressings. 
Secondary: 
• 
The degree of comorbidity, previous infections, time on renal replacement 
therapy, and catheter duration will correlate with a higher rate of catheter-
related infections. 
• 
Hemodialysis catheter exit site dressing with AGC dressings will correlate with 
higher patient satisfaction than dressing with 2% chlorhexidine solution and 
covered with a self-adhesive semi-permeable polyurethane dressing. 
Objectives 
Main:  
To compare the rate of catheter-related infections (bacteremia, exit site infection and 
tunnelitis) between hemodialysis catheter exit site dressing with self-adhesive ACG 
dressings and dressing with 2% chlorhexidine solution and covered with self-adhesive 
semi-permeable polyurethane dressing. 
Secondary: 
- To evaluate factors related to the incidence of hemodialysis catheter-related infections. 
- To evaluate the incidence of dressing-related skin alterations. 
- To assess patient satisfaction with regard to the type of hemodialysis catheter exit site 
dressing. 
Methodology 
Design: Experimental, controlled and randomized study. Patients will be randomized 
from sealed envelopes. These envelopes will contain the outflow orifice treatment group 
to which each patient will be assigned. The envelopes will be numbered and the patients 
will be included consecutively. The contents of the envelopes will be made by a person 
outside the research team. A member of the research team will invite the patient to 
participate in the study, informing him/her of the details of the study orally and in writing 
(see patient information sheet), after his/her acceptance and signature of the informed 
consent, the patient will be randomized. Duration: November 2020 to December 2022. 
Intervention: 
- 
Cure guideline control group- cleansing exit orifice with physiological saline 
(0.9%), drying with sterile gauze, disinfection with 2% water-based 
chlorhexidine solution, environmental drying for 30 seconds and covering with 
self-adhesive semi-permeable polyurethane dressing. 
- 
Cure guideline experimental group - cleaning of the exit orifice with physiological 
saline (0.9%), drying with sterile gauze, application of a semi-permeable 
polyurethane dressing with 2% self-adhesive chlorhexidine gluconate, centering 
the chlorhexidine gluconate band well in the exit orifice. 

Outflow orifice curettage will be performed by experienced nurses from our 
hemodialysis unit, after a briefing on the study methodology. In both cases the 
treatment will be performed weekly (first day of the week), or whenever there is 
exudate from the exit site or detachment of the dressing; before connecting the 
catheter to the hemodialysis monitor. In both cases, the treatment will be carried 
out under maximum aseptic measures: previous hand hygiene, sterile material and 
treatment, and use of masks by the patient, nurse and nursing assistant. The 
connection to the hemodialysis monitor will be performed under these aseptic 
measures, covering the connection between the lines and the catheter with gauze 
impregnated with 2% water-based chlorhexidine solution and a sterile cloth. In 
addition, a bioconnector is used for hemodialysis catheters. 
Population: patients on renal replacement therapy with hemodialysis whose 
vascular access is an indwelling catheter. Fifty patients will be included (25 patients 
in the control group - chlorhexidine 2% solution and covered with self-adhesive 
transparent polyurethane dressing - and 25 patients in the experimental group - 
with self-adhesive ACG dressings). The sample size calculation was performed with 
the GRANMO program version 7.12, accepting an alpha risk of 0.05 and a beta risk 
of 0.2 in a bilateral contrast, to detect as statistically significant the difference 
between two proportions, which for the control group is expected to be 25% and the 
experimental group 5%. A loss-to-follow-up rate of 10% has been estimated. 
Inclusion criteria: 
- 
Be included in hemodialysis program in our unit. 
- 
Be a carrier of a catheter as vascular access, inserted 1 month prior to 
inclusion in the study. 
- 
Remain on hemodialysis treatment for at least 3 months at the dialysis center 
- 
Consent to participate in the study. 
Exclusion criteria: 
- 
Allergy or hypersensitivity to chlorhexidine or polyurethane dressing 
- 
Use of a non-tunneled venous catheter as vascular access. 
- 
Active catheter-related infection at the time of inclusion in the study. 
Causes of patient loss: 
- 
Exitus. 
- 
Renal transplantation 
- 
Use of arteriovenous fistula as vascular access. 
- 
Transfer to peritoneal dialysis program. 
- 
Hypersensitivity reaction to chlorhexidine gluconate. 
- 
Exit from hemodialysis program due to other clinical situations. 
Follow-up period: Patients carrying an indwelling catheter: 3 months. 
Variables: 
a) Patient clinical variables- age, sex, etiology of renal disease according to 
ERA/EDTA code, degree of comorbidity according to the modified Charlson Index 
for patients with renal disease, time on renal replacement therapy with 
hemodialysis. 
b) Catheter affiliation variables - design (twin or single), material (carbonate or 
polyurethane), date of insertion, date of removal, vein of insertion, previous 
catheter-related infections (bacteremia, tunnelitis, exit site infection). 

c) Catheter-related infections during the follow-up period- will be defined as: 
• 
Bacteremia- presence of fever (body temperature ≥38°C) along with a positive 
blood culture, with no other focus of infection. 
• 
Exit site infection- positive culture of pericatheter smear together with presence 
of inflammatory signs limited to 2 cm around the cutaneous exit site, with no 
upper extension to the catheter cuff if tunneled. 
• 
Tunnelitis- appearance of inflammatory signs extending beyond 2 cm from the 
cutaneous exit site and in the subcutaneous tract of the catheter (tunnelitis). It 
may or may not be associated with fever and bacteremia, and may be 
accompanied by purulent exudate through the cutaneous exit site. 
In case of clinical suspicion of bacteremia due to fever (body temperature ≥38ºC), 
2 blood cultures will be taken 30 minutes apart, from aerobic and anaerobic germs, 
directly from the arterial branch of the catheter. 
The exit orifice will be inspected at each dressing, and the nurse in charge will take 
a photograph of it before performing the dressing, to check for the presence of signs 
of infection by the investigating team. In the presence of signs of infection, a culture 
of the pericatheter smear will be taken before the exit site is cured. 
d) Patient satisfaction with the treatment regimen. - Patients will be surveyed 
after the follow-up period of the study about discomfort related to the type of 
treatment: pain on withdrawal, presence of pruritus, loss of adherence, alteration 
of body image, degree of comfort. To assess these aspects, 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. 
e) Incidence of dressing-related skin alterations. - will be assessed at each 
hemodialysis session, using the following NOCs: 
- [110115] Skin lesions 
- 110121] Erythema 
SCALE 14 Degree of a negative or adverse condition or response (Severe - Substantial 
- Moderate - Mild – None) 
Data collection and analysis: An Excel-type data collection sheet will be created with 
the variables to be studied. The variables will be introduced by a member of the research 
team and will be extracted from the patients' clinical records (clinical reports, dialysis 
evolution sheets, catheter evolution sheets and analytical results). The survey of 
satisfaction with the treatment will be carried out by a member of the research team at 
the end of the follow-up period. 
A descriptive analysis of the variables under study will be performed: in the case of 
quantitative variables, measures of central tendency and dispersion appropriate to the 
distribution and their 95% confidence intervals will be calculated; in the case of 
categorical variables, the frequency and percentage will be calculated. The catheter-
related infection rate (bacteremia, exit site infection and tunnelitis) will be calculated 
using the following formula: number of catheter-related infections/ days of follow-up x 
1000; both for the total number and by intervention group and type of catheter. In the 
case of comparisons between categorical variables, the chi-square test or Fisher's exact 
test will be used when necessary. Continuous variables will be compared using Student's 
t-test or Mann Whitney U-test, depending on their distribution. For the study of variables 
associated with the presence of catheter-related infections, a multiple logistic regression 
analysis will be performed including as independent variables age, sex, etiology of renal 
disease, degree of comorbidity, time on renal replacement therapy with hemodialysis, 

type and model of catheter, duration of the catheter, location, and presence of previous 
catheter-related infections. The results will be considered significant if the critical level 
observed is less than 5% (p<0.05). Statistical analysis will be performed with the PSPP 
statistical package. 
Limitations of the study 
The main limitation of the study is the follow-up period of the tunneled catheters, which 
is limited to three months, due to the lack of resources for the acquisition of a greater 
number of self-adhesive chlorhexidine gluconate dressings. 
Ethical considerations 
Approval of the project will be requested from the Cantabria Drug Research Ethics 
Committee (CEIm de Cantabria). The research team declares that it has no conflict of 
interest with respect to the products used in the study. 
All patients will be passed the Information and Informed Consent Sheet prior to their 
inclusion in the study, such consent will be made based on the provisions of Regulation 
(EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on Data 
Protection (RGPD); and the Organic Law 3/2018, of December 5, on the Protection of 
Personal Data and guarantee of digital rights. 
The research will be conducted on the basis of the Declaration of Helsinki, complying 
with the standards of Good Clinical Practice (GCP) as applicable. 
Those patients who wish to receive the intervention but not participate in the project 
will be provided with the same intervention as the experimental group. 
The custody of all documentation related to the project will be carried out by the 
principal investigator of the project, for a period of 5 years, after which it will be 
destroyed following the standardized procedure. 
Institutional Authorizations 
The study has the authorization of the Chief of the Nephrology Service of the Marqués 
de Valdecilla University Hospital. Once the project has been authorized by the CEIm of 
Cantabria, authorization will be requested from the Management of the Marqués de 
Valdecilla University Hospital to carry it out. 
Informed consent 
The participant will be informed what the study consists of (verbally and in writing) and 
will be invited to participate by signing the informed consent. 
All data will be treated with strict confidentiality in accordance with the Organic Law 
3/2018, of December 5, on Personal Data Protection and guarantee of digital rights. In 
accordance with the provisions of the aforementioned legislation, the patient may 
exercise the rights of access, modification, opposition and cancellation of data, for which 
he/she should contact the principal investigator of the study.