Trial Outcomes & Findings for Chlorhexidine Dressings for Hemodialysis Catheter Exit Site Care: Comparative Study (NCT NCT05855616)

Results Overview

presence of fever (body temperature ≥38°C) together with a positive blood culture , with no other source of infection.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

53 participants

Primary outcome timeframe

3 months

Results posted on

2024-02-07

Participant Flow

Participant milestones

Participant milestones
Measure	Group "Chlorhexidine Dressing" CHG Chlorhexidine Gluconate dressing 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.	Group "Solution" 2% aqueous-based chlorhexidine solution and covering with a semi-permeable self-adhesive polyurethane dressing. 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.
Overall Study STARTED	26	27
Overall Study COMPLETED	25	25
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Group "Chlorhexidine Dressing" CHG Chlorhexidine Gluconate dressing 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.	Group "Solution" 2% aqueous-based chlorhexidine solution and covering with a semi-permeable self-adhesive polyurethane dressing. 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.
Overall Study Lost to Follow-up	1	2

Baseline Characteristics

Chlorhexidine Dressings for Hemodialysis Catheter Exit Site Care: Comparative Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group "Solution" n=25 Participants Clinical characteristics of the "solution" group	Group "Chlorhexidine Dressing" n=25 Participants Clinical characteristics of the "chlorhexidine dressing" group	Total n=50 Participants Total of all reporting groups
Age, Continuous	70 years STANDARD_DEVIATION 13 • n=5 Participants	68 years STANDARD_DEVIATION 15 • n=7 Participants	69 years STANDARD_DEVIATION 15 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	13 Participants n=7 Participants	27 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	25 Participants n=5 Participants	25 Participants n=7 Participants	50 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Spain	25 participants n=5 Participants	25 participants n=7 Participants	50 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Patients with tunneled central venous catheter for hemodialysis

presence of fever (body temperature ≥38°C) together with a positive blood culture , with no other source of infection.

Outcome measures

Outcome measures
Measure	Control Arm "Group Solution" n=25 Participants 2% aqueous-based chlorhexidine solution and covering with a semi-permeable self-adhesive polyurethane dressing.	Experimental Arm "Chlorhexidine Dressing" n=25 Participants Cleaning of the exit site with physiological saline (0.9%), drying with sterile gauze, application of semipermeable polyurethane dressing with self-adhesive 2% chlorhexidine gluconate
Bacteraemia Rate	2 episodes	1 episodes

PRIMARY outcome

Timeframe: 3 months

Population: patients with tunneled central venous catheters for hemodialysis

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.

Outcome measures

Outcome measures
Measure	Control Arm "Group Solution" n=25 Participants 2% aqueous-based chlorhexidine solution and covering with a semi-permeable self-adhesive polyurethane dressing.	Experimental Arm "Chlorhexidine Dressing" n=25 Participants Cleaning of the exit site with physiological saline (0.9%), drying with sterile gauze, application of semipermeable polyurethane dressing with self-adhesive 2% chlorhexidine gluconate
Exit Site Infection Rate	2 episodes	12 episodes

PRIMARY outcome

Timeframe: 3 months

Population: patients with tunneled central venous catheters for hemodialysis

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.

Outcome measures

Outcome measures
Measure	Control Arm "Group Solution" n=25 Participants 2% aqueous-based chlorhexidine solution and covering with a semi-permeable self-adhesive polyurethane dressing.	Experimental Arm "Chlorhexidine Dressing" n=25 Participants Cleaning of the exit site with physiological saline (0.9%), drying with sterile gauze, application of semipermeable polyurethane dressing with self-adhesive 2% chlorhexidine gluconate
Tunnelitis Rate	0 episodes	0 episodes

SECONDARY outcome

Timeframe: 3 months

Population: Patients with tunneled central venous catheter for hemodialysis

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.

Outcome measures

Outcome measures
Measure	Control Arm "Group Solution" n=25 Participants 2% aqueous-based chlorhexidine solution and covering with a semi-permeable self-adhesive polyurethane dressing.	Experimental Arm "Chlorhexidine Dressing" n=25 Participants Cleaning of the exit site with physiological saline (0.9%), drying with sterile gauze, application of semipermeable polyurethane dressing with self-adhesive 2% chlorhexidine gluconate
Patient Satisfaction Rate Completely satisfied	12 Participants	17 Participants
Patient Satisfaction Rate Not at all satisfied	0 Participants	0 Participants
Patient Satisfaction Rate Somewhat satisfied	0 Participants	2 Participants
Patient Satisfaction Rate Moderately satisfied	3 Participants	1 Participants
Patient Satisfaction Rate Very satisfied	10 Participants	5 Participants

SECONDARY outcome

Timeframe: 3 months

Population: Hemodialysis sessions performed during the follow-up period are analyzed.

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.

Outcome measures

Outcome measures
Measure	Control Arm "Group Solution" n=1004 Hemodialysis sessions 2% aqueous-based chlorhexidine solution and covering with a semi-permeable self-adhesive polyurethane dressing.	Experimental Arm "Chlorhexidine Dressing" n=1073 Hemodialysis sessions Cleaning of the exit site with physiological saline (0.9%), drying with sterile gauze, application of semipermeable polyurethane dressing with self-adhesive 2% chlorhexidine gluconate
Percentage of Hemodialysis Sessions With Skin Lesions Not Skin Lesions	99.1 percentage of sessions	99 percentage of sessions
Percentage of Hemodialysis Sessions With Skin Lesions Skin Lesions	0.9 percentage of sessions	1 percentage of sessions

SECONDARY outcome

Timeframe: 3 months

Population: Hemodialysis sessions performed during the follow-up period are analyzed.

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.

Outcome measures

Outcome measures
Measure	Control Arm "Group Solution" n=1004 Hemodialysis sessions 2% aqueous-based chlorhexidine solution and covering with a semi-permeable self-adhesive polyurethane dressing.	Experimental Arm "Chlorhexidine Dressing" n=1073 Hemodialysis sessions Cleaning of the exit site with physiological saline (0.9%), drying with sterile gauze, application of semipermeable polyurethane dressing with self-adhesive 2% chlorhexidine gluconate
Percentage of Hemodialysis Sessions With Dressing-related Skin Erythema Rate Not Erythema	98.2 percentage of sessions	99.2 percentage of sessions
Percentage of Hemodialysis Sessions With Dressing-related Skin Erythema Rate Erythema	1.8 percentage of sessions	0.8 percentage of sessions

Adverse Events

Group "Chlorhexidine Dressing"

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group "Solution"

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Raquel Pelayo Alonso, Head Nurse of Nephrology, RN

Marques de Valdecilla University Hospital

Phone: +34 649443488

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place