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Chlorhexidine Dressings for Hemodialysis Catheter Exit Site Care: Comparative Study
NA trial testing Group "chlorhexidine dressing" in Hemodialysis Catheter Infection in 53 participants. Completed in 30 December 2022.
| Lead sponsor | Hospital Universitario Marqués de Valdecilla |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | prevention |
| Enrollment | 53 |
| Start date | 1 November 2020 |
| Primary completion | 1 July 2022 |
| Estimated completion | 30 December 2022 |
| Sites | 1 location across Spain |
Hospital Universitario Marqués de Valdecilla
18 and older, any sex, with Hemodialysis Catheter Infection. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
presence of fever (body temperature ≥38°C) together with a positive blood culture , with no other source of infection.
| Group | Value | 95% CI |
|---|---|---|
| Control Arm "Group Solution" | 2 | |
| Experimental Arm "Chlorhexidine Dressing" | 1 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Group "Chlorhexidine Dressing" | 2 | |
| Group "Solution" | 12 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Group "Chlorhexidine Dressing" | 0 | |
| Group "Solution" | 0 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Group "Chlorhexidine Dressing" | 0 | |
| Group "Solution" | 0 | |
| Group "Chlorhexidine Dressing" | 0 | |
| Group "Solution" | 2 | |
| Group "Chlorhexidine Dressing" | 3 | |
| Group "Solution" | 1 | |
| Group "Chlorhexidine Dressing" | 10 | |
| Group "Solution" | 5 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Group "Chlorhexidine Dressing" | 99.1 | |
| Group "Solution" | 99 |
| Group | Value | 95% CI |
|---|---|---|
| Group "Chlorhexidine Dressing" | 0.9 | |
| Group "Solution" | 1 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Group "Chlorhexidine Dressing" | 98.2 | |
| Group "Solution" | 99.2 |
| Group | Value | 95% CI |
|---|---|---|
| Group "Chlorhexidine Dressing" | 1.8 | |
| Group "Solution" | 0.8 |
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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