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Mupirocin 2% Ointment Vs Spray Antibiotics on Temporary Hemodialysis Catheter

The Effect of Mupirocin 2% Ointment on the Duration of Stay of Temporary Hemodialysis Catheter Compared to Other Spray Antibiotics

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05874219
Enrollment
150
Registered
2023-05-24
Start date
2023-04-10
Completion date
2023-05-25
Last updated
2023-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodialysis Catheter Infection, Hemodialysis Complication

Brief summary

In dialysis centers, many patients are undergoing hemodialysis simultaneously, which facilitates the spread of microorganisms by direct or indirect contact through the devices, equipment, surface contact, and hands of health profession Over time, catheters are prone to higher rates of infection, thrombosis, and central venous stenosis, it has also been shown that catheters are an independent (of infection) inflammatory stressor and lead to increased morbidity . Catheters are aptly referred to as a bacterial highway, and a biofilm formation around the catheter is often the breeding ground of bacteria and fungi, which can easily spread to the bloodstream Infectious complications are the most serious with regards to patient morbidity and mortality. The incidence could be from 3.8 to5.5 episodes per 1000 days Migration of micro-organism along the external surface of the catheter is probably the most common route of infection through skin and represents 58% .HD catheter has biofilm formation on their surfaces and this serves as a good reservoir for micro-organisms Most patients with end stage renal disease (ESRD) starting hemodialysis through hemodialysis catheter about 9 % in Egypt and most of them require several hemodialysis catheters before maturation of arterio -venous fistula and even after stopping it.

Detailed description

Patients receiving hemodialysis have a high risk of infection due to the immunosuppressive effects caused by ESRD, comorbidities, inadequate nutrition and the need for maintenance of vascular access for long periods. The catheters are rightfully the least preferred modality and, in an ideal setting, no patient should have a catheter as access. Despite the perils associated with dialysis catheters, their use has increased to almost 70% incident dialysis initiation with catheters In dialysis centers, many patients are undergoing hemodialysis simultaneously, which facilitates the spread of microorganisms by direct or indirect contact through the devices, equipment, surface contact, and hands of health profession Over time, catheters are prone to higher rates of infection, thrombosis, and central venous stenosis, it has also been shown that catheters are an independent (of infection) inflammatory stressor and lead to increased morbidity Catheters are aptly referred to as a bacterial highway, and a biofilm formation around the catheter is often the breeding ground of bacteria and fungi, which can easily spread to the bloodstream Infectious complications are the most serious with regards to patient morbidity and mortality. The incidence could be from 3.8 to5.5 episodes per 1000 days Migration of micro-organism along the external surface of the catheter is probably the most common route of infection through skin and represents 58% .HD catheter has biofilm formation on their surfaces and this serves as a good reservoir for micro-organisms Most patients with end stage renal disease (ESRD) starting hemodialysis through hemodialysis catheter about 9 % in Egypt and most of them require several hemodialysis catheters before maturation of arterio -venous fistula and even after stopping it.

Interventions

DRUGLocal antibiotic spray Neomycin sulphate 165,000 IU + Bacitracin zinc 12,500 IU

The intervention Sprayed 1 to 3 times /day

10 mm of mupirocin ointment squeezed directly on to their exit sites from a 15 g tube with an outlet diameter of 5 mm

Sponsors

Future University in Egypt
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

-Adults patients receiving long-term hemodialysis using temporary right internal jugular hemodialysis catheter

Exclusion criteria

* Age below 16 * Noncompliance patients * Mechanical complications

Design outcomes

Primary

MeasureTime frameDescription
Catheter related infection45 daysCatheter related infection which will manifest by fever rigor and obligatory remove of the catheter.

Secondary

MeasureTime frameDescription
The average duration of HD catheter45 daysThe average duration of HD catheter

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026