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Mupirocin 2% Ointment Vs Spray Antibiotics on Temporary Hemodialysis Catheter

F

Future University in Egypt

Status and phase

Completed
Phase 3
Phase 2

Conditions

Hemodialysis Complication
Hemodialysis Catheter Infection

Treatments

Drug: Local antibiotic spray Neomycin sulphate 165,000 IU + Bacitracin zinc 12,500 IU
Drug: Mupirocin 2% ointment

Study type

Interventional

Funder types

Other

Identifiers

NCT05874219
FMASU R85/2023

Details and patient eligibility

About

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.

Full 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.

Enrollment

150 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • Age below 16
  • Noncompliance patients
  • Mechanical complications

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

150 participants in 2 patient groups

Local antibiotic spray
Experimental group
Description:
Local antibiotic spray (n=75) The intervention Sprayed 1 to 3 times /day for 45 day Neomycin sulphate 165,000 IU + Bacitracin zinc 12,500 IU Bivatracin Spray
Treatment:
Drug: Local antibiotic spray Neomycin sulphate 165,000 IU + Bacitracin zinc 12,500 IU
Mupirocin 2% ointment
Active Comparator group
Description:
(The standard) 10 mm of mupirocin ointment squeezed directly on to their exit sites from a 15 g tube with an outlet diameter of 5 mm mupirocin 2% ointment
Treatment:
Drug: Mupirocin 2% ointment

Trial contacts and locations

1

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Central trial contact

Magdy Elsharkawy, professor; Doaa Elbohy, PhD

Data sourced from clinicaltrials.gov

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