Effects of Topical Gentamicin on the Prevention of Peritoneal Dialysis Related Infection

Study Overview
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Brief Summary
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Peritoneal dialysis-related infection is a complication that leads to peritoneal dialysis catheter removal or patient death. The present study aimed to investigate peritoneal dialysis-related infection, causative pathogens resulting in topical 2% mupirocin ointments period compare with 0.1% gentamicin cream period. Rate of catheter removal, time to first peritoneal dialysis-related infection after apply gentamicin cream.

Official Title
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Effects of Topical Gentamicin on the Prevention of Peritoneal Dialysis Related Infection Caused by Pseudomonas Aeruginosa

Conditions
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Peritoneal Dialysis-related Infection

Intervention / Treatment
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* Drug: Mupirocin
* Drug: Gentamicin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age greater than or equal to 20 years End stage renal disease patients on peritoneal dialysis follow up at Phramongkutklao hospital's peritoneal dialysis clinic between January 1, 2021 to March 31, 2023 Start peritoneal dialysis or follow up at Phramongkutklao hospital's peritoneal dialysis clinic at least 90 days before recruited Use topical mupirocin ointment for prevention of peritoneal dialysis-related infection between January 1, 2021 to December 31, 2021 Can be used LINE application throughout the study Exclusion Criteria: Allergy to gentamicin or components Previous systemic antibiotics use within 90 days before recruited Previous peritoneal dialysis-related infection within 28 days before recruited Immunosuppressants used Prospective follow up less than 2 months Don't sign informed consent

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Single group: topical mupirocin ointment retrospective period compare with gentamicin prospective period
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mupirocin and Gentamicin<br>2% mupirocin ointments apply at exit-site once daily after wound cleaning before recruit in the study then use 0.1% gentamicin cream apply at exit-site once daily after wound cleaning after entry to the study. | Drug: Mupirocin<br>* Apply mupirocin ointments for prevention of peritoneal dialysis-related infection between 1 January 2021 to 31 December 2021<br>* Other names: BACIDAL;Drug: Gentamicin<br>* Apply gentamicin creams for prevention of peritoneal dialysis-related infection for 1 year start after 1 January 2022<br>* Other names: GENTREX;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Exit-site infection in mupirocin compared with gentamicin group | Exit-site infection diagnosis by physician. Retrospective data collection from patient's medical records in mupirocin group Prospective data collection from patient's medical records in gentamicin group. | All exit-site infection episodes occurred last year in mupirocin group and all exit-site infection episodes have occurred after apply 0.1% grntamicin cream for 1 year. | 
| Rate of Infectious peritonitis in mupirocin compared with gentamicin group | Infectious peritonitis diagnosis by physicians. Retrospective data collection from patient's medical records in mupirocin group Prospective data collection from patient's medical records in gentamicin group | All infectious peritonitis episodes occurred last year in mupirocin group and all infectious peritonitis episodes have occurred after apply 0.1% grntamicin cream for 1 year. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and percentage Causative pathogens of Exit-site infection in mupirocin compared with gentamicin group | Retrospective data collection from patient's medical records in mupirocin group Prospective data collection from patient's medical records in gentamicin group | All pathogenic organisms of exit-site infection episodes occurred last year in mupirocin group and all pathogenic organisms of exit-site infection episodes have occurred after apply 0.1% grntamicin cream for 1 year. | 
| Number and percentage Causative pathogens of Infectious peritonitis in mupirocin compared with gentamicin group | Retrospective data collection from patient's medical records in mupirocin group Prospective data collection from patient's medical records in gentamicin group | All pathogenic organisms of infectious peritonitis episodes occurred last year in mupirocin group and all pathogenic organisms of infectious peritonitis episodes have occurred after apply 0.1% grntamicin cream for 1 year. | 
| Percentage of catheter removal due to peritoneal dialysis-related infection | Prospective data collection from patient's medical records in gentamicin group | Retrospective period at least 1 year before recruit to the study, Prospective period at least 1 year after entry to the study. | 
| Time to first peritoneal dialysis-related infection after gentamicin application | Retrospective data collection from patient's medical records in mupirocin group Prospective data collection from patient's medical records in gentamicin group. Peritoneal-related infection diagnosis by physicians. Prospective data collection from patient's medical records in gentamicin group | Prospective period at least 1 year after entry to the study. | 
| Drug susceptibility of causative pathogens of peritoneal dialysis-related infection | Drug susceptibility test by broth micro-dilution and E-test. Retrospective data collection from patient's medical records in mupirocin group Prospective data collection from patient's medical records in gentamicin group | Retrospective period at least 1 year before recruit to the study, Prospective period at least 1 year after entry to the study. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peritoneal dialysis-related infection, Infectious peritonitis, Exit-site infection, Infection rate, Drug susceptibility