NCT03798171

Reduction of Exit Site Infection in Peritoneal Dialysis Patients

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: Tel-Aviv Sourasky Medical Center · Other Government
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

In peritoneal dialysis patients, the presence of the catheter presents a risk of infection - exit site infection, tunnel infection or peritonitis. In our dialysis unit, we noticed a rise in exit-site infection associated with organisms derived from contaminated water. Therefore we decided to change the exit-site care in our unit. This is a prospective observational single center study, that compares exit-site infection rated in peritoneal dialysis patients before and after our policy change for exit-site care.

Detailed description

Peritoneal dialysis is a method for renal replacement therapy that uses the peritoneal membrane for exchange of fluids and dissolved substance . A catheter is surgically inserted with one end in the abdomen and the other protruding from the skin, in order to allow fluid exchange. The presence of the catheter presents a risk of infection - exit site infection, tunnel infection or peritonitis - a cause of morbidity and treatment failure. Infection prevention is based, among other measures, on aseptic handeling of catheter exit-site. In our dialysis unit, we noticed a rise in pseudomonas exit-site infection and other organisms associated with contaminated water. Therefore we decided to change the exit-site care in our unit. Similar to central catheters handeling, we decided to cover the catheter exit-site during water exposure, and to change the prophylactic exit-site antibiotic regimen. This is a prospective observational single center study. All peritoneal dialysis patients in our institue will be counseled about change in exit-site care. For prevention of water exposure the patients will use stoma bags around the catheter during showers. After the shower, the exit-site is cleaned with a chlorhexidine based solution, an antibiotic cream is applied (Mupirocin) and dressed with a clean gauze. The patients will be followed for 3 years for adverse events. The number of infectious episodes will be recorded and compared to historical data (January 2015-December 2017).

Conditions

• Peritoneal Dialysis Catheter Infection

Timeline

• Start date: 2018-05-15
• Primary completion: 2021-05-15
• Completion: 2021-05-15
• First posted: 2019-01-09
• Last updated: 2019-01-09

Locations

1 site across 1 country: Israel