Chlorhexidine Gluconate Versus Mupirocin Ointment in the Prevention of Peritoneal Dialysis-Related Infection
Chlorhexidine Gluconate Versus Mupirocin Ointment in the Prevention of Peritoneal Dialysis-Related Infection
This pilot study aims to evaluate effectiveness, safety, and cost-utility of chlorhexidine
 gluconate (CHG)-soaked cloths compares to mupirocin ointment and exit site usual care (normal
 saline) with aseptic technique in prevention of PD-related infection. It is a multicenter,
 double-blind, stratified randomized controlled trial. Participants will be randomized to
 three arms mupirocin, usual care, or CHG-soaked cloths in a ratio of 1:1:1. They will be
 followed up 24 months or completion of PD. The primary outcome is PD-related infection
 (PD-related peritonitis of exit-site and tunnel infection). Secondary outcomes are
 infection-related catheter removal and technique failure, nasal and exit-site Staphylococcus
 aureus colonization, health-related quality of life, mental health, medication adherence,
 safety, adverse events related to treatments such as skin irritation, rash, etc. Costs
 include providers and patients expenses. The utility is assessed using the EuroQol (EQ),
 five-dimensional (5D), five-level (5L) version. The results of this study are anticipated
 nephrologists and health care professional involving to PD in decision-making for a plan to
 prevent PD-related infection. In addition, the results will lead to clinical guideline
 development a prevention of PD-related infection.
Peritoneal dialysis (PD) is one of renal replacement therapy used for end-stage renal
 disease. Since 2011, there has been increasing numbers of patients under "PD First" policy of
 the Thai government. The most common PD related complication is PD-related infection
 categorized PD-related peritonitis, and exit site and tunnel infection. Although possible to
 treat PD-related infection, the incidence of technical failure and death due to peritonitis
 are still high in Thailand. PD-related infections mainly caused by Staphylococcus aureus. To
 prevent PD-related infection, cleaning with aseptic solvents using aseptic technique and
 prevent infection by prescribing prophylactic antibiotics are recommended. The International
 Society for Peritoneal Dialysis (ISPD) has recommended position statement of the regular use
 of mupirocin ointment around the catheter exits point and apply in nasal cavity. However,
 there is rising concern of long term use of mupirocin for mupirocin resistance of S. aureus.
 CHG is antiseptic use in clinical practice. It can coat at least 12 hours on skin and has
 anti-bacterial covered in both grams negative and positive. Several meta-analysis studies
 showed effectiveness of CHG in the prevention of hospitals infection i.e. reduces
 catheter-related sepsis, postoperative infection, and microbial resistance. According to
 PD-related infection, CHG has very little evidence of its effectiveness. This pilot study
 aims to evaluate effectiveness, safety, and cost-utility of CHG-soaked cloths compares to
 mupirocin ointment and exit site usual care (normal saline and povidone-iodine) with aseptic
 technique in prevention of PD-related infections. It is a multicenter, double-blind,
 stratified randomized controlled trial. Participants will be randomized to three arms
 mupirocin, usual care, or CHG-soaked cloths. They will be followed up 24 months or
 completetion of PD. The primary outcome is PD-related infection (PD-related peritonitis or
 exit-site and tunnel infection). Secondary outcomes are infection-related catheter removal
 and technique failure, nasal and exit-site Staphylococcus aureus colonization, health-related
 quality of life, mental health, medication adherence, safety, adverse events related to
 treatments such as skin irritation, rash, etc. For cost-utility analysis, costs include
 providers and patients expenses. The Utility is assessed using EQ-5D-5L.
Inclusion Criteria:

 1. Patients with end-stage renal disease who were undergoing peritoneal dialysis; either
 continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD)

 Exclusion Criteria:

 1. History of psychological illness or condition that interferes with the ability to
 understand or comply with the requirements of the study

 2. Recent (within 1 month) exit-site or tunnel infection, or peritonitis

 3. Known hypersensitivity to, or intolerance of, chlorhexidine gluconate, or mupirocin

 4. Current or recent (within 1 month) treatment with antibiotics administered by any
 route

 5. Nasal carriage of mupirocin-resistant Staphylococcus aureus or chlorhexidine-resistant
 S. aureus