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Daily Chlorhexidine Care at the Exit Site in Peritoneal Dialysis Patients

E

E-DA Hospital

Status and phase

Completed
Phase 4

Conditions

Peritoneal Dialysis Catheter Exit Site Infection

Treatments

Drug: Chlorhexidine gluconate

Study type

Interventional

Funder types

Other

Identifiers

NCT02446158
EDAHP99020

Details and patient eligibility

About

Chlorhexidine is used in central line dressing changes and is effective in reducing line infections. It is unclear if daily chlorhexidine care at the exit site in peritoneal dialysis (PD) patients can reduce the risk of Staphylococcus aureus (SA) colonization or exit site infection.

Full description

There is no consensus on what regimen is optimal for topical care of the peritoneal dialysis (PD) catheter exit site. Several methods including soap and water, povidone-iodine, hydrogen peroxide, chlorhexidine, and topical antimicrobial agents such as gentamicin or mupirocin cream have been described for care of the exit site. However, many of these studies were small or short-term and lacked longitudinal evaluation of bacterial decolonization efficacy. Staphylococcus aureus (SA) is one of most common causes of peritonitis and exit-site infection and is associated with a high PD catheter removal rate. Carriers of SA had a higher rate of exit-site infection than non-carriers. In previous studies, staphylococcal carriage prophylaxis using either mupirocin or gentimicin ointment in the nares or exit site significantly reduced the rate of exit-site infection due to SA. However, emerging antibiotic resistance is a concern. In addition, MRSA infection in PD patients is more severe than other pathogens; therefore, choosing a good antiseptic for SA and/or MRSA decolonization is important.

In recent years, the use of chlorhexidine in bathing or central line dressing changes was implemented to prevent bacterial colonization and multidrug resistant bacterial infections and was also used in hemodialysis patients. Data regarding chlorhexidine used in the catheter care of PD patients are limited and it is unclear if the use of chlorhexidine for exit site care contributes to long-term bacterial decolonization and acts as a prophylaxis for exit site infections.

Enrollment

89 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • patients > 20 years old who received PD for more than 3 months

Exclusion criteria

  • a history of psychological illness or condition that interferes with caring of a wound
  • recent (within 1 month) exit-site infection, peritonitis, or tunnel infection
  • recent treatment with an antibiotic administered by any route in the last month
  • or known hypersensitivity to or intolerance of chlorhexidine or mupirocin

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

89 participants in 2 patient groups

Chlorhexidine gluconate
Experimental group
Description:
PD (peritoneal dialysis) paitents with daily chlorhexidine exit site care
Treatment:
Drug: Chlorhexidine gluconate
Control group
No Intervention group
Description:
PD (peritoneal dialysis) patients with usual (Normal saline) exit site care

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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