Daily Chlorhexidine Care at the Exit Site in Peritoneal Dialysis Patients
A Randomized Trial of Daily Chlorhexidine Care at the Exit Site in Peritoneal Dialysis Patients for Bacterial Decolonization and Prevention of Infection
1 other identifier
interventional
89
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started May 2010
Shorter than P25 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 10, 2015
CompletedFirst Posted
Study publicly available on registry
May 18, 2015
CompletedMay 18, 2015
May 1, 2015
1 year
May 10, 2015
May 13, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
exit site bacterial colonization status
We performed swab cultures at the exit site and nasal site every month during follow-up at the hospital and analyzed the bacterial colonization status at 6 and 12 months as the primary outcome.
1 year
Secondary Outcomes (1)
The exit-site infection rate
1 year
Study Arms (2)
Chlorhexidine gluconate
EXPERIMENTALPD (peritoneal dialysis) paitents with daily chlorhexidine exit site care
Control group
NO INTERVENTIONPD (peritoneal dialysis) patients with usual (Normal saline) exit site care
Interventions
The intervention group received daily cleaning of the exit site and application of 4% chlorhexidine (Antigerm Solution, Shining BioMedical Com. Ltd) with a swab. The chlorhexidine was rinsed off after 3 min of air drying and then gauze was applied.
Eligibility Criteria
You may qualify if:
- patients \> 20 years old who received PD for more than 3 months
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- E-DA Hospitallead
Related Publications (1)
Wang HH, Hung SY, Chang MY, Lee YC, Lin HF, Lin TM, Yang SP, Lin HH, Yang SC, Wang JL. Bacterial colonization patterns in daily chlorhexidine care at the exit site in peritoneal dialysis patients-A prospective, randomized controlled trial. PLoS One. 2017 Oct 5;12(10):e0184859. doi: 10.1371/journal.pone.0184859. eCollection 2017.
PMID: 28981543DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 10, 2015
First Posted
May 18, 2015
Study Start
May 1, 2010
Primary Completion
May 1, 2011
Study Completion
May 1, 2011
Last Updated
May 18, 2015
Record last verified: 2015-05