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The Effects of Anti-microbial Spray Dressing in Preventing Tenckhoff Catheter Exit Site Infection for End Stage Renal Failure Patients

The Effectiveness of a Physical Anti-microbial Spray Dressing in Preventing Tenckhoff Catheter Exit Site Infection for End Stage Renal Failure Patients

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01952964
Acronym
JUCspray
Enrollment
78
Registered
2013-09-30
Start date
2011-03-31
Completion date
2013-10-31
Last updated
2013-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Physical Damage of the Tenckhoff Catheter, Signs and Symptoms of Exit Site Infection, Skin Allery

Keywords

exit site infection, skin allergy, physical damage

Brief summary

The present study aims to compare the differences in exit site infection between patients receiving spray dressing and conventional care. The outcome measures including catheter exit site infection rate, skin allergy, catheter damage and patient satisfaction

Detailed description

Methods The study will be conducted using randomized controlled trial. Sampling The subjects will be the patients with Tenckhoff Catheter recruited from the renal team in a regional acute hospital and a satellite dialysis centre. The sampling method will be convenience sampling. The subjects will be recruited sequentially after the insertion of Tenckhoff Catheter. Inclusion criteria * Patient with established Tenckhoff Catheter for at least 3 months * Patient with skin condition healed satisfactorily Exclusion criteria * Patient presents with signs and symptoms of exit site infection e.g. purulent discharge, pain, and swab of exit cultured with positive growth. * Patient with unhealed exit site. * Patient currently requires antibiotics * Patient shows sensitive to JUC Spray Dressing or 0.05% Chlorhexidine solution (A) Control group Care of Tenckhoff catheter exit site using 0.05% Chlorhexidine solution (Guidelines on the care of peritoneal catheter exit site, Renal Unit, QEH). The detailed procedures will be introduced by the nurse according to the protocol of the unit. Please refer to Appendix II for details. Skin test with 0.05% Chlorhexidine will be carried out prior to the usage of Chlorhexidine solution for caring the exit site. For the first three days after patient has been discharged, study team members will perform telephone follow up. Patients are reminded to report for signs and symptoms of infection or physical damage of catheter noted. A routine follow up at the Renal Unit will be arranged at eight weeks intervals. (B) Intervention group Care of peritoneal catheter exit site using spray dressing. The detailed procedures will be introduced by the nurse according to the protocol of the unit. Please refer to Appendix III for details. Data collection Quantitative data collection such as demographic data, time of insertion of Peritoneal Catheter, history of allergy would be collected from patient's record. The condition of the exit site will be monitored daily by patient / carer. They are taught to report to the nurses for any abnormality noted such as signs and symptoms of infection, skin allergy and damage of the catheter. A comprehensive nursing assessment will be carried out at 8 weeks interval monthly for 6 months. Data analysis The data will be analyzed using PASW. The demographic data will be reported using means and standard deviation. Independent sample t-test will be used to compare the differences between groups. P\<0.05 will be set as significant difference. Ethical Considerations All patients participate this study are on voluntary base. Before launching of the study, ethical approval from the Research Ethical Committee, The Hong Kong Polytechnic University and Ethical Committee, Kowloon Central Cluster will be obtained. A detailed explanation of the research objectives and different interventions will be provided to the patients verbally and in the information sheet. After passing the skin test on allergy reactions, patients agree to participate will need to sign the consent form. During data collection, the research code will be assigned to each subject and the name will not be appeared on any research documentation to ensure confidentiality. The data will only be accessed by the research team members . Furthermore, the Research Ethical Committee (REC) and the Regulatory Authority of the study hospital will be granted direct access to the subject's study data for data verification. The Research Ethical Committee will spot check the clinical area during the study period to ensure research ethics are adhered and good clinical practices are maintained throughout the study.

Interventions

OTHERJUC spray dressing

Intervention group Care of Tenckhoff catheter exit site using spray dressing. The detailed procedures will be introduced by the nurse according to the protocol of the unit. Please refer to Appendix III for details. Skin test with JUC spray will be carried out prior to the usage of JUC spray dressing for caring the exit site. For the first three days after patient has been discharged, study team members will perform telephone follow up. Patients are reminded to report for signs and symptoms of infection or physical damage of catheter noted. A routine follow up at the Renal Unit will be arranged at eight weeks intervals.

Sponsors

The Hong Kong Polytechnic University
CollaboratorOTHER
The Queen Elizabeth Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

\- Patient with established Tenckhoff Catheter for at least 3 months with skin healed satisfactorily

Exclusion criteria

* Patient presents with signs and symptoms of exit site infection e.g. purulent discharge, pain, and swab of exit cultured with positive growth. * Patient with unhealed exit site. * Patient currently requires antibiotics * Patient shows sensitive to JUC Spray Dressing or 0.05% Chlorhexidine solution

Design outcomes

Primary

MeasureTime frameDescription
The effectiveness of spray dressing in preventing exit site infectionOn going monitoring for six monthssign and symptom of red, tenderness, hot and discharge.
Prevention of infectionMonitor the exit site for six monthsExit site infection

Secondary

MeasureTime frameDescription
Prevention of skin allergy6 month monitoringSkin allergy

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026