Clinical trial NCT01952964: The Effects of Anti-microbial Spray Dressing in Preventing Tenckhoff Catheter Exit Site Infection for End Stage Renal Failure Patients
Official title: The Effectiveness of a Physical Anti-microbial Spray Dressing in Preventing Tenckhoff Catheter Exit Site Infection for End Stage Renal Failure Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Signs and Symptoms of Exit Site Infection
Physical Damage of the Tenckhoff Catheter
Skin Allery
Keywords: exit site infection
skin allergy
physical damage
Lead sponsor: The Queen Elizabeth Hospital
Sponsor class: OTHER
Collaborators: name: The Hong Kong Polytechnic University
First posted: 2013-09-30
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: The effectiveness of spray dressing in preventing exit site infection
timeFrame: On going monitoring for six months
measure: Prevention of infection
timeFrame: Monitor the exit site for six months
Secondary outcomes:
measure: Prevention of skin allergy
timeFrame: 6 month monitoring
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Renal Unit of Queen Elizabeth Hospital
Study officials:
References:
citation: Davies SJ, Ogg CS, Cameron JS, Poston S, Noble WC. Staphylococcus aureus nasal carriage, exit-site infection and catheter loss in patients treated with continuous ambulatory peritoneal dialysis (CAPD). Perit Dial Int. 1989;9(1):61-4.