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

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

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

Study Overview

• Status: Unknown
• Conditions: Signs and Symptoms of Exit Site Infection; Physical Damage of the Tenckhoff Catheter; Skin Allery
• Intervention / Treatment: Other: JUC spray dressing

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.

• Study Type: Interventional
• Enrollment (Anticipated): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong, 852
    • Recruiting
    • Renal Unit of Queen Elizabeth Hospital
    • Contact: Bonnie TAM, Bachelor and Master; Phone Number: 852-29587461; Email: tamml@ha.org.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: JUC spray dressing

Other: JUC 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The effectiveness of spray dressing in preventing exit site infection	sign and symptom of red, tenderness, hot and discharge.	On going monitoring for six months
Prevention of infection	Exit site infection	Monitor the exit site for six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevention of skin allergy	Skin allergy	6 month monitoring

Collaborators and Investigators

• Sponsor: The Queen Elizabeth Hospital
• Collaborators: The Hong Kong Polytechnic University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (ANTICIPATED): September 1, 2013
• Study Completion (ANTICIPATED): October 1, 2013

Study Registration Dates

• First Submitted: September 25, 2013
• First Submitted That Met QC Criteria: September 25, 2013
• First Posted (ESTIMATE): September 30, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): September 30, 2013
• Last Update Submitted That Met QC Criteria: September 25, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: exit site infection; skin allergy; physical damage
• Additional Relevant MeSH Terms: Pathologic Processes; Kidney Diseases; Urologic Diseases; Disease Attributes; Renal Insufficiency, Chronic; Infections; Communicable Diseases; Kidney Failure, Chronic; Renal Insufficiency
• Other Study ID Numbers: KC/KE-10-0196/ER-3