Clinical Trial Details
— Status: Unknown status
Administrative data
| NCT number |
NCT01952964 |
| Other study ID # |
KC/KE-10-0196/ER-3 |
| Secondary ID |
|
| Status |
Unknown status |
| Phase |
N/A
|
| First received |
September 25, 2013 |
| Last updated |
September 25, 2013 |
| Start date |
March 2011 |
| Est. completion date |
October 2013 |
Study information
| Verified date |
September 2013 |
| Source |
The Queen Elizabeth Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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
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.
