A Preliminary Report on the Effectiveness of a Physical Anti-Microbial Dressing in Preventing Tenckhoff Catheter (TC) Exit Site Infection (ESI)

Purpose:

According to the ‘Peritoneal Dialysis (PD) First Policy’, around 80% of renal dialysis patients are putting on different mode of PD therapy in Hong Kong.⁽¹⁾ For most patients receiving peritoneal dialysis (PD), there is evidence showing that their satisfaction and quality of life has been increasing. ⁽²⁾  However, the Tenckhoff Catheter (TC) can become a potential source of infection and peritonitis. If exit site infection (ESI) is not well managed it can lead to peritonitis or require removal of the TC ⁽³⁾. Peritonitis is a well known cause of mortality in PD patients ⁽⁴⁾. Consequently, suspending treatment due to access failure may affect patients’ overall health status. The purpose of routine exit site care is to prevent ESI. There is a large volume of information focused on the prevention of ESI, with different approaches being proposed. The practice guidelines and protocols from institutions are varied and have not been adequately evaluated, although large volumes of data have been published on the prevention of ESI ⁽⁵⁾.

Several recent trial studies showed that the application of  JUC Physical antimicrobial Spray Dresssing, has proven to be effective in prevention of lower urinary tract infection ^(6,7), treatment of post-operative infection for oral cancer ⁽⁸⁾,open wound treatment in emergency clinic(Shen & Li, 2006) ^(9,10) and managing radiation-induced acute skin reactions (Li, Lin, Cheng & Li, 2006^)(10). It is also an alternative to antibiotic treatment on wound management for patients with methicillin-resistant Staphylococcus aureus (MRSA) infection ⁽¹¹⁾. JUC spray dressing was developed in China in 2002 and registered as a dressing product by the United States Food and Drug Administration in 2006. It consists of 2% organosilicon quaternary ammonium salt and 98% distilled water, and is safe for application, even for contact with eyes and mucous membranes. The antimicrobial dual sided, nano-film forms a positively charged film that absorbs and neutralizes the negatively charged pathogenic microorganisms. The pathogenic micro-organisms are killed by the electrostatic force created between the positive and negative charges (Li et al, 2011⁾⁽¹²⁾.    

Proper exit site care is of paramount importance in reducing TC associated infection and subsequent catheter loss. In current practice, patients having TC are usually advised to use the traditional antiseptic, 0.05% Gluconate Chlorhexidine in exit site care. In this study, JUC spray was applied to the TC exit site to compare the incidence of ESI with conventional care. In addition to ESI, the existence of skin allergy, catheter damage, and time spent on exit site dressing were examined.

Methods:

The study was carried out through a randomized controlled trial. Seventy four patients were recruited from the renal unit of an acute regional hospital in Hong Kong with 1,700 beds. We reviewed patients whose TC had been in place for at least three months. To compute the sample size, we referred to Li’s paper⁽¹¹⁾ on the effectiveness of JUC spray to prevent ventilator-associated pneumonia. To have 80% power, with 5% alpha, to detect a 27.9% reduction in incidence of bacterial colonization in pharyngeal cavity in experimental group as compare with control group, a sample size of 35 subjects for each group was required. Those patients who did not receive oral or external antibiotics and who had a TC in situ for at least three months were recruited sequentially. Patients presenting with signs and symptoms of exit site infection and poor healing of exit site were excluded. The same type of PD catheters was used for both groups of patients. A total of 78 patients were randomized into study or comparison group using computer generated numbers. Baseline data were collected before randomization. The patients were not blind to the group assignment while the data collector was blind to group allocation. The study group patients used JUC spray dressing while the comparison group used 0.05% Chlorexidine dressing daily for standard wound care. Skin tests with JUC spray and Chlorhexidine were carried out prior to intervention for both group patients. Coaching was provided by the nurses to ensure that the patients were able to perform the procedures correctly. The study team called the patients on the first three days and they were instructed to report any abnormalities they noticed to the nurses, such as signs and symptoms of infection, skin allergy, and damage of TC. They were treated with antibiotics if diagnosed for ESI and were continued with the study after treatment. Clinical efficacy was assessed for a period of six months after implementation of intervention.  According to the study unit protocol, the presence of two out of three equivocal signs and symptoms of exit site infection were diagnosed as acute exit site infection, which included redness around the exit site, with 3-4 mm measurement from the edge and purulent discharge.⁽¹³⁾

Results:

A total of 74 patients, with 37 from the study and comparison groups were included in the final analysis. The patients in the study group were significantly younger than the comparison group. Other demographic and clinical information, such as gender, presence of diabetes, abnormal albumin level, and previous history of ESI were examined and no significant difference was found between the two groups. See Table 1 for details. Table 1. Demographic Data and Clinical Characteristics of the Study Population (n=74)

	Study group (n=37)	Comparison group (n=37)	p-value
Age	56 (47.5 – 74)	72 (60 – 75.5)	*0.011
Duration of TC insertion (month)	25 (11 – 46)	17 (10.5 – 54.3)	0.94
Gender  Male  Female	18 (48.6%) 19 (51.4%)	14 (37.8%) 23 (62.2%)	0.348
Diabetes  Yes  No	10 (27%) 27 (73%)	14 (37.8%) 23 (62.2%)	0.321
Normal Albumin  Yes  No	14 (37.8%) 23 (62.2%)	21 (56.8%) 16 (43.2%)	0.103
Previous ESI  Yes  No	16 (43.2%) 21 (56.8%)	15 (40.5%) 22 (59.5%)	0.814

*p<0.05

ESI developed in two patients (5.4%) in the study group and nine patients (24.3%) in the comparison group. The results was significant (p=0.022) for the two groups. Amongst the nine patients of the comparison group, ESI occurred twice during the six month period in two patients. No allergic reactions were reported for either group of patients. It was considered important to report whether the new treatment caused damage to the TC. One patient in the comparison group reported damage to the catheter as confirmed by the physician. Time spent on TC dressing was significantly shorter in the study group (median: two minutes) than in the comparison group (median: ten minutes). The study group patients were all satisfied with the new treatment. The cost for Chlorexidine dressing was HK$3.00 (equivalent to US$0.38) per dressing, while the cost for JUC spray was HK$0.5 per application. See Table 2 for results.  

Table 2. Results at six months post-intervention

	Study group (n=37)	Comparison group (n=37)	p-value
Allergy  No	37 (100%)	37 (100%)	----
Exit site infection  Yes  No	2 (5.4%) 35 (94.6%)	9 (24.3%) 30 (75.7%)	*0.022
TC damage  Yes   No	0 (0%) 37 (100%)	1 (2.7%) 36 (100%)	1
Time used for dressing (minutes)	2 (1 – 8)	10 (2 – 15)	*<0.001
Treatment cost (HK$)	0.5	3.00

*p<0.05

Eleven samples were taken from the infected exit sites for bacteria analysis. Staphlococci, Diphtheroid bacillus, Pseudomonas and Streptococcus Salivalir were found mostly in the wounds of the comparison group.  While Acinetobacter Species and the Pseudomonas species were found in the JUC group.    

Discussion :Proper exit site care is of paramount importance to reducing TC-associated infections and subsequent catheter losses. Adequate immobilization of the catheter and daily exit site care are the significant issues to be investigated. Our study demonstrated that JUC spray can replace traditional disinfectants for exit site care as it does not cause adverse effects and can counter the problem of drug resistance. The results demonstrated that the incidence of ESI in the treatment group was significantly lower than that in the comparison group. Once JUC is sprayed on the skin surface, it dries almost instantly, thus reducing the time, effort, and discomfort of exit site care. Patients enjoy better quality of life, as daily exit site care is no longer a burden. However, our results on time savings need to be interpreted with caution as patients in the study group were significantly younger; and the younger patients may perform faster in daily activities than older patients, depending on the nature and severity of their respective conditions. Antibiotics resistance may be the result of extensive use of antibiotics for the end stage renal failure patients with compromised immune systems. The use of JUC spray can play an important role in exit site management for patients who may  sensitive to Chlorhexidine and/or antibacterial agents. The use of JUC spray to replace traditional dressing materials and methods could reduce the financial burden on Hong Kong’s health care system by reducing medication expenses.

Conclusion:

TC is the life line of PD therapy patient.  TC care at least daily is highly recommended and  JUC spray is a safe, simple and sustainable (3S) dressing alternative to the traditional TC care. Further studies are required using a larger sample size to investigate and fully understand the applicability of JUC in exit site care in hospital renal units and the community setting.