See discussions, stats, and author profiles for this publication at: https://www.researchgate.

net/publication/353493823

Non-randomized Clinical Trial of In-house Silver-Coated Foley’s Catheter

Reduces Urinary Tract Infections—a Low-Cost Innovation

Article in Indian Journal of Surgery · July 2021

DOI: 10.1007/s12262-021-03027-2

CITATION READS

1 182

5 authors, including:

Tejaswini Vallabha Vikram Sindagikar

BLDE(Deemed to be University) BLDE University
24 PUBLICATIONS 129 CITATIONS 20 PUBLICATIONS 130 CITATIONS

SEE PROFILE SEE PROFILE

Girish Kullolli
BLDE University
12 PUBLICATIONS 20 CITATIONS

SEE PROFILE

All content following this page was uploaded by Tejaswini Vallabha on 31 July 2021.

The user has requested enhancement of the downloaded file.

Indian Journal of Surgery
https://doi.org/10.1007/s12262-021-03027-2

SURGICAL TECHNIQUES AND INNOVATIONS

Non‑randomized Clinical Trial of In‑house Silver‑Coated Foley’s

Catheter Reduces Urinary Tract Infections—a Low‑Cost Innovation
Tejaswini Vallabha1 · Hanumanth Ammanna1 · Vikram Sindgikar1 · Girish Kullolli1 · Aparajita Saha1

Received: 1 January 2021 / Accepted: 3 July 2021

© Association of Surgeons of India 2021

Abstract
Catheter-associated urinary tract infections account for 80% of hospital-related urinary tract infections. Attempts are being
made to improvise catheters to reduce the infective burden. A non-randomized clinical trial was conducted on two hundred
and forty patients who required catheterization. The aim was to assess the efficacy of silver ion–impregnated Foley catheters
in reducing urinary tract infections. They were divided equally with 120 patients in each group. The control group received
standard Foley catheter insertion and patients in the study group received in-house-prepared silver ion–impregnated catheters.
Urine was examined for the presence of pus cells on days 1, 3, and 7. Culture and sensitivity were carried out on days 1, 3,
and 7. Though the initial results were similar in both groups, there was a significant reduction in the number of pus cells in
urine and a decrease in positive cultures on day 7 (P = 0.0277 and P = 0.0497), respectively suggesting the efficacy of silver
ion impregnation. This is a simple and easy-to-perform technique with potential for routine use in the future with adequate
validation. Routine use minimizes antibiotic usage due to reduced incidence of urinary tract infections and hospital expenses.

Keywords Catheter-associated urinary tract infections · CAUTI · Silver-coated urinary catheters · Hospital-acquired
infections · Silver ion impregnation

Introduction and about 80% of them are caused by instrumentation of the

urinary tract [3, 4]. Though mortality due to CAUTI is less
An infection is considered a healthcare-associated infec- than 5%, it leads to prolonged hospitalization and increases
tion (HAI) “if the date of the event of National Healthcare cost and the development of multidrug-resistant strains.
Safety Network (NHSN) site-specific infection criterion Urinary catheterization is part of standard care for man-
occurs on or after the 3rd calendar day of admission to an agement for many medical or surgical conditions. Attempts
inpatient location where the day of admission is calendar are being made to improvise the quality of catheters towards
day” [1]. Hospital-acquired infections (HAI) include central reducing the infective burden. One of the methods is to coat
line–associated infections, catheter-associated urinary tract the catheter with a material that either reduces or prevents
infections, ventilator-associated pneumonia, and surgical infection. Silver has been known to have antimicrobial prop-
site infections [1]. Developing countries have 10% hospital- erties. AgO impregnation over conventional Foley catheter
acquired infections leading to extended hospital stay and has the potential to reduce urinary tract infections and in
financial burden. Urinary tract infections (UTIs) account turn reduces stay and cost of care. There are very few stud-
for 12.9% of HAI [2]. The CDC defines catheter-associated ies done in our country where the efficacy of silver as an
urinary tract infection (CAUTI) in those patients as having antimicrobial agent coating is assessed [4, 5].
“an indwelling catheter for 7 or 8 h.” UTIs are the most Various agents like Bactigaurd-coated Foley catheter
common HAI in acute care setup, almost amounting to 30%, (gold-silver palladium alloy, hydrogel-coated catheters,
antibiotic-coated catheters) have all been tried with variable
success rates. However, experience related to those is limited
* Tejaswini Vallabha
tejaswini.vallabha@bldedu.ac.in; aniketankv@yahoo.co.in [6]. Production-related issues, cost, etc. have been the issues
for routine use. Simple, cost-effective impregnation is nec-
1
Department of Surgery, BLDE DU’s Shri.B.M.Patil essary for widespread use. Hence, a variety of attempts are
Medical College & Research Centre, Solapur Road, made in preparing such a catheter, used in clinical trials to
Karnataka 586103 Vijayapura, India

13
Vol.:(0123456789)
 Indian Journal of Surgery

assess the infection reduction rate [4, 7]. One or two varie- 3 days were included. Patients with renal diseases, pre-
ties of silver-coated urinary catheters are available, but the existing catheters, who underwent invasive urosurgery, prior
costs are significantly high and not easily available in the positive urine culture, and sterile pyuria were excluded.
market. Currently, in the USA, the available silver hydro- Catheterization was done by surgery residents as per
gel–coated Foleys’ catheters are very costly [8]. standard practice, i.e., cleaning and retracting prepuce/vulva
Keeping in mind the limitations of conventional Foley with povidone-iodine and insertion with aseptic precautions.
catheters (Latex), this study was taken up to assess the After ensuring the catheter in situ, few milliliters of urine
effectiveness of silver-impregnated latex Foley catheters in were drained and the urine samples were collected directly
reducing CAUTI and assess the efficacy of the silver oxide and sent for microscopy and culture sensitivity. Later, sam-
impregnation method adopted by Nandakumar et al. [4]. The ples were collected on day 3 and day 7 directly by aspirating
method is easy and feasible and is a low-cost innovation. the catheter for the presence of pus cells and culture sensitiv-
ity. Patients were observed for clinical symptoms of UTI and
documented. Pyuria was considered significant if pus cells
Patients and Methods were more than 10 per hpf. Urine cultures were considered
significant if organisms were more than ­105 (Chart 1).
A non-randomized clinical trial was conducted on 240 The results were recorded in a Microsoft excel sheet and
patients catheterized for various conditions after obtaining analysed with appropriate statistical methods. A P value
written informed consent and Institutional Ethics Committee of < 0.05 was considered significant.
clearance. They were divided into study and control groups.
The technology applied is patented; hence, written permis-
sion was taken from the corresponding author [4].
Results
Method of Silver Oxide Impregnation
A total of 240 patients with 141 men and 99 women were
The materials used were latex Foley catheters, toluene or included. The study group had 66 men and 54 women
methylbenzene, silver nitrate, and formamide. The com- patients. The control group had 75 men and 45 women.
mercially available latex Foley catheter was first dipped Age ranged from 18 to 70 years. Maximum patients (53 and
in toluene for 30 s. Silver nitrate powder was mixed (1 g/ 67) were in the age group of 30–39 and 40–49 years’ range
catheter) with formamide solution and catheters were placed respectively. The mean age of the study group was 47.63 SD
in it. This solution was heated in a temperature-controlled 15.04 and the control group 47.73 SD 13.07. Both groups
water bath at about 70–80 degrees centigrade for 15 min. were comparable demographically. Indications for urinary
After cooling, the catheters were washed in distilled water catheterization are tabulated in Table 1.
to remove excess formamide and dried. Later, these dried Urine routine examination and cultures were done on day
catheters were sterilized using ethylene oxide sterilization 1, day 3, and day 7 of catheterization.
for 48 h. Then they were used on patients (Fig. 1a and b). It was observed that the presence of pus cells on days
Patients with negative urine culture on insertion of the 1 and 3 was similar in both groups with a P value of 0.77
catheter and who needed catheterization for more than and 0.64 respectively. Pus cells were significantly low in

Fig. 1  a Regular Foley catheter.

b Silver-impregnated Foley’s
catheter

a Regular Foley’s catheter b Silver impregnated Foley’s catheter

13
Indian Journal of Surgery

Chart. 1  Flowchart of patients OBJECTIVE:Assess efficacy of silver

and methods coating on Foley’s catheters in
reducing Catheter associated urinary
tract infections

INCLUSION CRITERIA EXCLUSION CRITERIA

catheterization required for more than 3 preexisting catheters, invasive urosurgery sterile
days Day one urine pus cells normal and pyuria,positive 1st culture ,medical renal diseases
culture should be sterile

STUDY GROUP (120) CONTROL GROUP (120)

Silver impregnated latex Foley’s catheter Standard Latex Foley’s Catheter

-Silver impregnated Catheter insertion -Standard Foley’s catheter insertion.

-Urine for pus cells and culture sensitivity sent -Urine for pus cells and culture sensitivity sent
immediately immediately

-Repeated on day 3 and day 7 -Repeated on day 3 and day 7

Results analyzed

Table 1  Indications for Sl. no Indications Study Control Total

catheterization
1 Split thickness skin grafting in the lower limbs or surround- 22 14 36
ing areas where urine contamination was expected
2 Necrotising fasciitis 17 18 35
3 Fracture of lower limb 18 17 35
4 Exploratory laparotomy 8 17 25
5 Deep venous thrombosis 13 15 25
6 Resection anastomosis of small bowel 11 7 18
7 Quadriplegia/hemiplegia 11 5 16
8 Blunt trauma abdomen 7 8 15
9 Sub-acute intestinal obstruction 4 7 11
10 Bedsores 2 7 9
11 Neurogenic bladder 3 3 6
12 Sepsis 3 2 5
13 Thoracotomy 1 3 4

the silver-coated catheter group on day 7 with a P value of silver-impregnated group had 13 cultures positive on day
0.0277 (Table 2). 3. The number increased to 33 in the silver-coated catheter
Urine cultures were repeated on day 3, day 7, and weekly group and 47 in the plain catheter on day 7. Though similar
until the catheter was removed. The duration considered for in the initial results, there was a significant increase in the
the study was 7 days. Both the plain catheter group and the number of positive cultures (47) after 7 days of insertion in

13
 Indian Journal of Surgery

Table 2  Details of results and comparison of the incidence of pyuria and positive cultures in both groups
Siver oxide–coating group Plain latex group P value
Pus cells (no of patients) % Positive % Pus Cells (no of patients) % Positive % Pus cells Positive
urine Urine Urine
culture culture culture

Day 1 7 5.8 - 9 7.5 - 0.77

Day 3 26 21.6 13 10.8 29 24.1 13 10.8 0.64 1.1O
Day 7 47 39.1 33 27.5 64 53.3 47 39.1 0.02 0.049
Sympto- No of patients % No of patients % P value
matic
CAUTI
12 10 16 13.3 0.042
Male 66 55 75 62 0.23
Female 54 45 48 37

< 0.05 is significant p value

the plain catheter group compared to the silver-impregnated many advantages and often a source of infection. CAUTI
catheters, with 33 positive cultures and a significant P value has been ranked number 2 in the incidence of HAI [9].
of 0.049 (Chart 2). With extensive use of bladder catheterization, related com-
The average cost of impregnating silver ion wasRs plications and morbidity have increased too. The risk of
100 + catheter cost, i.e., 80 + 100 = 180/- with a cost price developing pyuria in a patient with an indwelling catheter
of the standard catheter being Rs 80/-. This impregnation is approximately 3 to 10% per day. Among them, 10 to
was possible in-house in the central research laboratory 25% develop symptoms of local infection and about 1 to
with basic facilities for temperature-controlled water bath 4% develop bacteremia [10]. Various studies emphasize
and ETO sterilization facilities. that even if other co-morbidities are taken care of, there is
three times increase in mortality and morbidity associated
with urinary catheter–related infections [11]. Access to
Discussion the sterile urinary tract to the exterior through a catheter
enhances susceptibility to infections. Regular cleaning and
CAUTI has been one of the important reasons for following aseptic precautions in handling catheters reduce
increased morbidity, hospital stay, and overall cost. It the chances of CAUTI. But multiple hands, prolonged
can become the cause of mortality if sepsis is significant. duration of catheterization, and contamination from the
Routine urinary catheterization for various indications has genital tract, perineal organisms, and general condition

Study Group 0
6.3 Control Group 4.3
12.7 2.1 6.3 2.8 0 5.7 18.8
17 21.7
23.4 7.2

27.6 5.7

33.3
C. ALBICANS
C. ALBICANS C. FRUEIDI C. FRUEIDI
C. NON ALBICANS, S. AUREUS C. NON ALBICANS,
E. COLI E. SAPROPHYTICUS S. AUREUS
P. AUREUGINOSA K. PNEUMONIA E. COLI
Proteus E. SAPROPHYTICUS

Chart. 2  Organisms isolated

13
Indian Journal of Surgery

of the patient all predispose to CAUTI. Hence, this led would be 1400 × 392 = 548,800 for the silver oxide catheter
to attempts in modifying the catheter quality, use of dif- group and 1400 × 533 = 746,200 for the simple latex catheter
ferent materials, and attempting coating of catheters to group.
reduce contamination. At present, all are in trials [4, 7]. Total cost burden in both the groups:
The standard latex catheters are soft, easily usable, and
cost-effective. Latex catheters, in favorable conditions, can Silver oxide catheter group—Rs 180,000 + 548,800 = Rs
develop biofilms which in turn are a source for chronic 728,800/-
infections [12, 13]. Silver ion is known to have bactericidal Simple latex catheter group—Rs80000 + 746,200 = Rs
effects and biocompatibility and is used as a topical agent 826,200/-
in other situations like burns wounds. Following impreg- The anticpated difference—Rs
nation of silver on catheters, there is a migration of silver 826,200 − 728,800 = Rs97400/-
ions which has antimicrobial effects and is not toxic to
patients [4]. Since the early 1990s, research has focused The cost reduction per 1000 catheterization will be
on different anti-infective catheter-coating materials, but around one lakh or Rs 97,400/-.
results have been generally inconclusive [7]. Bactiguard-
coated Foley catheters, an essential noble metal alloy and
hydrogel-coated catheter, have been introduced to slow Conclusion
bacterial colonization [6, 7]. In the early 2000s, a ran-
domized crossover study [12, 13] demonstrated that the This study, an open-label non-randomized non-practice
risk of UTI could be decreased by 21% in the wards when that changes usual unsupervised urinary catheterization of
a noble metal alloy catheter was used instead of a con- self-retaining Foley’s catheter, if simply impregnated with
ventional catheter. But access to such catheters which are silver, showed a reduction in CAUTI when catheterization
easily prepared, available, and cost-effective has not been was required for a week or more. There was no difference
possible. Silver ion–based hydrogels are now increasingly in short-duration catheterization. This low-cost innovation
being used as a surface coating for wounds to reduce bio- can reduce the overall cost of hospitalization and financial
film development [14, 15]. With the technique proposed burden to hospitals cumulatively.
here, silver ion coating can be easily impregnated to the
existing available latex Foley catheters without an increase
in toxicity or reduced quality. Though the results regard- Declarations
ing the number of pus cells in the urine and urine cultures
were similar in both groups during the initial period of Conflict of Interest The authors declare no competing interests.
catheterization, there was a significant difference in the
incidence of pyuria and positive cultures in the samples
obtained on day 7, suggesting its effectiveness in patients References
who need prolonged catheterization. Though there are
variable results, there is risk reduction [12, 13]. Reviews 1. CDC. National Healthcare Safety Network (NHSN)- Patient
suggest there is an emerging tilt towards the benefit of Safety Component Manual. Jan 2020. Available at: https://​www.​
cdc.​gov/​nhsn/​pdfs/​pscma​nual/​pcsma​nual_​curre​nt.​pdf. Accessed
using silver alloy–coated catheters [16], but clear conclu-
16 Nov 2020.
sions are lacking. The overall clinical implications will 2. Monegro AF, Regunath H (2018) Hospital acquired infections
be significant as any reduction in the incidence of CAUTI [Internet]. StatPearls [Internet]. U.S. National Library of Medi-
will reduce morbidity and mortality cost-effectiveness in cine. Available at: https://​www.​ncbi.​nlm.​nih.​gov/​books/​NBK44​
1857/. Accessed 18 Dec 2020
the long run.
3. Sangamithra V, Sneka, Praveen Shabana and Manonmoney. Inci-
dence of catheter associated urinary tract infection in medical
ICU in a tertiary care hospital. Int J Curr Microbiol App Sci 2017;
Presumptive Cost Analysis 6:662–669
4. Nandkumar AM, Ranjit MC, Pradeep Kumar SS, Hari PR,
Ramesh P, Sreenivasan K (2010) Antimicrobial silver oxide incor-
With the present results, the anticipated incidence of posi- porated urinary catheters for infection resistance. Trends Biomater
tive urine cultures for 1000 patients on day 7 would be silver Artif Organs 24:156–164
oxide catheter group—Rs 392/1000 and simple latex cath- 5. William Rl, Doherty PJ, Venice DG Grasgoff GJ, Williams DF.
Biocompatibility of silver. Critical reviews in Biocompatibility.
eter group—Rs 533/1000. Considering the cost of antibiotic
1989; 5: 221 – 223
therapy for one patient at Rs 140/-0 (considering the average 6. Chung PH, Wong CW, Lai CK, Siu HK, Tsang DN, Yeung
cost of standard antibiotic ceftriaxone as protocol with Rs KY et al (2017) A prospective interventional study to examine
50/ per dose for 7 days’ therapy twice a day), the expenses the effect of a silver alloy and hydrogel-coated catheter on the

13
 Indian Journal of Surgery

incidence of catheter-associated urinary tract infection. Hong 13. Karchmer TB, Giannetta ET, Muto CA, Strain BA, Farr BM
Kong Med J 23:239–245 (2000) A randomized crossover study of silver-coated uri-
7. Riley DK, Classen DC, Stevens LE, Burke JP (1995) A large nary catheters in hospitalized patients. Arch Intern Med
randomized clinical trial of a silver-impregnated urinary catheter: 160:3294–3298
lack of efficacy and staphylococcal super-infection. Am J Med 14. Trooskin S.Z, Donetz AP et al. Prevention of catheter sepsis by
98:349–356 antibiotic bonding. Surgery 1985; 547–551.
8. [INTERNET] https://​www.​shopc​athet​ers.​com/p-​kenda​ll-​two-​ 15. Van de Belt H, Neut D, Uges DRA, Schenk W, Van Horn JR
way-d​ over-s​ ilver-c​ oated-1​ 00-p​ ercen​ t-s​ ilico​ ne-f​ oley-c​ athet​ er-w
​ ith-​ (2000) Surface roughness, porosity and wettability of gentamicin
30cc-​ballo​on.​html. Accessed 20 Dec 2020 loaded bone cements and their antibiotic release”. Biomaterials
9. Pérez E, Uyan B, Dzubay DP et al (2017) Catheter-associated 21:1981–87
urinary tract infections: challenges and opportunities for the appli- 16. Beattie M (2011) Taylor J Silver alloy vs uncoated urinary cath-
cation of systems engineering. Health Syst 6:68–76. https://​doi.​ eters : a systematic review of the literature. J Clin Nurs 20(15–
org/​10.​1057/​s41306-​016-​0017-0 16):2098–2108. https:// ​ d oi. ​ o rg/ ​ 1 0. ​ 1 111/j. ​ 1 365- ​ 2 702. ​ 2 010.​
10. Saint S, Elmore JG, Sullivan SD, Emerson SS, Koepsell TD 03561.x
(1998) The efficacy of silver alloy-coated urinary catheters in
preventing urinary tract infection: a meta-analysis. Am J Med Publisher’s note Springer Nature remains neutral with regard to
105:236–241 jurisdictional claims in published maps and institutional affiliations.
11. Platt R, Polk BF, Murdock B, Rosner B (1982) Mortality asso-
ciated with nosocomial urinary tract infection. N Engl J Med
307:637–642
12. An YH, Friedman RJ (1998) Concise review of mechanisms of
bacterial adhesion to biomaterial surfaces. J Biomed Mater Res
(Appl Biomater) 43:338–348

13

View publication stats