Material and Methods: -

Study Design: Randomised control trial

Study Area: Departments of Urology, AIIMS, Rishikesh

Study period: 17 Months

Study Population- All Adult Patients admitted under Department of Urology in AIIMS Rishikesh advised for Foley insertion will be assessed as per inclusion criteria.   Urine C/S Sample will be Collected during Insertion or with-in first 24 hrs.  Post insertion Urine C/S Report must be sterile for enrolment into the study.  

Sample size calculation:   Dutta M, Mandal AK et.al. conducted a Comparative study at Nehru Hospital, PGIMER Chandigarh revealed that out of a total of 27 samples in Sterile technique group only 4(14.8%) subject developed bacteriuria. whereas in Clean Technique group out of a total of 26 Subjects, 7(26.9) developed bacteriuria. Statistically no Significant differences on the effectiveness of two techniques of catheter care was observed. Respectively the sample size was calculated as 176 in each arm by z Test proportions difference between two independent proportions. A Total Sample size is 352, respectively 176 in each arm.  

Inclusion criteria: -

1.      All patients undergoing Foley catheterization admitted under Dept. of Urology, AIIMS Rishikesh.

2.      Foley catheterization with in past 24 hrs only.

3.      1^st Urine C/S Report must be sterile. (Sample Collected during Insertion/with-in first 24 hrs.)

4.      Age more than 18 years.

5.      Patients who are willing to take part in the study and Ready for consent.

Exclusion criteria: -

1.      Pregnancy

2.      Uncontrolled Diabetes

3.      Patient with CAUTI at time of Admission. (Existing UTI)

4.      Known allergy to Latex

5.      Immunocompromised Patients

Observational Annexure: -

1.      Abbreviations (Annexure: I)

2.      Study Performa (Annexure: II)

3.      Patient information sheet (Annexure: III)                                                                                                                                  

4.      Patient informed consent form (Annexure: IV)

5.      Sterile Indwelling Catheter Care Technique Checklist (Annexure-V)

6.      Clean Indwelling Catheter Care Technique Checklist (Annexure-VI)

7.      Sign and Symptoms for assessment of CAUTI Checklist (Annexure-VII)

8.      Sterile Urinary Catheterization Checklist (Annexure-VIII)

9.      Collection of a Catheter specimen of urine checklist ((Annexure-IX)

10.  Reference study (Annexure-X)

11.  Guidelines favour’s clean gloves for catheter care (Annexure -XI)

12.  Guidelines and Studies Suggesting Routine care by self during Bath (Annexure- XII)

Methodology: -

All patients willing to take part will be recruited from the Departments of Urology of All India Institute of Medical Sciences, Rishikesh. After fulfilling the inclusion and exclusion criteria, patients will be enrolled into the study and a written full informed consent will be taken from each individual explaining the aim and objectives, plan and duration of the study in the language they best understand.

During enrolment, demographic and patient data will be recorded as Single Blind (Participant Blind) Study. Baseline evaluation of each individual will be carried out and would include:

1.      Any Past & Present Medical/ Surgical History

2.      Clinical Characteristics- Size of Foley Catheter (in Fr), Duration of Foley Catheterization (in Days), Place of Catheterization, Fastening Practices, Maintenance of Closed Drainage System, Urinary Retention, Soiled Urinary catheter.

3.      Lab Characteristics- Aerobic culture and sensitivity test for Urine, Urine routine and microscopy examination, Blood Sugar Levels.

4.      Physical examination including VITAL SIGNS.

All Patients admitted in AIIMS Rishikesh under Department of Urology advised for Foley insertion will be assessed as per inclusion criteria. Foley catheterization will be done as per Standard Operating Protocols (Annexure- VIII). During Indwelling Catheterization or with in first 24 hr 1^st sample for Aerobic culture and Sensitivity test for Urine will be collected and sent to lab. (Annexure-IX) Once I^st sample reported as Sterile, Subject will be enrolled in the study by randomised block design using Computer Generated Random number table with provision to choose equal number of participants in each arm. Only the primary investigator can assess the randomization list. If I^st sample is reported as Mixture, repeat sample will be resent earliest. Subject will be allotted by SNOSE Concealment technique into 2 Groups.

·         Group A-Sterile Group will receive Sterile Indwelling Catheter care.(Annexure-V)

·         Group B-Clean Group will receive Clean Indwelling Catheter care.(Annexure- VI)

Catheter care in both groups will be done once in a day preferably in early morning for a Maximum duration of 14 Days and daily monitoring and assessment for CAUTI will be done. (Annexure-VII). The Next Aerobic culture and Sensitivity test for Urine to be send on the day of either PUC removal or on day of patient discharge with PUC or on Day-14^th of Catheterization or if patient becomes symptomatic. CDC criteria for CAUTI such as- Fever more than 38⁰C, Rigors, Pus discharge around the catheter, Positive urine culture, New pain or tenderness in the suprapubic region and New onset confusion or Agitation will be assessed and if symptoms persist sample for Aerobic culture and Sensitivity test for Urine will be sent on the same day. All urine Samples will be analysed for the presences of Significant bacterial count i.e. 10⁵CFU/ml.

Monitoring & Management of Trial Related Adverse Events-  Fever, Rigors, Peri catheter Pus discharge or other symptoms suggestive of CAUTI are some adverse events associated with PUC Insertion.  In this Study Foley care will be provided once, prefer in the early morning. Care will be Verified and daily patient monitoring throughout the trail by Co–investigator will be done as earlier mentioned (Annexure- VII).  As per CDC Guidelines & Literature attached, clean technique is as effective as sterile technique.

Prior to the initiation of Study, Senior Resident’s Nursing officers posted in Urology ward will be oriented to CDC Guideline of sterile catheterization technique for both Gender, Collection of catheter specimen of urine, SOP’s and about both Sterile and Clean Indwelling Catheter care techniques. CAUTI is the endpoint measurement and adverse event will be managed accordingly.

Monitoring & Management of Non-Trial Related Adverse Events-

·         To reduce the overall complications of PUC the strategy should be based on proper catheter insertion technique with strict maintenance protocol, avoidance of unnecessary catheter insertions and prolonged catheterisation.

·         Any severe adverse event will be reported to IEC immediately. In Any Adverse event treatment of the patient and any compensation related issue will be considered as per new Drugs and Clinical Trial Rules (2019).

Statistical Analysis:

1. Descriptive analysis shall be done, Frequency and percentage to show the Distribution of Subject according to the baseline variables.

3. Independent t Test and Chi Square test to determine the association with the selected variables.

5. A p-value < 0.05 will be considered significant, statistical analyses will be done using IBM SPSS for windows.

6. ANOVA will be used to compare means in more than 2 groups.