Reducing Urinary Tract Infection Rates Using a Controlled Aseptic Protocol for Catheter Insertion

• Sponsor: University of Colorado, Denver (Other)
• Overall Status: Completed
• CT.gov ID: NCT03101371
• Collaborator: (none)
• Enrollment: 99
• Location: 1
• Arms: 2
• Actual Duration (Months): 16.2
• Patients Per Site Per Month: 6.1

Study Details

Study Description

Brief Summary

Urinary Tract Infection (UTI) complications following catheter use in surgical patients remains high. Using an aseptic protocol has been shown to drastically reduce UTI incidence by 50%. Reducing UTIs will prevent extended hospital stays, readmission, and antibiotic use associated with this complication and improve cost-effectiveness of care. The investigators hypothesize that they can reduce the incidence of UTIs after catheter placement with the implementation of a Quality Improvement (QI) protocol to prevent excess exposure to the environment exposure of the catheter before, during and after insertion.

Condition or Disease	Intervention/Treatment	Phase
Urinary Tract Infections; Catheter Infection; Catheter-Related Infections	Drug: Catheter insertion with Povidone Iodine; Procedure: Standard of care catheter insertion	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 99 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Patients with normal urinary analysis (UA) pre-surgery will be randomized 1:1 to one of two arms prior to surgery: Aseptic protocol for catheter insertion using Povidone Iodine treated catheter and maintaining plastic sleeve on catheter or Standard of care (SOC) catheter insertion in which catheter is inserted right out of package/non-treated catheter.Patients with normal urinary analysis (UA) pre-surgery will be randomized 1:1 to one of two arms prior to surgery:Aseptic protocol for catheter insertion using Povidone Iodine treated catheter and maintaining plastic sleeve on catheter or Standard of care (SOC) catheter insertion in which catheter is inserted right out of package/non-treated catheter.
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Reducing Urinary Tract Infection Rates Using a Controlled Aseptic Protocol for Catheter Insertion
• Actual Study Start Date: Oct 10, 2017
• Actual Primary Completion Date: Feb 15, 2019
• Actual Study Completion Date: Feb 15, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard of care catheter insertion Standard of care catheter insertion in which catheter is inserted right out of package/non-treated catheter.	Procedure: Standard of care catheter insertion; Catheter inserted right out of package.
Experimental: Aseptic protocol for catheter insertion Aseptic protocol for catheter insertion using Povidone Iodine treated catheter and maintaining plastic sleeve on catheter	Drug: Catheter insertion with Povidone Iodine; The catheter will be treated with Povidone Iodine prior to insertion.; Other Names: Aseptic protocol for catheter insertion using Povidone Iodine treated catheter

Outcome Measures

Primary Outcome Measures

1. Number of Participants With a Catheter Associated Urinary Tract Infection (CAUTI) [Within 14 +/- 2 days post-surgery]

   Participants were monitored for up to 14 days. This was assessed with a rapid urine analysis (UA) test. A urinary tract infection was defined as >10^5 bacterial colony forming units per ML on urine culture regardless of symptoms. This is the number of participants who had at least one CAUTI during the time of observation.

Secondary Outcome Measures

1. Number of Participants Who Received the "Fill and Pull" Versus the "Pull and Void" Method of Catheter Discontinuation [Day 14 (+/- 2 days)]

   Participants were monitored for up to 2 weeks. This is the number of participants who received one method versus the other for catheter discontinuation.

2. Average Patient Satisfaction [Day14 (+/- 2 days)]

   Participants were monitored at 2 weeks. This was assessed using a Likert scale questionnaire (1 = not at all satisfied, 10 = extremely satisfied). Average patient satisfaction with the catheter was assessed.

3. Number of Participants With Extended Hospital Stay Due to a Urinary Tract Infection (UTI) [14 days (+/- 2 days) from surgery]

   Participants were monitored for up to 14 days. This is the number of participants who had a UTI in the hospital, extending their stay for more than seven days.

4. Number of Participants With Closed Drainage System Disrupted During Placement of Catheter [Day 1 post op]

   Participants were monitored post surgery until time of discharge. This is the number of participants who had the closed drainage system disrupted during placement of catheter for back fill of the bladder during surgery.

5. Number of Participants That Were Readmitted, Had Additional Clinic Visits or Went to the Emergency Department (ED) for Any Reason [Day 14 (+/- 2 days)]

   Participants were monitored up to two weeks. This is the number of participants who had at least one readmission or emergency room visit during the time of observation.

6. Number of Patients That Used Antibiotics at the Time of Surgery and Post-surgery [Day 14 (+/- 2 days)]

   Participants were monitored for up to 2 weeks. This is the number of participants that used any antibiotic during surgery and post-surgery.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 89 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. women 18-89 years of age

2. admitted for surgery lasting >1 hour and requiring urinary catheter,

3. have normal urine analysis within 24 hours pre-surgery, and

4. able to provide informed consent.

Exclusion Criteria:

1. currently on dialysis,

2. chronic urinary infection,

3. hyperthyroidism,

4. current infection,

5. a history of allergy or sensitivity to iodine.

6. women who are pregnant or breast feeding

7. men due to their lower incidence of UTIs compared to the female population.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Colorado Denver	Aurora	Colorado	United States	80045

Sponsors and Collaborators

• University of Colorado, Denver

Investigators

• Principal Investigator: Saketh Guntupalli, MD, University of Colorado, Denver

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 21, 2019
• Informed Consent Form - Mar 1, 2018

More Information

Publications

None provided.

• Responsible Party: University of Colorado, Denver
• ClinicalTrials.gov Identifier: NCT03101371
• Other Study ID Numbers: 16-1096
• First Posted: Apr 5, 2017
• Last Update Posted: Mar 10, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections; Catheter-Related Infections; Iodine; Povidone-Iodine; Povidone

Study Results

Participant Flow

Recruitment Details	A single-site randomized controlled trial, conducted at the University of Colorado Hospital, enrolled women beginning October 2017 and ended February 2019.

Arm/Group Title	Standard of Care Protocol Catheter Insertion	Aseptic Protocol for Catheter Insertion
Arm/Group Description	Standard of care catheter insertion in which catheter is inserted right out of package/non-treated catheter. Standard of care catheter insertion: Catheter inserted right out of package.	Aseptic protocol for catheter insertion using Povidone Iodine treated catheter and maintaining plastic sleeve on catheter Catheter insertion with Povidone Iodine: The catheter will be treated with Povidone Iodine prior to insertion.
Period Title: Overall Study
STARTED	48	51
COMPLETED	45	45
NOT COMPLETED	3	6

Baseline Characteristics

Arm/Group Title	Standard of Care Protocol Catheter Insertion	Aseptic Protocol for Catheter Insertion	Total
Arm/Group Description	Standard of care catheter insertion in which catheter is inserted right out of package/non-treated catheter. Standard of care catheter insertion: Catheter inserted right out of package.	Aseptic protocol for catheter insertion using Povidone Iodine treated catheter and maintaining plastic sleeve on catheter Catheter insertion with Povidone Iodine: The catheter will be treated with Povidone Iodine prior to insertion.	Total of all reporting groups
Overall Participants	45	45	90
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	56.0 (13.37)	56.5 (14.27)	56.2 (13.75)
Sex: Female, Male (Count of Participants)
Female	45 100%	45 100%	90 100%
Male	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
White Non-Hispanic	40 88.9%	36 80%	76 84.4%
Hispanic	2 4.4%	6 13.3%	8 8.9%
American Indian or Alaskan Native	1 2.2%	0 0%	1 1.1%
African American	1 2.2%	1 2.2%	2 2.2%
Asian	1 2.2%	2 4.4%	3 3.3%
Menopause status (Count of Participants)
Pre-menopausal	15 33.3%	15 33.3%	30 33.3%
Post-menopausal	30 66.7%	30 66.7%	60 66.7%
Smoking status (Count of Participants)
Current	5 11.1%	6 13.3%	11 12.2%
Former	12 26.7%	17 37.8%	29 32.2%
Never	28 62.2%	22 48.9%	50 55.6%
Diabetes (Count of Participants)
Count of Participants [Participants]	4 8.9%	6 13.3%	10 11.1%
Hypertension (Count of Participants)
Count of Participants [Participants]	16 35.6%	18 40%	34 37.8%
Cancer Diagnosis (Count of Participants)
Uterine Cancer	10 22.2%	10 22.2%	20 22.2%
Ovarian Cancer	26 57.8%	24 53.3%	50 55.6%
Cervical	2 4.4%	2 4.4%	4 4.4%
Benign	5 11.1%	8 17.8%	13 14.4%
Other	2 4.4%	1 2.2%	3 3.3%
Primary Surgery (Count of Participants)
Total Abdominal Hysterectomy +/- BSO/USO	23 51.1%	28 62.2%	51 56.7%
Radical Hysterectomy	2 4.4%	0 0%	2 2.2%
Bowel resection	4 8.9%	2 4.4%	6 6.7%
Omentectomy	6 13.3%	4 8.9%	10 11.1%
Bilateral/unilateral salpingo-oophorectomy	3 6.7%	5 11.1%	8 8.9%
Lymph Node Dissection	1 2.2%	0 0%	1 1.1%
Other	6 13.3%	6 13.3%	12 13.3%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With a Catheter Associated Urinary Tract Infection (CAUTI)
Description	Participants were monitored for up to 14 days. This was assessed with a rapid urine analysis (UA) test. A urinary tract infection was defined as >10^5 bacterial colony forming units per ML on urine culture regardless of symptoms. This is the number of participants who had at least one CAUTI during the time of observation.
Time Frame	Within 14 +/- 2 days post-surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard of Care Protocol Catheter Insertion	Aseptic Protocol for Catheter Insertion
Arm/Group Description	Standard of care catheter insertion in which catheter is inserted right out of package/non-treated catheter. Standard of care catheter insertion: Catheter inserted right out of package.	Aseptic protocol for catheter insertion using Povidone Iodine treated catheter and maintaining plastic sleeve on catheter Catheter insertion with Povidone Iodine: The catheter will be treated with Povidone Iodine prior to insertion.
Measure Participants	45	45
Count of Participants [Participants]	7 15.6%	6 13.3%

2. Secondary Outcome

Title	Number of Participants Who Received the "Fill and Pull" Versus the "Pull and Void" Method of Catheter Discontinuation
Description	Participants were monitored for up to 2 weeks. This is the number of participants who received one method versus the other for catheter discontinuation.
Time Frame	Day 14 (+/- 2 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard of Care Protocol Catheter Insertion	Aseptic Protocol for Catheter Insertion
Arm/Group Description	Standard of care catheter insertion in which catheter is inserted right out of package/non-treated catheter. Standard of care catheter insertion: Catheter inserted right out of package.	Aseptic protocol for catheter insertion using Povidone Iodine treated catheter and maintaining plastic sleeve on catheter Catheter insertion with Povidone Iodine: The catheter will be treated with Povidone Iodine prior to insertion.
Measure Participants	45	45
Fill and pull	38 84.4%	40 88.9%
Pull and void	7 15.6%	5 11.1%

3. Secondary Outcome

Title	Average Patient Satisfaction
Description	Participants were monitored at 2 weeks. This was assessed using a Likert scale questionnaire (1 = not at all satisfied, 10 = extremely satisfied). Average patient satisfaction with the catheter was assessed.
Time Frame	Day14 (+/- 2 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard of Care Protocol Catheter Insertion	Aseptic Protocol for Catheter Insertion
Arm/Group Description	Standard of care catheter insertion in which catheter is inserted right out of package/non-treated catheter. Standard of care catheter insertion: Catheter inserted right out of package.	Aseptic protocol for catheter insertion using Povidone Iodine treated catheter and maintaining plastic sleeve on catheter Catheter insertion with Povidone Iodine: The catheter will be treated with Povidone Iodine prior to insertion.
Measure Participants	45	45
Mean (Standard Deviation) [score on a scale]	8.17 (2.39)	8.6 (2.04)

4. Secondary Outcome

Title	Number of Participants With Extended Hospital Stay Due to a Urinary Tract Infection (UTI)
Description	Participants were monitored for up to 14 days. This is the number of participants who had a UTI in the hospital, extending their stay for more than seven days.
Time Frame	14 days (+/- 2 days) from surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard of Care Protocol Catheter Insertion	Aseptic Protocol for Catheter Insertion
Arm/Group Description	Standard of care catheter insertion in which catheter is inserted right out of package/non-treated catheter. Standard of care catheter insertion: Catheter inserted right out of package.	Aseptic protocol for catheter insertion using Povidone Iodine treated catheter and maintaining plastic sleeve on catheter Catheter insertion with Povidone Iodine: The catheter will be treated with Povidone Iodine prior to insertion.
Measure Participants	45	45
Count of Participants [Participants]	0 0%	1 2.2%

5. Secondary Outcome

Title	Number of Participants With Closed Drainage System Disrupted During Placement of Catheter
Description	Participants were monitored post surgery until time of discharge. This is the number of participants who had the closed drainage system disrupted during placement of catheter for back fill of the bladder during surgery.
Time Frame	Day 1 post op

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard of Care Protocol Catheter Insertion	Aseptic Protocol for Catheter Insertion
Arm/Group Description	Standard of care catheter insertion in which catheter is inserted right out of package/non-treated catheter. Standard of care catheter insertion: Catheter inserted right out of package.	Aseptic protocol for catheter insertion using Povidone Iodine treated catheter and maintaining plastic sleeve on catheter Catheter insertion with Povidone Iodine: The catheter will be treated with Povidone Iodine prior to insertion.
Measure Participants	45	45
Count of Participants [Participants]	42 93.3%	42 93.3%

6. Secondary Outcome

Title	Number of Participants That Were Readmitted, Had Additional Clinic Visits or Went to the Emergency Department (ED) for Any Reason
Description	Participants were monitored up to two weeks. This is the number of participants who had at least one readmission or emergency room visit during the time of observation.
Time Frame	Day 14 (+/- 2 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard of Care Protocol Catheter Insertion	Aseptic Protocol for Catheter Insertion
Arm/Group Description	Standard of care catheter insertion in which catheter is inserted right out of package/non-treated catheter. Standard of care catheter insertion: Catheter inserted right out of package.	Aseptic protocol for catheter insertion using Povidone Iodine treated catheter and maintaining plastic sleeve on catheter Catheter insertion with Povidone Iodine: The catheter will be treated with Povidone Iodine prior to insertion.
Measure Participants	45	45
Count of Participants [Participants]	0 0%	1 2.2%

7. Secondary Outcome

Title	Number of Patients That Used Antibiotics at the Time of Surgery and Post-surgery
Description	Participants were monitored for up to 2 weeks. This is the number of participants that used any antibiotic during surgery and post-surgery.
Time Frame	Day 14 (+/- 2 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard of Care Protocol Catheter Insertion	Aseptic Protocol for Catheter Insertion
Arm/Group Description	Standard of care catheter insertion in which catheter is inserted right out of package/non-treated catheter. Standard of care catheter insertion: Catheter inserted right out of package.	Aseptic protocol for catheter insertion using Povidone Iodine treated catheter and maintaining plastic sleeve on catheter Catheter insertion with Povidone Iodine: The catheter will be treated with Povidone Iodine prior to insertion.
Measure Participants	45	45
Cefazolin (1st gen cephalosporin))	36 80%	39 86.7%
Cefoxitin Cefuroxime / Cefotetan (2nd gen cephalo	5 11.1%	0 0%
Metronidazole	12 26.7%	11 24.4%
Clindamycin	5 11.1%	6 13.3%
Doxycycline	0 0%	0 0%
Gentamicin	3 6.7%	6 13.3%

Adverse Events

Time Frame	14 days +/- 2 days post-surgery
Arm/Group Title	Standard of Care Protocol Catheter Insertion		Aseptic Protocol for Catheter Insertion
Arm/Group Description	Standard of care catheter insertion in which catheter is inserted right out of package/non-treated catheter. Standard of care catheter insertion: Catheter inserted right out of package.		Aseptic protocol for catheter insertion using Povidone Iodine treated catheter and maintaining plastic sleeve on catheter Catheter insertion with Povidone Iodine: The catheter will be treated with Povidone Iodine prior to insertion.
All Cause Mortality
	Standard of Care Protocol Catheter Insertion		Aseptic Protocol for Catheter Insertion
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/45 (0%)		0/45 (0%)
Serious Adverse Events
	Standard of Care Protocol Catheter Insertion		Aseptic Protocol for Catheter Insertion
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/45 (0%)		0/45 (0%)
Other (Not Including Serious) Adverse Events
	Standard of Care Protocol Catheter Insertion		Aseptic Protocol for Catheter Insertion
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/45 (4.4%)		3/45 (6.7%)
Blood and lymphatic system disorders
Neutropenic fever	0/45 (0%)	0	1/45 (2.2%)	1
Gastrointestinal disorders
Constipation	0/45 (0%)	0	1/45 (2.2%)	1
Renal and urinary disorders
Hematuria	1/45 (2.2%)	1	0/45 (0%)	0
Surgical and medical procedures
Catheter discomfort	1/45 (2.2%)	1	1/45 (2.2%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.