Trial Outcomes & Findings for Reducing Urinary Tract Infection Rates Using a Controlled Aseptic Protocol for Catheter Insertion (NCT NCT03101371)
NCT ID: NCT03101371
Last Updated: 2020-03-10
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
99 participants
Primary outcome timeframe
Within 14 +/- 2 days post-surgery
Results posted on
2020-03-10
Participant Flow
A single-site randomized controlled trial, conducted at the University of Colorado Hospital, enrolled women beginning October 2017 and ended February 2019.
Participant milestones
| Measure |
Standard of Care Protocol Catheter Insertion
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
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.
|
|---|---|---|
|
Overall Study
STARTED
|
48
|
51
|
|
Overall Study
COMPLETED
|
45
|
45
|
|
Overall Study
NOT COMPLETED
|
3
|
6
|
Reasons for withdrawal
| Measure |
Standard of Care Protocol Catheter Insertion
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
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.
|
|---|---|---|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
4
|
|
Overall Study
Did not meet eligibility criteria
|
2
|
1
|
Baseline Characteristics
Reducing Urinary Tract Infection Rates Using a Controlled Aseptic Protocol for Catheter Insertion
Baseline characteristics by cohort
| Measure |
Standard of Care Protocol Catheter Insertion
n=45 Participants
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
n=45 Participants
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
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.0 years
STANDARD_DEVIATION 13.37 • n=99 Participants
|
56.5 years
STANDARD_DEVIATION 14.27 • n=107 Participants
|
56.2 years
STANDARD_DEVIATION 13.75 • n=206 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=99 Participants
|
45 Participants
n=107 Participants
|
90 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/ethnic group · White Non-Hispanic
|
40 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
76 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/ethnic group · Hispanic
|
2 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/ethnic group · American Indian or Alaskan Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/ethnic group · African American
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/ethnic group · Asian
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Menopause status
Pre-menopausal
|
15 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Menopause status
Post-menopausal
|
30 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
|
Smoking status
Current
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Smoking status
Former
|
12 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Smoking status
Never
|
28 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
|
Diabetes
|
4 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Hypertension
|
16 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Cancer Diagnosis
Uterine Cancer
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Cancer Diagnosis
Ovarian Cancer
|
26 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
|
Cancer Diagnosis
Cervical
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Cancer Diagnosis
Benign
|
5 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Cancer Diagnosis
Other
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Primary Surgery
Total Abdominal Hysterectomy +/- BSO/USO
|
23 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
|
Primary Surgery
Radical Hysterectomy
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Primary Surgery
Bowel resection
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Primary Surgery
Omentectomy
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Primary Surgery
Bilateral/unilateral salpingo-oophorectomy
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Primary Surgery
Lymph Node Dissection
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Primary Surgery
Other
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Within 14 +/- 2 days post-surgeryParticipants 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.
Outcome measures
| Measure |
Standard of Care Protocol Catheter Insertion
n=45 Participants
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
n=45 Participants
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.
|
|---|---|---|
|
Number of Participants With a Catheter Associated Urinary Tract Infection (CAUTI)
|
7 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Standard of Care Protocol Catheter Insertion
n=45 Participants
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
n=45 Participants
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.
|
|---|---|---|
|
Number of Participants Who Received the "Fill and Pull" Versus the "Pull and Void" Method of Catheter Discontinuation
Fill and pull
|
38 Participants
|
40 Participants
|
|
Number of Participants Who Received the "Fill and Pull" Versus the "Pull and Void" Method of Catheter Discontinuation
Pull and void
|
7 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Standard of Care Protocol Catheter Insertion
n=45 Participants
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
n=45 Participants
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.
|
|---|---|---|
|
Average Patient Satisfaction
|
8.17 score on a scale
Standard Deviation 2.39
|
8.6 score on a scale
Standard Deviation 2.04
|
SECONDARY outcome
Timeframe: 14 days (+/- 2 days) from surgeryParticipants 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.
Outcome measures
| Measure |
Standard of Care Protocol Catheter Insertion
n=45 Participants
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
n=45 Participants
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.
|
|---|---|---|
|
Number of Participants With Extended Hospital Stay Due to a Urinary Tract Infection (UTI)
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 1 post opParticipants 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.
Outcome measures
| Measure |
Standard of Care Protocol Catheter Insertion
n=45 Participants
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
n=45 Participants
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.
|
|---|---|---|
|
Number of Participants With Closed Drainage System Disrupted During Placement of Catheter
|
42 Participants
|
42 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Standard of Care Protocol Catheter Insertion
n=45 Participants
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
n=45 Participants
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.
|
|---|---|---|
|
Number of Participants That Were Readmitted, Had Additional Clinic Visits or Went to the Emergency Department (ED) for Any Reason
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Standard of Care Protocol Catheter Insertion
n=45 Participants
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
n=45 Participants
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.
|
|---|---|---|
|
Number of Patients That Used Antibiotics at the Time of Surgery and Post-surgery
Cefazolin (1st gen cephalosporin))
|
36 Participants
|
39 Participants
|
|
Number of Patients That Used Antibiotics at the Time of Surgery and Post-surgery
Cefoxitin Cefuroxime / Cefotetan (2nd gen cephalo
|
5 Participants
|
0 Participants
|
|
Number of Patients That Used Antibiotics at the Time of Surgery and Post-surgery
Metronidazole
|
12 Participants
|
11 Participants
|
|
Number of Patients That Used Antibiotics at the Time of Surgery and Post-surgery
Clindamycin
|
5 Participants
|
6 Participants
|
|
Number of Patients That Used Antibiotics at the Time of Surgery and Post-surgery
Gentamicin
|
3 Participants
|
6 Participants
|
|
Number of Patients That Used Antibiotics at the Time of Surgery and Post-surgery
Doxycycline
|
0 Participants
|
0 Participants
|
Adverse Events
Standard of Care Protocol Catheter Insertion
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Aseptic Protocol for Catheter Insertion
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Standard of Care Protocol Catheter Insertion
n=45 participants at risk
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
n=45 participants at risk
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.
|
|---|---|---|
|
Surgical and medical procedures
Catheter discomfort
|
2.2%
1/45 • Number of events 1 • 14 days +/- 2 days post-surgery
|
2.2%
1/45 • Number of events 1 • 14 days +/- 2 days post-surgery
|
|
Blood and lymphatic system disorders
Neutropenic fever
|
0.00%
0/45 • 14 days +/- 2 days post-surgery
|
2.2%
1/45 • Number of events 1 • 14 days +/- 2 days post-surgery
|
|
Renal and urinary disorders
Hematuria
|
2.2%
1/45 • Number of events 1 • 14 days +/- 2 days post-surgery
|
0.00%
0/45 • 14 days +/- 2 days post-surgery
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/45 • 14 days +/- 2 days post-surgery
|
2.2%
1/45 • Number of events 1 • 14 days +/- 2 days post-surgery
|
Additional Information
Saketh Guntupalli, MD
University of Colorado, Anshcutz Medical Campus
Phone: 303-724-2033
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place