Catheter Infection, Catheter-Related Infections, Urinary Tract Infections
Conditions
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.
Interventions
DRUGCatheter insertion with Povidone Iodine
The catheter will be treated with Povidone Iodine prior to insertion.
PROCEDUREStandard of care catheter insertion
Catheter inserted right out of package.
Sponsors
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Patients with normal urinary analysis (UA) pre-surgery will be randomized 1:1 to one of two arms prior to surgery: 1. Aseptic protocol for catheter insertion using Povidone Iodine treated catheter and maintaining plastic sleeve on catheter or 2. Standard of care (SOC) catheter insertion in which catheter is inserted right out of package/non-treated catheter.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 89 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 45 |
| 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. | 45 |
| Total | 90 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did not meet eligibility criteria | 2 | 1 |
| Overall Study | Lost to Follow-up | 1 | 4 |
| Overall Study | Physician Decision | 0 | 1 |
Baseline characteristics
| Characteristic | Aseptic Protocol for Catheter Insertion | Total | Standard of Care Protocol Catheter Insertion |
|---|---|---|---|
| Age, Continuous | 56.5 years STANDARD_DEVIATION 14.27 | 56.2 years STANDARD_DEVIATION 13.75 | 56.0 years STANDARD_DEVIATION 13.37 |
| Cancer Diagnosis Benign | 8 Participants | 13 Participants | 5 Participants |
| Cancer Diagnosis Cervical | 2 Participants | 4 Participants | 2 Participants |
| Cancer Diagnosis Other | 1 Participants | 3 Participants | 2 Participants |
| Cancer Diagnosis Ovarian Cancer | 24 Participants | 50 Participants | 26 Participants |
| Cancer Diagnosis Uterine Cancer | 10 Participants | 20 Participants | 10 Participants |
| Diabetes | 6 Participants | 10 Participants | 4 Participants |
| Hypertension | 18 Participants | 34 Participants | 16 Participants |
| Menopause status Post-menopausal | 30 Participants | 60 Participants | 30 Participants |
| Menopause status Pre-menopausal | 15 Participants | 30 Participants | 15 Participants |
| Primary Surgery Bilateral/unilateral salpingo-oophorectomy | 5 Participants | 8 Participants | 3 Participants |
| Primary Surgery Bowel resection | 2 Participants | 6 Participants | 4 Participants |
| Primary Surgery Lymph Node Dissection | 0 Participants | 1 Participants | 1 Participants |
| Primary Surgery Omentectomy | 4 Participants | 10 Participants | 6 Participants |
| Primary Surgery Other | 6 Participants | 12 Participants | 6 Participants |
| Primary Surgery Radical Hysterectomy | 0 Participants | 2 Participants | 2 Participants |
| Primary Surgery Total Abdominal Hysterectomy +/- BSO/USO | 28 Participants | 51 Participants | 23 Participants |
| Race/Ethnicity, Customized Race/ethnic group African American | 1 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized Race/ethnic group American Indian or Alaskan Native | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Race/ethnic group Asian | 2 Participants | 3 Participants | 1 Participants |
| Race/Ethnicity, Customized Race/ethnic group Hispanic | 6 Participants | 8 Participants | 2 Participants |
| Race/Ethnicity, Customized Race/ethnic group White Non-Hispanic | 36 Participants | 76 Participants | 40 Participants |
| Sex: Female, Male Female | 45 Participants | 90 Participants | 45 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Smoking status Current | 6 Participants | 11 Participants | 5 Participants |
| Smoking status Former | 17 Participants | 29 Participants | 12 Participants |
| Smoking status Never | 22 Participants | 50 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 45 | 0 / 45 |
| other Total, other adverse events | 2 / 45 | 3 / 45 |
| serious Total, serious adverse events | 0 / 45 | 0 / 45 |
Outcome results
Primary
Number of Participants With a Catheter Associated Urinary Tract Infection (CAUTI)
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care Protocol Catheter Insertion | Number of Participants With a Catheter Associated Urinary Tract Infection (CAUTI) | 7 Participants |
| Aseptic Protocol for Catheter Insertion | Number of Participants With a Catheter Associated Urinary Tract Infection (CAUTI) | 6 Participants |
Secondary
Average Patient Satisfaction
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care Protocol Catheter Insertion | Average Patient Satisfaction | 8.17 score on a scale | Standard Deviation 2.39 |
| Aseptic Protocol for Catheter Insertion | Average Patient Satisfaction | 8.6 score on a scale | Standard Deviation 2.04 |
Secondary
Number of Participants That Were Readmitted, Had Additional Clinic Visits or Went to the Emergency Department (ED) for Any Reason
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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care Protocol Catheter Insertion | Number of Participants That Were Readmitted, Had Additional Clinic Visits or Went to the Emergency Department (ED) for Any Reason | 0 Participants |
| Aseptic Protocol for Catheter Insertion | Number of Participants That Were Readmitted, Had Additional Clinic Visits or Went to the Emergency Department (ED) for Any Reason | 1 Participants |
Secondary
Number of Participants Who Received the Fill and Pull Versus the Pull and Void Method of Catheter Discontinuation
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)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard of Care Protocol Catheter Insertion | Number of Participants Who Received the Fill and Pull Versus the Pull and Void Method of Catheter Discontinuation | Fill and pull | 38 Participants |
| Standard of Care Protocol Catheter Insertion | Number of Participants Who Received the Fill and Pull Versus the Pull and Void Method of Catheter Discontinuation | Pull and void | 7 Participants |
| Aseptic Protocol for Catheter Insertion | Number of Participants Who Received the Fill and Pull Versus the Pull and Void Method of Catheter Discontinuation | Fill and pull | 40 Participants |
| Aseptic Protocol for Catheter Insertion | Number of Participants Who Received the Fill and Pull Versus the Pull and Void Method of Catheter Discontinuation | Pull and void | 5 Participants |
Secondary
Number of Participants With Closed Drainage System Disrupted During Placement of Catheter
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care Protocol Catheter Insertion | Number of Participants With Closed Drainage System Disrupted During Placement of Catheter | 42 Participants |
| Aseptic Protocol for Catheter Insertion | Number of Participants With Closed Drainage System Disrupted During Placement of Catheter | 42 Participants |
Secondary
Number of Participants With Extended Hospital Stay Due to a Urinary Tract Infection (UTI)
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care Protocol Catheter Insertion | Number of Participants With Extended Hospital Stay Due to a Urinary Tract Infection (UTI) | 0 Participants |
| Aseptic Protocol for Catheter Insertion | Number of Participants With Extended Hospital Stay Due to a Urinary Tract Infection (UTI) | 1 Participants |
Secondary
Number of Patients That Used Antibiotics at the Time of Surgery and Post-surgery
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)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard of Care Protocol Catheter Insertion | Number of Patients That Used Antibiotics at the Time of Surgery and Post-surgery | Cefazolin (1st gen cephalosporin)) | 36 Participants |
| Standard of Care Protocol Catheter Insertion | Number of Patients That Used Antibiotics at the Time of Surgery and Post-surgery | Cefoxitin Cefuroxime / Cefotetan (2nd gen cephalo | 5 Participants |
| Standard of Care Protocol Catheter Insertion | Number of Patients That Used Antibiotics at the Time of Surgery and Post-surgery | Metronidazole | 12 Participants |
| Standard of Care Protocol Catheter Insertion | Number of Patients That Used Antibiotics at the Time of Surgery and Post-surgery | Clindamycin | 5 Participants |
| Standard of Care Protocol Catheter Insertion | Number of Patients That Used Antibiotics at the Time of Surgery and Post-surgery | Doxycycline | 0 Participants |
| Standard of Care Protocol Catheter Insertion | Number of Patients That Used Antibiotics at the Time of Surgery and Post-surgery | Gentamicin | 3 Participants |
| Aseptic Protocol for Catheter Insertion | Number of Patients That Used Antibiotics at the Time of Surgery and Post-surgery | Doxycycline | 0 Participants |
| Aseptic Protocol for Catheter Insertion | Number of Patients That Used Antibiotics at the Time of Surgery and Post-surgery | Cefazolin (1st gen cephalosporin)) | 39 Participants |
| Aseptic Protocol for Catheter Insertion | Number of Patients That Used Antibiotics at the Time of Surgery and Post-surgery | Clindamycin | 6 Participants |
| Aseptic Protocol for Catheter Insertion | Number of Patients That Used Antibiotics at the Time of Surgery and Post-surgery | Cefoxitin Cefuroxime / Cefotetan (2nd gen cephalo | 0 Participants |
| Aseptic Protocol for Catheter Insertion | Number of Patients That Used Antibiotics at the Time of Surgery and Post-surgery | Gentamicin | 6 Participants |
| Aseptic Protocol for Catheter Insertion | Number of Patients That Used Antibiotics at the Time of Surgery and Post-surgery | Metronidazole | 11 Participants |