Trial Outcomes & Findings for Chlorhexidine vs. Iodine for Vaginal Preparation in Urogynecologic Procedures (NCT NCT04048356)
NCT ID: NCT04048356
Last Updated: 2023-07-10
Results Overview
Urinary tract infection as defined by positive urine culture of \>10,000 cfu, or empirically treated symptoms.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
137 participants
Primary outcome timeframe
2 weeks post operatively
Results posted on
2023-07-10
Participant Flow
Participant milestones
| Measure |
Chlorhexidine Gluconate
Chlorhexidine gluconate 2% vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.
Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.: Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.
|
Povidone Iodine
Povidone iodine vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.
Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.: Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.
|
|---|---|---|
|
Overall Study
STARTED
|
72
|
65
|
|
Overall Study
COMPLETED
|
61
|
58
|
|
Overall Study
NOT COMPLETED
|
11
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Chlorhexidine vs. Iodine for Vaginal Preparation in Urogynecologic Procedures
Baseline characteristics by cohort
| Measure |
Chlorhexidine Gluconate
n=61 Participants
Chlorhexidine gluconate 2% vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.
Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.: Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.
|
Povidone Iodine
n=58 Participants
Povidone iodine vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.
Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.: Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.
|
Total
n=119 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58 years
STANDARD_DEVIATION 13 • n=99 Participants
|
57 years
STANDARD_DEVIATION 12 • n=107 Participants
|
57.5 years
STANDARD_DEVIATION 12.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
61 Participants
n=99 Participants
|
58 Participants
n=107 Participants
|
119 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
African American
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
30 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Latinx
|
26 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
American Indian
|
5 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
61 participants
n=99 Participants
|
58 participants
n=107 Participants
|
119 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 2 weeks post operativelyUrinary tract infection as defined by positive urine culture of \>10,000 cfu, or empirically treated symptoms.
Outcome measures
| Measure |
Chlorhexidine Gluconate
n=61 Participants
Chlorhexidine gluconate 2% vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.
Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.: Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.
|
Povidone Iodine
n=58 Participants
Povidone iodine vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.
Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.: Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.
|
|---|---|---|
|
Rate of Urinary Tract Infection
|
4 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 14 days postoperativelySurgical site infection as defined by CDC guidelines: https://www.cdc.gov/nhsn/pdfs/pscmanual/9pscssicurrent.pdf
Outcome measures
| Measure |
Chlorhexidine Gluconate
n=61 Participants
Chlorhexidine gluconate 2% vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.
Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.: Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.
|
Povidone Iodine
n=58 Participants
Povidone iodine vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.
Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.: Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.
|
|---|---|---|
|
Rate of Surgical Site Infection
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Post operative day 1Vaginal irritation (including specific symptoms of discomfort, burning, or itching) based on a 5-point scale (Likert type, from 0 minimum/better to 5 maximum/worse, total score reported))
Outcome measures
| Measure |
Chlorhexidine Gluconate
n=54 Participants
Chlorhexidine gluconate 2% vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.
Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.: Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.
|
Povidone Iodine
n=54 Participants
Povidone iodine vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.
Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.: Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.
|
|---|---|---|
|
Vaginal Irritation
Vaginal irritation - 0
|
50 Participants
|
50 Participants
|
|
Vaginal Irritation
Vaginal irritation - 1
|
1 Participants
|
0 Participants
|
|
Vaginal Irritation
Vaginal irritation - 2
|
1 Participants
|
0 Participants
|
|
Vaginal Irritation
Vaginal irritation - 3
|
0 Participants
|
2 Participants
|
|
Vaginal Irritation
Vaginal irritation - 4 or 5
|
2 Participants
|
2 Participants
|
Adverse Events
Chlorhexidine Gluconate
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Povidone Iodine
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Chlorhexidine Gluconate
n=61 participants at risk
Chlorhexidine gluconate 2% vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.
Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.: Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.
|
Povidone Iodine
n=58 participants at risk
Povidone iodine vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.
Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.: Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.
|
|---|---|---|
|
Infections and infestations
Surgical Site Infection
|
1.6%
1/61 • Number of events 1 • 6 weeks
|
3.4%
2/58 • Number of events 2 • 6 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.00%
0/61 • 6 weeks
|
1.7%
1/58 • Number of events 1 • 6 weeks
|
|
Skin and subcutaneous tissue disorders
Suture reaction
|
0.00%
0/61 • 6 weeks
|
1.7%
1/58 • Number of events 1 • 6 weeks
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
1.6%
1/61 • Number of events 1 • 6 weeks
|
0.00%
0/58 • 6 weeks
|
|
Infections and infestations
Bacterial Vaginosis
|
1.6%
1/61 • Number of events 1 • 6 weeks
|
0.00%
0/58 • 6 weeks
|
|
Renal and urinary disorders
Urethral injury
|
1.6%
1/61 • Number of events 1 • 6 weeks
|
0.00%
0/58 • 6 weeks
|
Other adverse events
Adverse event data not reported
Additional Information
Peter Jeppson, site contact for study
University of New Mexico
Phone: 505-967-8428
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place