Trial Outcomes & Findings for Tolerance of Chlorhexidine Gluconate Vaginal Cleansing Solution (NCT NCT03305159)
NCT ID: NCT03305159
Last Updated: 2019-06-27
Results Overview
To determine and compare the number of participants with vaginal or urinary symptoms after treatment with chlorhexidine gluconate versus povidone iodine vaginal cleansing solutions.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
134 participants
Primary outcome timeframe
Day of surgery to 24-48 hours after surgery
Results posted on
2019-06-27
Participant Flow
Participant milestones
| Measure |
Control (Povidone Iodine)
Patients to receive povidone iodine for the surgical preparation of the vagina.
Povidone-Iodine: Patients will receive povidone iodine for the surgical preparation of the vagina.
|
Intervention (4% Chlorhexidine Gluconate)
Patients to receive 4% chlorhexidine gluconate for the surgical preparation of the vagina.
4% Chlorhexidine Gluconate: Patients will receive 4% chlorhexidine gluconate for the surgical preparation of the vagina.
|
|---|---|---|
|
Overall Study
STARTED
|
66
|
68
|
|
Overall Study
COMPLETED
|
63
|
60
|
|
Overall Study
NOT COMPLETED
|
3
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Tolerance of Chlorhexidine Gluconate Vaginal Cleansing Solution
Baseline characteristics by cohort
| Measure |
Control (Povidone Iodine)
n=63 Participants
Patients to receive povidone iodine for the surgical preparation of the vagina.
Povidone-Iodine: Patients will receive povidone iodine for the surgical preparation of the vagina.
|
Intervention (4% Chlorhexidine Gluconate)
n=60 Participants
Patients to receive 4% chlorhexidine gluconate for the surgical preparation of the vagina.
4% Chlorhexidine Gluconate: Patients will receive 4% chlorhexidine gluconate for the surgical preparation of the vagina.
|
Total
n=123 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
59 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Continuous
|
46 years
STANDARD_DEVIATION 10 • n=5 Participants
|
44 years
STANDARD_DEVIATION 9 • n=7 Participants
|
45 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
63 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
123 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
41 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
63 participants
n=5 Participants
|
60 participants
n=7 Participants
|
123 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day of surgery to 24-48 hours after surgeryPopulation: Number of participants in control and active groups
To determine and compare the number of participants with vaginal or urinary symptoms after treatment with chlorhexidine gluconate versus povidone iodine vaginal cleansing solutions.
Outcome measures
| Measure |
Control (Povidone Iodine)
n=63 Participants
Patients to receive povidone iodine for the surgical preparation of the vagina.
Povidone-Iodine: Patients will receive povidone iodine for the surgical preparation of the vagina.
|
Intervention (4% Chlorhexidine Gluconate)
n=59 Participants
Patients to receive 4% chlorhexidine gluconate for the surgical preparation of the vagina.
4% Chlorhexidine Gluconate: Patients will receive 4% chlorhexidine gluconate for the surgical preparation of the vagina.
|
|---|---|---|
|
Number of Participants With Vaginal or Urinary Symptoms After Surgery, Assessed by Validated Questionnaire (Modified PRO-CTCAE)
Vaginal itchiness
|
7 Participants
|
7 Participants
|
|
Number of Participants With Vaginal or Urinary Symptoms After Surgery, Assessed by Validated Questionnaire (Modified PRO-CTCAE)
Vaginal dryness
|
4 Participants
|
11 Participants
|
|
Number of Participants With Vaginal or Urinary Symptoms After Surgery, Assessed by Validated Questionnaire (Modified PRO-CTCAE)
Vaginal burning
|
8 Participants
|
25 Participants
|
|
Number of Participants With Vaginal or Urinary Symptoms After Surgery, Assessed by Validated Questionnaire (Modified PRO-CTCAE)
Unusual vaginal discharge
|
10 Participants
|
14 Participants
|
|
Number of Participants With Vaginal or Urinary Symptoms After Surgery, Assessed by Validated Questionnaire (Modified PRO-CTCAE)
Pain of burning with urination
|
9 Participants
|
17 Participants
|
Adverse Events
Control (Povidone Iodine)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention (4% Chlorhexidine Gluconate)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Control (Povidone Iodine)
n=63 participants at risk
Patients to receive povidone iodine for the surgical preparation of the vagina.
Povidone-Iodine: Patients will receive povidone iodine for the surgical preparation of the vagina.
|
Intervention (4% Chlorhexidine Gluconate)
n=59 participants at risk；n=60 participants at risk
Patients to receive 4% chlorhexidine gluconate for the surgical preparation of the vagina.
4% Chlorhexidine Gluconate: Patients will receive 4% chlorhexidine gluconate for the surgical preparation of the vagina.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Severe Swelling
|
0.00%
0/63 • Data were collected for each patient immediately postoperatively to 24-48 hours postoperatively.
The survey of vaginal \& urinary symptoms used in this study was designed using the PRO-CTCAE (Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events) created by the NIH \& NCI 7. The language \& format of the PTO-CTCAE questions have been cognitively tested. Questions on vaginal burning and itching were investigator-developed items using similar language as the PRO-CTCAE, since these adverse events were not contained in the PRO-CTCAE item library.
|
1.7%
1/59 • Number of events 1 • Data were collected for each patient immediately postoperatively to 24-48 hours postoperatively.
The survey of vaginal \& urinary symptoms used in this study was designed using the PRO-CTCAE (Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events) created by the NIH \& NCI 7. The language \& format of the PTO-CTCAE questions have been cognitively tested. Questions on vaginal burning and itching were investigator-developed items using similar language as the PRO-CTCAE, since these adverse events were not contained in the PRO-CTCAE item library.
|
Additional Information
Supriya Rastogi
Northwestern University Feinberg School of Medicine
Phone: [email protected]
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place