Surgical Preparation of the Vagina
Conditions
Brief summary
Conduct a randomized control study to compare the tolerance of 4% chlorhexidine gluconate/4% isopropyl alcohol versus povidone iodine vaginal cleansing solutions for surgical preparations of the vagina. Patients will be randomized to either control (povidone iodine) or experimental (chlorhexidine gluconate), and then be given a short survey prior to and immediately after surgery, and again 24-48 hours via phone asking them about the presence and severity of vaginal dryness, burning, itchiness, unusual vaginal discharge, and pain or burning with urination.
Detailed description
Surgical site antisepsis is critical in preventing surgical site infections. Although chlorhexidine gluconate has proven to be superior to povidone iodine for surgical site antisepsis, povidone iodine is the only FDA-approved antiseptic solution for surgical preparation of the vagina. Many surgeons are hesitant to use chlorhexidine gluconate for preoperative vaginal cleansing due to the alcohol dissolvent present in the solutions that is implicated in a greater risk of irritation. Yet, there has been no randomized study to illustrate whether the risk of vaginal irritation is greater in chlorhexidine gluconate versus povidone iodine. Thus, the purpose of the study is to conduct a randomized control trial to compare the tolerance of 4% chlorhexidine gluconate to povidone iodine using patient-reported outcomes of vaginal or urinary symptoms. Patients will be randomized to either control or experimental, and then be given a short survey prior to and immediately after surgery, and again 24-48 hours via phone asking them about the presence and severity of vaginal dryness, burning, itchiness, unusual vaginal discharge, and pain or burning with urination.
Interventions
DRUGPovidone-Iodine
Patients will receive povidone iodine for the surgical preparation of the vagina.
Patients will receive 4% chlorhexidine gluconate for the surgical preparation of the vagina.
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Masking description
Patients will be randomized to the control or intervention and not be told which antiseptic they received for the surgical preparation of the vagina.
Intervention model description
Eligible patients will be randomized to either the control (povidone iodine) or intervention (chlorhexidine gluconate).
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Undergoing hysteroscopy 2. Gynecologic dilation & curettage 3. Endometrial ablation 4. Essure without concomitant laparoscopy
Exclusion criteria
1. Pregnant 2. Have a history of atopic dermatitis, vaginal irritation, allergic reactions, or anaphylaxis to chlorhexidine gluconate or povidone iodine.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Vaginal or Urinary Symptoms After Surgery, Assessed by Validated Questionnaire (Modified PRO-CTCAE) | Day of surgery to 24-48 hours after surgery | To determine and compare the number of participants with vaginal or urinary symptoms after treatment with chlorhexidine gluconate versus povidone iodine vaginal cleansing solutions. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 63 |
| 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. | 60 |
| Total | 123 |
Baseline characteristics
| Characteristic | Intervention (4% Chlorhexidine Gluconate) | Total | Control (Povidone Iodine) |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 5 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 59 Participants | 118 Participants | 59 Participants |
| Age, Continuous | 44 years STANDARD_DEVIATION 9 | 45 years STANDARD_DEVIATION 9.7 | 46 years STANDARD_DEVIATION 10 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 6 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 17 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 10 Participants | 20 Participants | 10 Participants |
| Race (NIH/OMB) White | 39 Participants | 80 Participants | 41 Participants |
| Region of Enrollment United States | 60 participants | 123 participants | 63 participants |
| Sex: Female, Male Female | 60 Participants | 123 Participants | 63 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 63 | 0 / 60 |
| other Total, other adverse events | 0 / 63 | 1 / 59 |
| serious Total, serious adverse events | 0 / 63 | 0 / 60 |
Outcome results
Primary
Number of Participants With Vaginal or Urinary Symptoms After Surgery, Assessed by Validated Questionnaire (Modified PRO-CTCAE)
To determine and compare the number of participants with vaginal or urinary symptoms after treatment with chlorhexidine gluconate versus povidone iodine vaginal cleansing solutions.
Time frame: Day of surgery to 24-48 hours after surgery
Population: Number of participants in control and active groups
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control (Povidone Iodine) | Number of Participants With Vaginal or Urinary Symptoms After Surgery, Assessed by Validated Questionnaire (Modified PRO-CTCAE) | Vaginal dryness | 4 Participants |
| Control (Povidone Iodine) | Number of Participants With Vaginal or Urinary Symptoms After Surgery, Assessed by Validated Questionnaire (Modified PRO-CTCAE) | Pain of burning with urination | 9 Participants |
| Control (Povidone Iodine) | Number of Participants With Vaginal or Urinary Symptoms After Surgery, Assessed by Validated Questionnaire (Modified PRO-CTCAE) | Vaginal burning | 8 Participants |
| Control (Povidone Iodine) | Number of Participants With Vaginal or Urinary Symptoms After Surgery, Assessed by Validated Questionnaire (Modified PRO-CTCAE) | Vaginal itchiness | 7 Participants |
| Control (Povidone Iodine) | Number of Participants With Vaginal or Urinary Symptoms After Surgery, Assessed by Validated Questionnaire (Modified PRO-CTCAE) | Unusual vaginal discharge | 10 Participants |
| Intervention (4% Chlorhexidine Gluconate) | Number of Participants With Vaginal or Urinary Symptoms After Surgery, Assessed by Validated Questionnaire (Modified PRO-CTCAE) | Vaginal itchiness | 7 Participants |
| Intervention (4% Chlorhexidine Gluconate) | Number of Participants With Vaginal or Urinary Symptoms After Surgery, Assessed by Validated Questionnaire (Modified PRO-CTCAE) | Vaginal dryness | 11 Participants |
| Intervention (4% Chlorhexidine Gluconate) | Number of Participants With Vaginal or Urinary Symptoms After Surgery, Assessed by Validated Questionnaire (Modified PRO-CTCAE) | Unusual vaginal discharge | 14 Participants |
| Intervention (4% Chlorhexidine Gluconate) | Number of Participants With Vaginal or Urinary Symptoms After Surgery, Assessed by Validated Questionnaire (Modified PRO-CTCAE) | Pain of burning with urination | 17 Participants |
| Intervention (4% Chlorhexidine Gluconate) | Number of Participants With Vaginal or Urinary Symptoms After Surgery, Assessed by Validated Questionnaire (Modified PRO-CTCAE) | Vaginal burning | 25 Participants |