Gynecologic Disease, Pelvic Floor Disorders, Pelvic Organ Prolapse, Post-Op Infection, Surgical Site Infection, Urinary Incontinence, Urinary Tract Infections
Conditions
Keywords
Urogynecology, Surgery, Antiseptic Preparation
Brief summary
This is a randomized controlled trial to determine if there is a difference between chlorhexidine gluconate and povidone iodine vaginal preparations for urogynecological surgery post operative infections.
Detailed description
The purpose of this randomized controlled trial is to determine whether there is a difference in efficacy of two of the most common commercially available vaginal surgical preparations. The first objective is to determine whether chlorhexidine gluconate is non-inferior to povidone iodine with respect to post-operative infections including urinary tract infections (both culture proven and empirically treated) and surgical site infections (as defined by the Centers for Disease Control). The second objective is to determine whether chlorhexidine gluconate is non-inferior to povidone iodine with respect to vulvar and vaginal irritation.
Interventions
DRUGVaginal scrub, to be applied vaginally and perineally immediately prior to surgery.
Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.
Sponsors
University of New Mexico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants will be anesthetized during the intervention and will not be informed of the arm of their randomization
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Female Subjects \>18 years of age * English or Spanish speaking/reading * Must be able to provide informed consent * Undergoing urogynecologic procedures or surgery
Exclusion criteria
* Pregnant - all patients are verified regarding pregnancy status prior to gynecologic surgical intervention at all sites of surgery - for patients who are premenopausal and have a uterus, a urine pregnancy test is administered in the preoperative setting. Pregnancy status is also determined prior to this in the office setting by interview and patient provided history prior to offering surgery to the patient. * Inability to return for follow-up visits * No concurrent need for vaginal antisepsis, such as cases of sacral neuromodulation * Lack of telephone * Known allergy to either antiseptic agent * Prisoners will not be eligible to participate in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Urinary Tract Infection | 2 weeks post operatively | Urinary tract infection as defined by positive urine culture of \>10,000 cfu, or empirically treated symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Surgical Site Infection | 14 days postoperatively | Surgical site infection as defined by CDC guidelines: https://www.cdc.gov/nhsn/pdfs/pscmanual/9pscssicurrent.pdf |
| Vaginal Irritation | Post operative day 1 | Vaginal 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)) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 61 |
| 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. | 58 |
| Total | 119 |
Baseline characteristics
| Characteristic | Total | Chlorhexidine Gluconate | Povidone Iodine |
|---|---|---|---|
| Age, Continuous | 57.5 years STANDARD_DEVIATION 12.5 | 58 years STANDARD_DEVIATION 13 | 57 years STANDARD_DEVIATION 12 |
| Race/Ethnicity, Customized African American | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized American Indian | 17 Participants | 5 Participants | 12 Participants |
| Race/Ethnicity, Customized Latinx | 51 Participants | 26 Participants | 25 Participants |
| Race/Ethnicity, Customized Other | 6 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized White | 50 Participants | 30 Participants | 20 Participants |
| Region of Enrollment United States | 119 participants | 61 participants | 58 participants |
| Sex: Female, Male Female | 119 Participants | 61 Participants | 58 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 / 61 | 0 / 58 |
| other Total, other adverse events | 0 / 61 | 0 / 58 |
| serious Total, serious adverse events | 4 / 61 | 4 / 58 |
Outcome results
Primary
Rate of Urinary Tract Infection
Urinary tract infection as defined by positive urine culture of \>10,000 cfu, or empirically treated symptoms.
Time frame: 2 weeks post operatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Chlorhexidine Gluconate | Rate of Urinary Tract Infection | 4 Participants |
| Povidone Iodine | Rate of Urinary Tract Infection | 7 Participants |
Secondary
Rate of Surgical Site Infection
Surgical site infection as defined by CDC guidelines: https://www.cdc.gov/nhsn/pdfs/pscmanual/9pscssicurrent.pdf
Time frame: 14 days postoperatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Chlorhexidine Gluconate | Rate of Surgical Site Infection | 1 Participants |
| Povidone Iodine | Rate of Surgical Site Infection | 2 Participants |
Secondary
Vaginal Irritation
Vaginal 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))
Time frame: Post operative day 1
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Chlorhexidine Gluconate | Vaginal Irritation | Vaginal irritation - 0 | 50 Participants |
| Chlorhexidine Gluconate | Vaginal Irritation | Vaginal irritation - 1 | 1 Participants |
| Chlorhexidine Gluconate | Vaginal Irritation | Vaginal irritation - 2 | 1 Participants |
| Chlorhexidine Gluconate | Vaginal Irritation | Vaginal irritation - 3 | 0 Participants |
| Chlorhexidine Gluconate | Vaginal Irritation | Vaginal irritation - 4 or 5 | 2 Participants |
| Povidone Iodine | Vaginal Irritation | Vaginal irritation - 4 or 5 | 2 Participants |
| Povidone Iodine | Vaginal Irritation | Vaginal irritation - 3 | 2 Participants |
| Povidone Iodine | Vaginal Irritation | Vaginal irritation - 1 | 0 Participants |
| Povidone Iodine | Vaginal Irritation | Vaginal irritation - 0 | 50 Participants |
| Povidone Iodine | Vaginal Irritation | Vaginal irritation - 2 | 0 Participants |