Hysterectomy
Conditions
Brief summary
This is a randomized controlled trial to determine the influence of chlorhexidine gluconate surgical/topical antiseptic solutions on the bacterial environment of the vagina during hysterectomy and compare that to the effect of standard iodine-based preparations on the same.
Detailed description
Postoperative infection remains the most common complication of surgical procedures in gynecology. Historically, 30-40% of patients undergoing a hysterectomy develop a post-operative infection. The initiation of antibiotic prophylaxis for appropriate surgical procedures was a significant advancement in the prevention of surgical site infection. Antibiotic prophylaxis has been standardized and universally implemented. A remaining variable is the method of aseptic preparation of the vagina with substantial variation of technique being reported even within institutions. The most recent Committee Opinion by the American College of Obstetricians and Gynecologists concludes there is insufficient evidence to render a strong recommendation for either povidone-iodine or chlorhexidine as the ideal agent for surgical preparation of the vagina and that further evidence is necessary. Povidone-iodine solution has been considered the standard for aseptic surgical preparation of the vagina for decades and is the only solution approved by the FDA for vaginal use. There are however specific qualities of the solution that suggest it may be less than ideal for use in the vagina. More contemporary efforts have begun to focus on chlorhexidine as a more ideal agent for aseptic efforts in surgical preparation of the vagina. The purpose of our study is to use a randomized controlled trial to determine if chlorhexidine gluconate surgical preparation maintains a lower rate of contamination to the surgical field.
Interventions
DRUGChlorhexidine
Chlorhexidine preparation solutions
DRUGIodine
Iodine-based preparation solutions
Sponsors
TriHealth Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Undergoing total vaginal, laparoscopic assisted vaginal, total laparoscopic, or robotic-assisted laparoscopic hysterectomy by a physician at Cincinnati Urogynecology Associates or Tri-State Gynecology Oncology TriHealth Inc. * Concomitant procedures such as vaginal vault suspension, suburethral sling, cystoscopy, enterocele repair, anterior or posterior colporrhaphy, bilateral salpingectomy or salpingooophorectomy, staging procedures, lymph node sampling and other indicated procedures will be included * English speaking * Ability to provide consent
Exclusion criteria
* Unwillingness to participate in the study * Non English speaking * Patients that do not undergo a hysterectomy * Reported allergy to iodine or chlorhexidine preparation solutions * Patients undergoing planned debulking surgery for ovarian, fallopian tube or primary peritoneal cancers * Current infection necessitating hysterectomy * Active sepsis, pelvic abscess or pelvic inflammatory disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Contamination | 90 minutes from initial preparation | Contamination is defined as having \>5000 bacteria within a culture |
Countries
United States
Participant flow
Pre-assignment details
6 patients were excluded (3 - not randomized at the day of surgery; 3 - missing study consent).
Participants by arm
| Arm | Count |
|---|---|
| Chlorhexidine Group Chlorhexidine: Chlorhexidine preparation solutions | 44 |
| Iodine Group Iodine: Iodine-based preparation solutions | 41 |
| Total | 85 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Exclusion criteria - patient receiving Flagyl for treatment | 1 | 0 |
| Overall Study | Incorrect labeling of samples | 2 | 0 |
Baseline characteristics
| Characteristic | Chlorhexidine Group | Iodine Group | Total |
|---|---|---|---|
| Age, Continuous | 57.6 years STANDARD_DEVIATION 10.9 | 62.2 years STANDARD_DEVIATION 11.6 | 59.8 years STANDARD_DEVIATION 11.4 |
| Bacterial Vaginosis (BV) positive | 12 Participants | 18 Participants | 30 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Black/African American | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized White | 42 Participants | 39 Participants | 81 Participants |
| Region of Enrollment United States | 44 Participants | 41 Participants | 85 Participants |
| Sex: Female, Male Female | 44 Participants | 41 Participants | 85 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 / 44 | 0 / 41 |
| other Total, other adverse events | 0 / 44 | 0 / 41 |
| serious Total, serious adverse events | 0 / 44 | 0 / 41 |
Outcome results
Primary
Number of Participants With Contamination
Contamination is defined as having \>5000 bacteria within a culture
Time frame: 90 minutes from initial preparation
Population: Use participants with cultures at 90 minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Chlorhexidine Group | Number of Participants With Contamination | 20 Participants |
| Iodine Group | Number of Participants With Contamination | 35 Participants |
Comparison: We hypothesized that chlorhexidine would have a lower bacterial count compared to iodine. Our sample size was calculated to be 71 patients per arm to detect a 22% difference in cultures defined as contaminated at 90 minutes from surgical preparation.p-value: <0.00195% CI: [3.02, 37.34]Regression, Logistic