Clinical trial NCT04478617: PROJECT PREVENT: Metronidazole Antibiotic Per Vagina Before Hysterectomy: Is Additional Antibiotic Prophylaxis Beneficial?
Official title: PROJECT PREVENT: Metronidazole Antibiotic Per Vagina Before Hysterectomy: Is Additional Antibiotic Prophylaxis Beneficial?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Post-Op Infection
Keywords: Hysterectomy
Lead sponsor: New York Medical College
Sponsor class: OTHER
First posted: 2020-07-20
Enrollment: 136
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Despite use of intravenous antibiotic prophylaxis, pelvic infection including vaginal and urinary complaints and infections are still noted after hysterectomy. For gynecologic surgery the burden of infection is not only from the skin but from the vagina and urinary tract. Hysterectomy involves a communication via the cervical or vaginal canal directly with the pelvis and thus can lead to a potentially increased risk of infection from both aerobic and anaerobic organisms. Vaginal metronidazole is a standard of care antibiotic for vaginal infections including bacterial vaginosis. Based upon small studies in the peri-operative setting, vaginal metronidazole may provide a benefit in decreasing surgical site infections and urinary infections in conjunction with standard infection prevention protocols.

This study is for women undergoing elective subtotal or total hysterectomy by any route of surgery. The main objective of this study is to evaluate if metronidazole inserted per vagina daily for 5 days before elective hysterectomy decreases patient complaints of potential infection or documented post-operative infection.

Subjects will be randomized to an intervention or control group. For subjects in the intervention group, vaginal metronidazole 0.75% (MetroGel or Vandazole) will be prescribed and inserted per vagina days 1 through 5 prior to date of surgery. The control group will not receive a metronidazole prescription.

Detailed description: Standard of care surgical site infection (SSI) antibiotic prophylaxis for elective hysterectomy is a single intravenous antibiotic. Despite use of intravenous antibiotic prophylaxis, pelvic infection including vaginal and urinary complaints and infections are still often noted after hysterectomy. For gynecologic surgery the burden of infection is not only from the skin but from the vagina and urinary tract. Hysterectomy involves a communication via the cervical or vaginal canal directly with the pelvis and thus can lead to a potentially increased risk of infection from both aerobic and anaerobic organisms.

There has been scant retrospective data examining the use of metronidazole as an adjunct to standard antibiotic prophylaxis for hysterectomy. A few previous studies have examined the use of vaginal metronidazole in patients who had a documented overgrowth of normal bacterial flora (e.g. diagnosed with bacterial vaginosis) prior to hysterectomy in pre-menopausal women only and found a significant difference in prevention of infections.

Vaginal metronidazole is a standard of care antibiotic for vaginal infections including bacterial vaginosis. Based upon small studies in the peri-operative setting, vaginal metronidazole may provide a benefit in decreasing surgical site infections and urinary infections in conjunction with standard infection prevention protocols.

For post-operative patients, the symptoms of vaginal discharge, dysuria, pelvic pain and wound erythema/induration/drainage is not only distressing for the patient but leads to additional phone calls, patient visits, laboratory and radiology evaluation and possibly additional pain, and antibiotic prescriptions. This increased use of health care services can cause a burden to our health care system and diminish overall patient satisfaction. Therefore, if additional prophylaxis can also prevent patient reported symptoms of post-operative infection, the intervention may be of value.

The objective of this study is to investigate if metronidazole inserted per vagina daily for 5 days before elective hysterectomy decreases patient complaints of potential infection or documented post-operative infection.

Subjects randomized to the intervention are required to pick up the antibiotic at their own pharmacy. They must then insert the antibiotic per vagina once daily on days 1-5 (day 5 being the day before their scheduled operation).

There are no study related visits, imaging, or testing required above standard peri-operative procedures as per their gynecologic surgeon. Subjects randomized to the control group (no antibiotic) are followed for data collection only. Subjects in both groups will have a routine hospital stay for surgery and their routine follow up for post-operative care as per the standard practice of the gynecologic surgeon.

Eligibility criteria: Inclusion Criteria:

* Any female aged 18 years old and over
* Patient scheduled for elective subtotal (removal of uterus only with or without ovaries) or total hysterectomy (removal of uterus and cervix with or without ovaries) by any route of surgery. Procedures will include laparoscopic, robotic, open and vaginal approaches.

Exclusion Criteria:

* Known hypersensitivity to metronidazole (oral or vaginal)
* Hysterectomy scheduled within 5 days of study enrollment (ie there will not be enough time to complete the study drug course)
* Suspected active bacterial vaginosis at time of consent

Primary outcomes:
measure: Composite variable of patient reported symptom or documented post-operative infection by the 4 to 8-week post-operative visit(s).
timeFrame: 8 weeks following surgery.
Secondary outcomes:
measure: Individual rates of patient reported symptoms and documented post-operative infections by the 4 to 8-week post-operative visit.
timeFrame: 8 weeks following surgery.
Other outcomes:
Locations:
city: New York
country: United States
facility: NYC Health + Hospitals/Metropolitan Hospital
state: New York
city: Valhalla
country: United States
facility: Westchester Medical Center/New York Medical College
state: New York
Study officials:
References: