Post-Op Infection Clinical Trial
— PREVENTOfficial title:
PROJECT PREVENT: Metronidazole Antibiotic Per Vagina Before Hysterectomy: Is Additional Antibiotic Prophylaxis Beneficial?
Verified date | May 2023 |
Source | New York Medical College |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 136 |
Est. completion date | May 2023 |
Est. primary completion date | May 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | NYC Health + Hospitals/Metropolitan Hospital | New York | New York |
United States | Westchester Medical Center/New York Medical College | Valhalla | New York |
Lead Sponsor | Collaborator |
---|---|
New York Medical College |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Composite variable of patient reported symptom or documented post-operative infection by the 4 to 8-week post-operative visit(s). | Patient reported symptom= patient report of dysuria, vaginal discharge with or without pelvic pain, fever, wound redness/erythema/drainage documented in the post-operative visit or complaint that generates an additional post-operative visit for evaluation.
Documented post-operative infection= Urinary tract infection either empirically treated with antibiotics or culture proven infection, vaginal discharge with or without pelvic pain or that warrants treatment with antibiotics, vaginal cuff cellulitis or vaginitis, pelvic abscess (confirmed by pelvic ultrasound or CT scan with or without vaginal cultures) that results in antibiotic use. |
8 weeks following surgery. | |
Secondary | Individual rates of patient reported symptoms and documented post-operative infections by the 4 to 8-week post-operative visit. | 8 weeks following surgery. |
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