Post-Op InfectionPhase 4PREVENTNCT04478617
PROJECT PREVENT: Metronidazole Antibiotic Per Vagina Before Hysterectomy: Is Additional Antibiotic Prophylaxis Beneficial?
A Phase 4 study testing Metronidazole Vaginal in people with Post-Op Infection, run by New York Medical College at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Post-Op Infection
- What is being tested?
- Metronidazole Vaginal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Jul 2020to May 2023
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
NYC Health + Hospitals/Metropolitan Hospital
New York, New York, 10029
Westchester Medical Center/New York Medical College
Valhalla, New York, 10595
About this study
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.
Read the 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.
- Conditions
- Post-Op Infection
- Being tested
- Metronidazole Vaginal
- Keywords
- Hysterectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metronidazole VaginalDrug
Also called MetroGel, Vandazole
Vaginal metronidazole 0.75% (MetroGel or Vandazole) will be inserted per vagina days 1 through 5 prior to date of surgery.
| Study group | Role | What they receive |
|---|---|---|
| Metronidazole | Experimental | Not described Receives: Drug: Metronidazole Vaginal |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks following surgery.
Secondary outcomes (1)
Individual rates of patient reported symptoms and documented post-operative infections by the 4 to 8-week post-operative visit.
Measured: 8 weeks following surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start15 Jul 2020
- Primary completionMay 2023 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-Op InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04478617
- Sponsor's protocol ID
- 14176
- Acronym
- PREVENT
- Status last verified
- May 2023
- First submitted
- 16 Jul 2020
- Last updated
- 17 May 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Pradhan T, Zhang H, Kadesh A, Buskwofie A, Patankar S, Menon S, Ryntz T, Grimes CL. PROJECT PREVENT: a randomized controlled trial of preoperative vaginal metronidazole to decrease patient issues and infections after hysterectomy. BMJ Surg Interv Health Technol. 2024 Apr 4;6(1):e000241. doi: 10.1136/bmjsit-2023-000241. eCollection 2024.
PubMed 38596254
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROJECT PREVENT: Metronidazole Antibiotic Per Vagina Before Hysterectomy: Is Additional Antibiotic Prophylaxis Beneficial?
- ClinicalTrials.gov ID
- NCT04478617
- Acronym / sponsor ID
- PREVENT / 14176
- Conditions
- Post-Op Infection
- Keywords
- Hysterectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- New York Medical CollegeUniversity, hospital or other
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 20 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metronidazole | Experimental | Drug: Metronidazole Vaginal |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metronidazole VaginalAlso: MetroGel, VandazoleVaginal metronidazole 0.75% (MetroGel or Vandazole) will be inserted per vagina days 1 through 5 prior to date of surgery. | Drug | Metronidazole |
Primary outcome
Composite variable of patient reported symptom or documented post-operative infection by the 4 to 8-week post-operative visit(s).
Time frame: 8 weeks following surgery.
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.
1 secondary outcome
Individual rates of patient reported symptoms and documented post-operative infections by the 4 to 8-week post-operative visit.
Time frame: 8 weeks following surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
- Derived from this study: PubMed 38596254Pradhan T, Zhang H, Kadesh A, Buskwofie A, Patankar S, Menon S, Ryntz T, Grimes CL. PROJECT PREVENT: a randomized controlled trial of preoperative vaginal metronidazole to decrease patient issues and infections after hysterectomy. BMJ Surg Interv Health Technol. 2024 Apr 4;6(1):e000241. doi: 10.1136/bmjsit-2023-000241. eCollection 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metronidazole Vaginal in people with Post-Op Infection, run by New York Medical College at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite variable of patient reported symptom or documented post-operative infection by the 4 to 8-week post-operative visit(s). (time frame: 8 weeks following surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04478617, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2023.