PROJECT PREVENT: Metronidazole Antibiotic Per Vagina Before Hysterectomy: Is Additional Antibiotic Prophylaxis Beneficial?

NCT04478617 | Unknown Phase 4 FDA Drug

• 1 other identifier: 14176
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 2

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.

Conditions

Post-Op Infection

Keywords

Hysterectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Individual rates of patient reported symptoms and documented post-operative infections by the 4 to 8-week post-operative visit.

  8 weeks following surgery.

Study Arms (2)

Metronidazole

EXPERIMENTAL

Drug: Metronidazole Vaginal

Control

NO INTERVENTION

Interventions

Metronidazole Vaginal DRUG

Vaginal metronidazole 0.75% (MetroGel or Vandazole) will be inserted per vagina days 1 through 5 prior to date of surgery.

Also known as: MetroGel, Vandazole

Metronidazole

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• New York Medical College: lead

Study Sites (2)

NYC Health + Hospitals/Metropolitan Hospital

New York, New York, 10029, United States

Location

Westchester Medical Center/New York Medical College

Valhalla, New York, 10595, United States

Location

Related Publications (1)

• 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.

  PMID: 38596254 DERIVED

MeSH Terms

Interventions

Metronidazole; Benchmarking

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Management Audit; Organization and Administration; Health Services Administration; Program Evaluation; Quality of Health Care; Quality Assurance, Health Care; Health Care Quality, Access, and Evaluation; Health Care Evaluation Mechanisms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2020
• First Posted: July 20, 2020
• Study Start: July 15, 2020
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: May 17, 2023

Record last verified: 2023-05

Locations

US (2)