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The effect of prophylaxis with systemic metronidazole and cefazolin on surgical site infection in hysterectomy and ovarian resection.

Investigating the effect of prophylaxis with systemic metronidazole and cefazolin in surgical site infection on uterus and ovaries removal surgery: a randomized clinical trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20120623010089N5
Enrollment
332
Registered
2025-06-27
Start date
2025-07-01
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acquired absence of genital organ(s). Acquired absence of genital organ(s)

Interventions

Intervention 1: Intervention group: Patients will receive a single dose of 500 mg metronidazole ampoule the night before surgery, and on the day of surgery, they will also receive 2 grams of intraveno

Sponsors

Rasht University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: ge over 18 years Women who are candidates for abdominal hysterectomy and ovarian cystectomy Consent to participate in the study

Exclusion criteria

Exclusion criteria: Sensitivity to metronidazole Emergency hysterectomy Hysterectomy after cesarean section or vaginal delivery or in the postpartum period Receiving broad-spectrum antibiotics before surgery Vaginitis or cervicitis Unwillingness to participate in the study

Design outcomes

Primary

MeasureTime frame
Documented postoperative infection or patient-reported symptoms, including fever, unusual pain, purulent discharge from the incision site or vagina, indicating infection. Timepoint: Postoperative visits, including the third day visit and the 2-6 week post-operative visit. Method of measurement: By clinical examination by a gynecologist or symptoms reported by the patient, including (fever, abnormal pain, purulent discharge from the incision site or vagina) indicating infection.

Secondary

MeasureTime frame
Intraoperative complications: Blood transfusion, intestinal injury, urinary tract injury, estimated mean blood loss. Timepoint: During the operation. Method of measurement: Recording information during the operation.;Postoperative complications: Fever, purulent discharge from the vagina or incision site, and abnormal abdominal and pelvic pain, burning sensation during urination, wound redness, erythema, drainage, vaginal discharge, vaginal cuff cellulitis or vaginitis, pelvic floor abscess. Timepoint: Visit on the third day after surgery. Method of measurement: Visit and view patient records.;Length of hospital stay. Timepoint: Patients will be followed up for up to 6 weeks. Method of measurement: Visit and view patient records.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Roya Faraji Darkhaneh

Rasht University of Medical Sciences

Royafarajidarkhaneh1371@gmail.com+98 13 3336 9224

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026