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A Randomized Controlled Trial To Compare Antibiotic Prophylaxis In Elective Gynaecological Surgeries - Single Dose Cefazolin (choice of antibiotic in surgical prophylaxis) Versus Single Dose Of Cefazolin And Tinidazole (Tinidazole is an antibiotic given to cover for anaerobes)

A Randomized Controlled Trial To Compare Antibiotic Prophylaxis In Elective Gynaecological Surgeries - Single Dose Cefazolin Versus Single Dose Of Cefazolin And Tinidazole.

Status
Active, not recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/06/025621
Enrollment
200
Registered
2020-06-04
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- A benign gynaecological pathology for which the patient would be undergoing a surgical procedure Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: Cefazolin: Cefazolin is the drug of choice for surgical prophylaxis.The recommended dose of Cefazolin is 2g and should be given by intravenous route 30-60 minutes prior to surgical inci

Sponsors

Post Graduate Institute of Medical Education and Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients undergoing elective gynecological surgeries such as â?? 1 Abdominal/Laparoscopic/Vaginal Hysterectomy 2 Surgeries for pelvic organ prolapse/stress urinary incontinence 3 Exploratory Laparotomies

Exclusion criteria

Exclusion criteria: 1 Emergency Procedures 2 Associated co-morbidities like diabetes, anemia (Hb 3 Patients with immuno-compromised conditions like retrovirus positive, renal disease, on immuno suppressive therapy or chemotherapy 4 Patients with autoimmune disorders. 5 Patients with localized skin infection 6 With suspected or proven malignancies 7 Suspected infective procedure 8 Known allergy to Cefazolin / Tinidazole 9 Not willing to participate 10 History of any antibiotic within 7 days before surgery 11 History of fever within 7 days before surgery 12 Unexpected Intra-operative complications

Design outcomes

Primary

MeasureTime frame
To study the difference in rates of surgical site infection, febrile morbidity and urinary tract infections in the two groups of surgical prophylactic antibioticsTimepoint: For 1 month post surgery

Secondary

MeasureTime frame
Difference in duration of hospital stay post surgery between two groups Timepoint: For 1 month post surgery

Countries

India

Contacts

Public ContactDr Shivani Garg

Post Graduate Institute of Medical Education and Research

drseemachopra@yahoo.com

Outcome results

None listed

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