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)
- Conditions
- Health Condition 1: null- A benign gynaecological pathology for which the patient would be undergoing a surgical procedureHealth Condition 2: O- Medical and Surgical
- Registration Number
- CTRI/2020/06/025621
- Lead Sponsor
- Post Graduate Institute of Medical Education and Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
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
1 Emergency Procedures
2 Associated co-morbidities like diabetes, anemia (Hb < 10g%) and jaundice
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Difference in duration of hospital stay post surgery between two groups <br/ ><br>Timepoint: For 1 month post surgery