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Comparison of one day with four days antibiotic use in cancer patients

Standard prophylactic antibiotics for one day versus extended usage for 4 days in clean contaminated oncological surgeries- A randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/06/014344
Enrollment
280
Registered
2018-06-01
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- The patients will be those who will be undergoing clean, contaminated, planned cancer surgeries of abdomen

Interventions

Intervention1: Single dose prophylactic antibiotic versus antibiotic for 4 days to prevent surgical site infection: We are comparing incidence of surgical site infection in patients who receive one do

Sponsors

Basavatarakam IndoAmerican Cancer Hospital and Research Institute
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Clean contaminated oncological surgeries i.e., gastrointestinal, gynaecological and urological surgeries 2.Age group 15 to 75 years

Exclusion criteria

Exclusion criteria: 1.Patients less than 15 years old (pediatric age). 2.Those with known allergy to cephalosporin antibiotics. 3.Those with any infection within the prior 2 weeks. 4.Those patient whose White Blood Cell (WBC) count is less than 3000 cells per cubic millimeter of blood /WBC counts more than 12000/mm3 . 5.Any patient who develops infection after the surgery will be recorded as an event and removed from the study and will be treated as per as standard antibiotic protocol. 6.Cases in which intraoperatively a major breach of sterility with gross contamination and uncontrolled spillage from gastrointestinal track has occurred. 7.Contaminated and infected surgeries as per CDC definition. 8.Clean surgeries as per CDC definition.

Design outcomes

Primary

MeasureTime frame
The primary outcome is to show that the one dose-prophylaxis was not inferior to the multiple-dose prophylaxis in terms of the overall incidence of surgical site infections.Timepoint: 30 days

Secondary

MeasureTime frame
To determine the factors influencing the risk of surgical site infectionTimepoint: 30 days

Countries

India

Contacts

Public ContactAbhijit Nair

Department of Anaesthesiology

abhijitnair95@gmail.com9963180495

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 26, 2026