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Comparison between ampicillin-sulbactam and cefoxitin as prophylaxis antibiotics in patients undergoing pancreaticoduodenectomy after preoperative biliary drainage

Comparison between ampicillin-sulbactam and cefoxitin as prophylaxis antibiotics in patients undergoing pancreaticoduodenectomy after preoperative biliary drainage : A Randomized controlled Trial

Status
Unknown
Phases
Phase 1
Study type
Interventional
Source
TCTR
Registry ID
TCTR20220120001
Enrollment
140
Registered
2022-01-20
Start date
2020-07-19
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Surgical site infection in patients undergone pancreaticoduodenectomy with preoperative biliary drainage . Surgical site infection , SSI , biliary drainage

Interventions

Standard preoperative antibiotic and postoperative antibiotic Perioperative phase
2g intravenous every 2 hour Post operative for 24 hour
1g intravenous every 6 hour,Standard Preoperative antibiotic and postoperative antibiotic Perioperative phase
3g intravenous every 2 hour Post operative for 24 hour
3g intravenous every 6 hour
Active Comparator Drug,Active Comparator Drug
Cefoxitin,Ampicillin-sulbactam

Sponsors

Ramathibodi hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age more than 18 2.Patients underwent Pancreaticoduodenectomy

Exclusion criteria

Exclusion criteria: 1.patients that not underwent preoperative biliary drainage. 2.Patients with history of drug allergy

Design outcomes

Primary

MeasureTime frame
Surgical site infection At 12 months after end of intervention Wound infection rate

Secondary

MeasureTime frame
Length of hospital stay Within first admission or Re-admitted within 30 days Length of hospital stay (days)

Countries

Thailand

Contacts

Public ContactRuj Rujchasenee

Faculty of Medicine Ramathibodi Hospital

Peem.ruj@gmail.com6622011315

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026