NCT03990974

Postoperative Antimicrobial Prophylaxis Versus Placebo for Infection Prevention in HCC After Liver Resection

Postoperative Antimicrobial Prophylaxis Versus Placebo for Infection Prevention in Hepatocellular Carcinoma After Liver Resection: A Multi-center, Randomized, Open-labelled Trial.

• Status: Suspended
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 458 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This trial is a multi-center, double-blinded, randomized (1:1) clinical trial. The aim is to compare the postoperative infection rate between the 3 days postoperative AMP group and the placebo group in HCC patients undergoing hepatectomy.

Detailed description

This trial includes two phase. The first phase is the internal pilot study to explore the expulsion rate and recruited population. The second phase is the main phase III trial.

Conditions

• Hepatocellular Carcinoma
• Postoperative Infection

Interventions

Type	Name	Description
DRUG	postoperative antimicrobial prophylaxis	The drugs are all common antibiotics used to prevent postoperative infection in each hospital.
OTHER	No postoperative antimicrobial prophylaxis	Patients will receive no antibiotics after hepatectomy unless necessary.

Timeline

• Start date: 2020-09-01
• Primary completion: 2021-06-01
• Completion: 2021-07-01
• First posted: 2019-06-19
• Last updated: 2020-03-25

Locations

1 site across 1 country: China