drugset / Trial / NCT06454643

Gentamicin in Cardiac Surgery

NCT06454643 ↗

Completed 50 enrolled Al-Rasheed University College
RandomizedParallel-groupDouble-blindPrevention

Summary

Surgical site infection (SSI) is a serious postoperative complication after cardiac surgery that have a negative impact on a patient's health and survival. This study aims to investigate the effectiveness of administering gentamicin in reducing the incidence of SSI with monitoring to the effective therapeutic level.

Timeline

Start
2020-01-01
Primary completion
2021-01-01
Completion
2021-01-01

Outcome

Mixed primary results

paper Primary end-points: new/worsening renal impairment, surgical site infection (SSI), Clostridium difficile infection (CDI). PMID 23837413 ↗

paper New or worsening renal impairment was less frequent with gentamicin (4.3% group 1 vs. 3.4% group 2, p=NS). PMID 23837413 ↗

paper There were fewer wound infections in group 2: SSI 3.2% (group 1) versus 2.7% (group2) (p=NS); PMID 23837413 ↗

paper There were nine CDIs in group 1 compared with one in group 2 (p=0.02). PMID 23837413 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ceftriaxone Other / unclassified 1 g —
Subject Gentamicin Small molecule 80 mg —
Background FLOXACILLIN Small molecule 1 g —

Indications

No indication recorded.