Status:

COMPLETED

Pharmacokinetic Study of Vancomycin, Clindamycin And/or Gentamicin Administration During Surgery Using a Microdialysis Procedure

Lead Sponsor:

Poitiers University Hospital

Conditions:

Surgical Site Infection

Eligibility:

All Genders

18-80 years

Phase:

PHASE1

Brief Summary

The surgical site infection is one of the most important causes of postoperative morbidity. The appropriate antibiotic prophylaxis is one of the most effective way to prevent surgical site infections....

Eligibility Criteria

Inclusion

  • Adult patient between 18 and 80 years old
  • Patient with history of beta-lactam hypersensitivity
  • Patient who underwent abdominal or orthopedic surgery whose forseeable time exceeds 1 hour and requires a surgical antibiotic prophylaxis by vancomycin or clindamycin + gentamicin

Exclusion

  • morbid obesity (BMI \> 35 kg/m2)
  • mild to severe renal impairment (clearance creatinine \< 60 ml/min)
  • vancomycin, clindamycin or gentamicin hypersensitivity
  • pregnancy

Key Trial Info

Start Date :

May 26 2019

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 4 2024

Estimated Enrollment :

25 Patients enrolled

Trial Details

Trial ID

NCT03845790

Start Date

May 26 2019

End Date

September 4 2024

Last Update

January 16 2025

Active Locations (1)

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1

CHU de Poitiers

Poitiers, France