Not Yet RecruitingPhase 4ACTRN12624000370505

Randomized Controlled Trial of Duration of Antibiotic Prophylaxis in Head and Neck Surgery with Free Flap Reconstruction, HEDAX Trial

Randomized Controlled Trial of Duration of Antibiotic Prophylaxis in Head and Neck Surgery with Free Flap Reconstruction for Adult Patients with Head and Neck Cancer, HEDAX Trial


Sponsor

The Royal Melbourne Hospital, Melbourne Health

Enrollment

526 participants

Start Date

Apr 1, 2024

Study Type

Interventional

Conditions

Summary

Study Purpose: The purpose of this research is to establish whether 72 hours of antibiotics is superior to 24 hours of antibiotics in preventing infections of surgical wounds. Who is it for? You may be eligible for this study if you are an adult male or female Undergoing head and neck tumour resection and primary free flap reconstructive surgery for upper aerodigestive tract defects. Study details Participants will be randomly assigned to either 72-hour or 24-hour peri-operation antibiotic prophylaxis groups. Post head and neck operation and free flap reconstructive surgery, they will be monitored from postoperative day 1 to day 30 for incidence of surgical site infection using methods like culture, biochemical tests, radiological imaging, clinical diagnosis and Clavien-Dindo Classification of Surgical complications. It is hoped this information will improve perioperative management so that the best possible outcomes from surgery are achieved for patients having these major procedures.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria3

  • Aged greater than or equal to 18 years of age
  • Undergoing tumour resection and primary free flap reconstructive surgery for upper aerodigestive tract defects
  • Clean-contaminated procedure (Centers for Disease Control and Prevention [CDC] criteria)

Exclusion Criteria1

  • Patients who are unable to consent for themselves (e.g., due to cognitive or intellectual impairment)

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Interventions

72-h group: Participants receiving 72 hours peri-operative antibiotic prophylaxis (9 doses of 2g intravenous cefazolin every 8 hours, 6 doses of 500mg intravenous metronidazole every 12 hours) Adminis

72-h group: Participants receiving 72 hours peri-operative antibiotic prophylaxis (9 doses of 2g intravenous cefazolin every 8 hours, 6 doses of 500mg intravenous metronidazole every 12 hours) Administered by the anaesthetists and registered nurses.


Locations(1)

NSW,QLD,VIC, Australia

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