None listed
Conditions
Brief 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.
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) Administered by the anaesthetists and registered nurses.
72-h group: Participants receiving 72 hours peri-operative antibiotic prophylaxis
Cefazolin Intravenous [2g, (3g if weight >120kg)] Intra-operative: First dose on induction, re-dosing at 4 hourly intervals, Post-operative: 7-8 doses at 8 hourly intervals from last intra-operative dose# and Metronidazole Intravenous (500mg) Intra-operative: First dose on induction, Post -operative: 5 Subsequent doses at 12 hourly intervals
# Dependent on duration of surgery. Do not administer at or beyond 72ho
72-h group: Participants receiving 72 hours peri-operative antibiotic prophylaxis Cefazolin Intravenous [2g, (3g if weight >120kg)] Intra-operative: First dose on induction, re-dosing at 4 hourly intervals, Post-operative: 7-8 doses at 8 hourly intervals from last intra-operative dose# and Metronidazole Intravenous (500mg) Intra-operative: First dose on induction, Post -operative: 5 Subsequent doses at 12 hourly intervals # Dependent on duration of surgery. Do not administer at or beyond 72hour from start of surgery. (Patients with hypersensitivity to penicillin - Clindamycin Intravenous (600mg) Intra-operative: First dose on induction, re-dosing at 6 hourly intervals, Post-operative: 7 doses at 8 hourly intervals from last intra-op dose) Administered by the anaesthetists and registered nurses.
Sponsors
The Royal Melbourne Hospital, Melbourne Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• 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 criteria
Patients who are unable to consent for themselves (e.g., due to cognitive or intellectual impairment)
Outcome results
None listed