Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000370505
Ethics application status
Approved
Date submitted
29/02/2024
Date registered
28/03/2024
Date last updated
28/03/2024
Date data sharing statement initially provided
28/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomized Controlled Trial of Duration of Antibiotic Prophylaxis in Head and Neck Surgery with Free Flap Reconstruction, HEDAX Trial
Scientific title
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
Secondary ID [1] 311629 0
None
Universal Trial Number (UTN)
Trial acronym
HEDAX trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Head & Neck Cancer 333070 0
Post-operative Infection 333232 0
Condition category
Condition code
Cancer 329756 329756 0 0
Head and neck
Surgery 329919 329919 0 0
Surgical techniques
Infection 329920 329920 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 328089 0
Prevention
Comparator / control treatment
24-h group: Participants receiving 24 hours peri-operative antibiotic prophylaxis (3 doses of 2g intravenous cefazolin every 8 hours, 2 doses of 500mg intravenous metronidazole every 12 hours). Administered by the anaesthetists and registered nurses.
Control group
Active

Outcomes
Primary outcome [1] 337540 0
Incidence of surgical site infections (SSI) in patients having head and neck tumour resection and free flap reconstruction.
Timepoint [1] 337540 0
Day 1 to Day 30 Post-operatively
Secondary outcome [1] 432254 0
Other surgical outcomes including other infections (Urinary tract infection [UTI], pneumonia, C. difficile infection, sepsis), composite secondary outcome
Timepoint [1] 432254 0
Day 1 to Day 30 Post-operatively
Secondary outcome [2] 433021 0
Flap Loss, Return to theatre, mortality, composite secondary outcome
Timepoint [2] 433021 0
Day 1 to Day 30 Post-operatively
Secondary outcome [3] 433022 0
Hospital Length of Stay
Timepoint [3] 433022 0
Day1 to Day 30 Post-operatively

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who are unable to consent for themselves (e.g., due to cognitive or intellectual impairment)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2024
Actual
Date of last participant enrolment
Anticipated
1/04/2026
Actual
Date of last data collection
Anticipated
1/05/2026
Actual
Sample size
Target
526
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC

Funding & Sponsors
Funding source category [1] 315899 0
Charities/Societies/Foundations
Name [1] 315899 0
Australian Society of Plastic Surgeons (ASPS) Research Grant 2023
Country [1] 315899 0
Australia
Primary sponsor type
Hospital
Name
The Royal Melbourne Hospital, Melbourne Health
Address
Country
Australia
Secondary sponsor category [1] 318090 0
None
Name [1] 318090 0
Address [1] 318090 0
Country [1] 318090 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314746 0
The Royal Melbourne Hospital Human Research Ethics Committee
Ethics committee address [1] 314746 0
https://www.thermh.org.au/research/researchers/ethics
Ethics committee country [1] 314746 0
Australia
Date submitted for ethics approval [1] 314746 0
20/04/2023
Approval date [1] 314746 0
22/08/2023
Ethics approval number [1] 314746 0
HREC/94335/MH-2023

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132590 0
Mr Anand Ramakrishnan
Address 132590 0
The Royal Melbourne Hospital, Level 6 East, 300 Grattan Street Parkville VIC 3050
Country 132590 0
Australia
Phone 132590 0
+61 3 9342 7410
Fax 132590 0
Email 132590 0
Anand.Ramakrishnan@mh.org.au
Contact person for public queries
Name 132591 0
Anand Ramakrishnan
Address 132591 0
The Royal Melbourne Hospital, Level 6 East, 300 Grattan Street Parkville VIC 3050
Country 132591 0
Australia
Phone 132591 0
+61 3 9342 7410
Fax 132591 0
Email 132591 0
Anand.Ramakrishnan@mh.org.au
Contact person for scientific queries
Name 132592 0
Anand Ramakrishnan
Address 132592 0
The Royal Melbourne Hospital, Level 6 East, 300 Grattan Street Parkville VIC 3050
Country 132592 0
Australia
Phone 132592 0
+61 3 9342 7410
Fax 132592 0
Email 132592 0
Anand.Ramakrishnan@mh.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.