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Spray application of skin antisepsis in head and neck surgery

The effect of spray application of skin antisepsis on post-operative surgical site infection rate in patients undergoing head and neck surgery.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622000059763
Enrollment
432
Registered
2022-01-18
Start date
2022-05-05
Completion date
2022-12-01
Last updated
2023-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

When performing head and neck surgery, the skin at the site of the surgical incision is prepared with antiseptic solution to help prevent wound infections. There is good evidence that the iodine-containing solution povidone iodine (PVI) is effective at reducing the rate of post-operative wound infection. The solution can be applied either by painting or spraying the surgical site, although there is very little evidence to suggest which method is superior at preventing wound infections. This research project aims to test whether the spray-on method is as good as or better than the paint-on method at preventing wound infections.

Interventions

Randomised controlled trial comparing two different methods of application of the same agent for skin antisepsis prior to head and neck surgery. Participants will be randomly assigned to one of two groups. Aqueous 10% povidone iodine (PVI) solution will be used in each group, and the area of skin surrounding the planned surgical incision will be prepared. This is a routine standard of care in these patients, and the only difference between groups will be the method of application of the soluti

Randomised controlled trial comparing two different methods of application of the same agent for skin antisepsis prior to head and neck surgery. Participants will be randomly assigned to one of two groups. Aqueous 10% povidone iodine (PVI) solution will be used in each group, and the area of skin surrounding the planned surgical incision will be prepared. This is a routine standard of care in these patients, and the only difference between groups will be the method of application of the solution. Following induction of general anaesthesia participants in the intervention group will undergo surgical site skin antisepsis by spray-on application of aqueous PVI solution using a standard multipurpose spray applicator until all skin in the region of the planned surgical site is visibly coated with PVI (usually within one minute), and allowing to dry as recommended by the manufacturer. Regular education will be provided for all team members on the correct method of application, and details will be recorded in the operation note to ensure the method is being adhered to.

Sponsors

Chris O'Brien Lifehouse
Lead SponsorHospital

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

• Adult patients (18 years or older) • Undergoing elective open head and neck surgery (involving a skin incision)

Exclusion criteria

• Patients undergoing emergency surgery • Patients undergoing oral or transoral surgery where skin antisepsis would not usually be used • Patients with active skin infection • Patients with known allergy to any topical skin antisepsis agent • Patients with known immunosuppression • Patients taking systemic steroids • Patients not consenting to randomisation

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026