ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12622000059763

Ethics application status

Approved

Date submitted

2/12/2021

Date registered

18/01/2022

Date last updated

16/11/2023

Date data sharing statement initially provided

18/01/2022

Type of registration

Prospectively registered

Titles & IDs

Public title

Spray application of skin antisepsis in head and neck surgery

Scientific title

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

Secondary ID [1]

nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

surgical site infection

Condition category

Condition code

Surgery

Other surgery

Infection

Studies of infection and infectious agents

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

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.

Intervention code [1]

Prevention

Comparator / control treatment

Participants in the control group will undergo skin antisepsis by application of the same solution (10% PVI) by painting with a sterile gauze swab 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.

Control group

Active

Outcomes

Primary outcome [1]

post operative surgical site infection as defined by CDC criteria:

For superficial surgical site infection:

Event within 30 days of procedure
AND
Involves only the skin and subcutaneous tissue of the incision site
AND
Patient has at least one of:
a. purulent drainage from the superficial incision
b. organism(s) identified from an aseptically-obtained specimen from the superficial incision or subcutaneous tissue by a culture or nonculture based microbiologic testing method which is performed for purposes of clinical diagnosis or treatment.
c. superficial incision that is deliberately opened by a surgeon or physician and culture or non-culture-based testing of the superficial incision or subcutaneous tissue is not performed
AND
patient has at least one of the following signs or symptoms:
localized pain or tenderness; localized swelling; erythema; or
heat.
For deep surgical site infection:

Event within 30 days of procedure
AND
Involves deep soft tissues of the incision
AND
a. purulent drainage from the deep incision.
b. a deep incision that spontaneously dehisces, or is deliberately opened or aspirated by a surgeon or physician
AND
organism(s) identified from the deep soft tissues of the incision by a culture or non-culture based microbiologic testing method which is performed for purposes of clinical diagnosis or treatment
AND
patient has at least one of the following signs or symptoms: fever (>38°C); localized pain or tenderness.
c. an abscess or other evidence of infection involving the deep incision that is detected on gross anatomical or histopathologic exam, or imaging test.

Timepoint [1]

7 days and 30 days post surgery

Secondary outcome [1]

Adverse effects including localised skin reaction and allergic reaction will be assessed from the medical records.

Localised skin reaction is defined by erythema, blistering and rash at the treated site with no criteria for surgical site infection.

Systemic allergic reaction is defined by tachycardia as recorded by electrocardiography, dyspnoea as reported by patients, and anaphylaxis defined as rapid onset multiple organ dysfunction as a result of hypersensitivity to an exogenous agent.

Timepoint [1]

7 days and 30 days post surgery

Eligibility

Key inclusion criteria

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

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key 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

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 phone/fax/computer

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Stratified allocation using computer generated randomisation. Participants will be stratified according to:

1. History of a formal diagnosis of diabetes mellitus
2. History prior radiotherapy to the surgical site

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

All randomised participants will be included in statistical analysis. Chi squared analysis will be used to test the statistical significance of any difference in the rate of SSI between the two groups, with a level of significance of 5%. To satisfy the noninferiority hypothesis, the upper bound of the one-sided 95% confidence interval for the rate of SSI with spray application needs to be no more than 5% higher than the rate of SSI with paint application. Based on institutional pilot data, the SSI rate in the control arm is anticipated to be 9%. The only other trial investigating spray-on skin antisepsis identified a difference of 2% in SSI rate between spray-on and paint-on arms in favour of the former. Thus, estimating a rate of SSI in the intervention arm of 7%, allowing for a 1% drop-out rate and assuming a 1:1 case to control ratio, 376 patients are required to establish non-inferiority of spray-on PVI with 80% power and a 5% level of statistical significance.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

28/01/2022

Actual

5/05/2022

Date of last participant enrolment

Anticipated

1/06/2022

Actual

1/12/2022

Date of last data collection

Anticipated

1/07/2022

Actual

31/12/2022

Sample size

Target

418

Accrual to date

Final

432

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Chris O’Brien Lifehouse - Camperdown

Recruitment postcode(s) [1]

2050 - Camperdown

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Chris O'Brien Lifehouse

Address [1]

119-143 Missenden Road
Camperdown
NSW 2050

Country [1]

Australia

Primary sponsor type

Hospital

Name

Chris O'Brien Lifehouse

Address

119-143 Missenden road
Camperdown
NSW 2050

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

St Vincents Hospital human research ethics committee

Ethics committee address [1]

390 Victoria street
Darlinghurst
NSW 2010

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

10/01/2022

Approval date [1]

23/03/2022

Ethics approval number [1]

2021/ETH12112

Summary

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.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Jonathan Clark

Address

Chris O'Brien Lifehouse
119-143 Missenden Road
Camperdown
NSW
2050

Country

Australia

Phone

+61 0285140268

Fax

jonathan.clark@lh.org.au

Contact person for public queries

Name

Jonathan Fussey

Address

Chris O'Brien Lifehouse
119-143 Missenden Road
Camperdown
NSW
2050

Country

Australia

Phone

+61 0285140000

Fax

jfussey@nhs.net

Contact person for scientific queries

Name

Jonathan Fussey

Address

Chris O'Brien Lifehouse
119-143 Missenden Road
Camperdown
NSW
2050

Country

Australia

Phone

+61 0285140000

Fax

jfussey@nhs.net

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
14312	Study protocol					383220-(Uploaded-02-12-2021-09-52-30)-Study-related document.docx
14313	Informed consent form					383220-(Uploaded-02-12-2021-09-52-38)-Study-related document.docx

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.

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