Trial Review

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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] 305933 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
surgical site infection 324527 0
Condition category
Condition code
Surgery 321994 321994 0 0
Other surgery
Infection 322260 322260 0 0
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] 322326 0
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] 329749 0
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] 329749 0
7 days and 30 days post surgery
Secondary outcome [1] 403654 0
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] 403654 0
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?
No
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] 21242 0
Chris O’Brien Lifehouse - Camperdown
Recruitment postcode(s) [1] 36115 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 310274 0
Hospital
Name [1] 310274 0
Chris O'Brien Lifehouse
Country [1] 310274 0
Australia
Primary sponsor type
Hospital
Name
Chris O'Brien Lifehouse
Address
119-143 Missenden road
Camperdown
NSW 2050
Country
Australia
Secondary sponsor category [1] 311379 0
None
Name [1] 311379 0
Address [1] 311379 0
Country [1] 311379 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309945 0
St Vincents Hospital human research ethics committee
Ethics committee address [1] 309945 0
Ethics committee country [1] 309945 0
Australia
Date submitted for ethics approval [1] 309945 0
10/01/2022
Approval date [1] 309945 0
23/03/2022
Ethics approval number [1] 309945 0
2021/ETH12112

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 115938 0
Prof Jonathan Clark
Address 115938 0
Chris O'Brien Lifehouse
119-143 Missenden Road
Camperdown
NSW
2050
Country 115938 0
Australia
Phone 115938 0
+61 0285140268
Fax 115938 0
Email 115938 0
[email protected]
Contact person for public queries
Name 115939 0
Jonathan Fussey
Address 115939 0
Chris O'Brien Lifehouse
119-143 Missenden Road
Camperdown
NSW
2050
Country 115939 0
Australia
Phone 115939 0
+61 0285140000
Fax 115939 0
Email 115939 0
[email protected]
Contact person for scientific queries
Name 115940 0
Jonathan Fussey
Address 115940 0
Chris O'Brien Lifehouse
119-143 Missenden Road
Camperdown
NSW
2050
Country 115940 0
Australia
Phone 115940 0
+61 0285140000
Fax 115940 0
Email 115940 0
[email protected]

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14312Study protocol    383220-(Uploaded-02-12-2021-09-52-30)-Study-related document.docx
14313Informed 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.