Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000021572
Ethics application status
Approved
Date submitted
3/12/2014
Date registered
15/01/2015
Date last updated
12/04/2019
Date data sharing statement initially provided
12/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of surgical skin preparations on post-operative skin infections in patients having surgical procedures
Scientific title
A Randomised Clinical Trial in Participants Undergoing Incisional Surgery, to Assess the Efficacy of Surgical Skin Preparation: A Three-armed Comparison of Chlorhexidine versus Povidone-iodine Preparations
Secondary ID [1] 284365 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Surgical site infection 291528 0
Condition category
Condition code
Infection 291901 291901 0 0
Studies of infection and infectious agents
Surgery 291902 291902 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
2% Chlorhexidine + 70% alcohol
10% Povidone-iodine + 70% alcohol
10% Aqueous Povidone-iodine
Intervention code [1] 289094 0
Treatment: Drugs
Comparator / control treatment
10% Povidone-iodine+70% alcohol
10% aqueous povidone-iodine
2% Chlorhexidine + 70% alcohol

Control group
Active

Outcomes
Primary outcome [1] 291819 0
The surgical site infection rate as determined by the objective and subjective parameters defined by the Center for Disease Control (CDC) USA criteria for SSI 2015.
Timepoint [1] 291819 0
All patients will be reviewed at day 30 post-operatively for superficial surgical site infection.
Secondary outcome [1] 307608 0
Hypersensitivity reaction rate assessed by observation by nursing and/or medical staff for skin irritation, redness, swelling within 24 hours of surgery.
Timepoint [1] 307608 0
within 24 hours of surgery
Secondary outcome [2] 311703 0
Total surgical complication rate (Clavien Dindo score)
Timepoint [2] 311703 0
Day 30 for superficial SSI for all participants with surveillance to 90 days for deep organ/space SSI for a subgroup of patients.
Secondary outcome [3] 311704 0
Length of Hospital Stay as assessed from medical record admission and discharge dates.
Timepoint [3] 311704 0
Date of discharge from surgical services.
Secondary outcome [4] 311705 0
Readmission rate, as assessed by number of patients readmitted to hospital for management of a post-operative surgical site infection.
Timepoint [4] 311705 0
Day 30 for superficial SSI for all participants with surveillance to 90 days for deep organ/space SSI for a subgroup of patients.

Eligibility
Key inclusion criteria
All patients undergoing elective or semi-urgent incisional surgery requiring skin preparation, that have provided written informed consent and are aged 18 years and over.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded if they:
-Refuse or are unable to give written informed consent to participate in the study, or
-are under 18 years of age, or
-have a history of allergy to iodophors
-have a current infection at, or adjacent to the operative site
-have current evidence of generalised sepsis
-screen positive for MRO (Multi Resistant Organism)
-unable to attend routine follow-up appointments
-previous participation in this study

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)
After screening for eligibility and written informed consent has been provided, randomisation will be performed in the operating theatre on the day of surgery via a web-based randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be computer generated in random blocks for each stratum in a 1:1:1 ratio.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
This three-armed trial examines the following aims regarding prevention of SSI:
1. The non-inferiority (followed by potential superiority) of povidone-iodine + 70% ethanol compared with chlorhexidine 0.5% + 70% ethanol.
2. The superiority of povidone-iodine + 70% ethanol compared to 10% aqueous povidone-iodine.
NB from 12 December 2016 the Chlorhexidine arm will change to a 2% concentration with 70% alcohol.
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
This trial will be structured with two comparisons driving the sample size, statistical power and non-inferiority margin. The first comparison will be an non-inferiority trial between the chlorhexidine+alcohol and povidone-iodine+alcohol preparations. Using an expected rate of infection of 15% in the povidone-iodine+alcohol arm, a clinically significant difference in infection that would influence the choice between the 2 preparations is 4% (non-inferiority margin). This would be demonstrable with 80% power and 95% significance with 990 patients in each arm. If this number is used for the third arm of the trial (10% aqueous povidone-iodine vs 10% povidone-iodine +70% alcohol solution) it would provide sufficient power to detect a difference of 5% (i.e. 15% in povidone-iodine chlorhexidine+alcohol and 20% in the aqueous povidone-iodine group), in line with the effect described in the largest previous trial (Darouiche et al) at a power of 80% and 95% significance. Hence, we propose a recruitment target of 2970, which implies 3300 to be recruited to allow for approximately 10% dropout.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2015
Actual
7/07/2015
Date of last participant enrolment
Anticipated
Actual
19/09/2018
Date of last data collection
Anticipated
Actual
6/03/2019
Sample size
Target
3300
Accrual to date
Final
3301
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 3230 0
John Hunter Hospital Royal Newcastle Centre - New Lambton
Recruitment hospital [2] 3231 0
Newcastle Private Hospital - New Lambton Heights
Recruitment postcode(s) [1] 9012 0
2305 - New Lambton Heights

Funding & Sponsors
Funding source category [1] 290344 0
Hospital
Name [1] 290344 0
John Hunter Hospital
This projected will be funded internally at John Hunter hospital via departmental research fund.
Country [1] 290344 0
Australia
Funding source category [2] 290345 0
Hospital
Name [2] 290345 0
Newcastle Private Hospital
Country [2] 290345 0
Australia
Funding source category [3] 291457 0
University
Name [3] 291457 0
University of Newcastle
Hunter Medical Research Institute
Country [3] 291457 0
Australia
Primary sponsor type
Hospital
Name
John Hunter Hospital
Address
Lookout Road
New Lambton Heights
New South Wales 2305
Country
Australia
Secondary sponsor category [1] 289066 0
Hospital
Name [1] 289066 0
Newcastle Private Hospital
Address [1] 289066 0
Lookout Road
New Lambton Heights
New South Wales 2305
Country [1] 289066 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292048 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 292048 0
Ethics committee country [1] 292048 0
Australia
Date submitted for ethics approval [1] 292048 0
Approval date [1] 292048 0
07/11/2014
Ethics approval number [1] 292048 0
13/12/11/3.02

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 256 256 0 0
/AnzctrAttachments/366083-Ethics Approval.pdf

Contacts
Principal investigator
Name 47390 0
A/Prof Stephen Smith
Address 47390 0
Surgical Services
John Hunter Hospital
Locked Bag 1
Hunter Region Mail Centre
New South Wales 2310
Country 47390 0
Australia
Phone 47390 0
+61 2 49855153
Fax 47390 0
Email 47390 0
[email protected]
Contact person for public queries
Name 47391 0
Rosemary Carroll
Address 47391 0
Surgical Services
John Hunter Hospital
Locked Bag 1
Hunter Region Mail Centre
New South Wales 2310
Country 47391 0
Australia
Phone 47391 0
+61 249855153
Fax 47391 0
Email 47391 0
[email protected]
Contact person for scientific queries
Name 47392 0
Stephen Smith
Address 47392 0
Surgical Services
John Hunter Hospital
Locked Bag 1
Hunter Region Mail Centre
New South Wales 2310
Country 47392 0
Australia
Phone 47392 0
+61 2 49855153
Fax 47392 0
Email 47392 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
cleaned data that was submitted for analysis
When will data be available (start and end dates)?
Yet to be determined and will update when information available.
Available to whom?
relevant researchers
Available for what types of analyses?
meta-analyses
How or where can data be obtained?
Contact to CI via email.


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
SourceTitleYear of PublicationDOI
EmbaseAntiseptic Skin Preparation Agents to Prevent Surgical Site Infection in Colorectal Surgery: A 3-Armed Randomized Controlled Trial.2022https://dx.doi.org/10.1097/DCR.0000000000002171
N.B. These documents automatically identified may not have been verified by the study sponsor.