Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000114640
Ethics application status
Approved
Date submitted
29/12/2022
Date registered
3/02/2023
Date last updated
3/02/2023
Date data sharing statement initially provided
3/02/2023
Date results information initially provided
3/02/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does the use of intraoperative PVP-I (Povidone Iodine; Betadine) antiseptic wash in breast device surgery lower complication rates resulting in removal of the implants?
Scientific title
Intraoperative PVP-I (Povidone Iodine) antiseptic wash and complication rates in breast prosthesis surgery, analysis of observational Australian Breast Device Registry (ABDR) data
Secondary ID [1] 308682 0
NIL Known
Universal Trial Number (UTN)
Trial acronym
Linked study record
Leow, S.K. (2022) Contemporary Australian Trends in Antiseptic Pocket Rinse in Primary Breast Implant Surgery. Supervised by R.J. Knight. Dissertation, MS (Plast), University of Sydney

(This was a prior feasibility analysis study of ABDR data that constituted my MS thesis. The results show that ABDR data will make this trial that we are registering feasible.)

Health condition
Health condition(s) or problem(s) studied:
Post-operative infection 328609 0
Capsular Contracture 328610 0
Breast implant surgery 328821 0
Condition category
Condition code
Surgery 325619 325619 0 0
Surgical techniques
Surgery 325620 325620 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
2
Target follow-up type
Years
Description of intervention(s) / exposure
The intervention is the use of intraoperative betadine (Povidone-Iodine) pocket rinse.

All surgeons and hospital sites registered with the ABDR continue to report any implant-related surgeries to the ABDR on an ongoing basis. Follow-up/outcomes data are made up of explantation (removal of implant) surgeries made necessary by the respective post-operative complications.

All follow-up surgeries reported to the ABDR will be obtained up to 31 Dec 2022 from the ABDR, allowing for a 'rolling' minimum follow-up period of 2 years.

Patients are not required to do anything above their usual surgical treatment journey. The reporting of operative data is inherent in the ABDR national reporting processes.
Intervention code [1] 325297 0
Not applicable
Comparator / control treatment
Patients from the Australian Breast Device Registry (ABDR) where first device surgery occurred between 1 Jan 2015 to 31 Dec 2020 and intraoperative pocket rinse was not used during surgery
Control group
Active

Outcomes
Primary outcome [1] 333464 0
Deep infection requiring explantation as indicated by the operating surgeons in the ABDR data collection forms
Timepoint [1] 333464 0
Within first 30-60 days after primary breast implant surgery
Primary outcome [2] 333465 0
Capsular contracture requiring explantation as indicated by the operating surgeons in the ABDR data collection forms
Timepoint [2] 333465 0
Within first 18-24 months after primary breast implant surgery
Secondary outcome [1] 417187 0
Capsular contracture requiring explantation as indicated by the operating surgeons in the ABDR data collection forms
Timepoint [1] 417187 0
Any time from surgery to 2 years after primary breast implant surgery
Secondary outcome [2] 417188 0
Implant deflation or rupture requiring explantation as indicated by the operating surgeons in the ABDR data collection forms
Timepoint [2] 417188 0
Within first 18-24 months after primary breast implant surgery

Eligibility
Key inclusion criteria
Primary (First) Breast device surgery between 1 Jan 2015 to 31 Dec 2020 as reported to the ABDR
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Device revision surgeries
Tissue expander insertion
Tissue expander removal and implant insertion
Concurrent mastectomy
Axillary surgery including sentinel node biopsy
Concurrent flap cover

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis
Complete capture of national data from the national database was used to obtain the largest possible study population.
Logarithmic regression analysis will be required

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
24/09/2021
Date of last participant enrolment
Anticipated
Actual
24/09/2021
Date of last data collection
Anticipated
Actual
31/12/2022
Sample size
Target
30245
Accrual to date
Final
30245
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 23757 0
Waverley House Plastic Surgery Centre - Adelaide
Recruitment postcode(s) [1] 39202 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 312913 0
Self funded/Unfunded
Name [1] 312913 0
Sean Leow
Country [1] 312913 0
Australia
Primary sponsor type
Individual
Name
Robert Knight
Address
c/o Plastic Surgery Department
The Wollongong Hospital
Loftus Street
Wollongong NSW 2500
Country
Australia
Secondary sponsor category [1] 314591 0
None
Name [1] 314591 0
Not applicable
Address [1] 314591 0
Not applicable
Country [1] 314591 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312186 0
The University of Sydney Human Research Ethics Committee (HREC)
Ethics committee address [1] 312186 0
Research Integrity & Ethics Administration
Research Portfolio
Level 3, F23 Administration Building
The University of Sydney
NSW 2006 Australia
Ethics committee country [1] 312186 0
Australia
Date submitted for ethics approval [1] 312186 0
25/08/2021
Approval date [1] 312186 0
24/09/2021
Ethics approval number [1] 312186 0
2021/704

Summary
Brief summary
Evidence supports the use of intra-operative antiseptic rinse in breast implant surgery to minimize the risk of capsular contracture or other complications. However, there is limited consensus or standardization of antiseptic rinse in practice. Having already determined contemporary trends in antiseptic rinse use in primary breast device surgery in Australia, we will use observational Australian Breast Device Registry (ABDR) data to analyse antiseptic rinse effects on clinical outcomes.
Trial website
N/A
Trial related presentations / publications
Public notes
nil

Contacts
Principal investigator
Name 123778 0
Dr Robert Knight
Address 123778 0
c/o Plastic Surgery Department
The Wollongong Hospital
Loftus Street
Wollongong NSW 2500
Country 123778 0
Australia
Phone 123778 0
+610242388106
Fax 123778 0
Email 123778 0
dr.knight@ispaclinic.com.au
Contact person for public queries
Name 123779 0
Dr Sean Leow & Robert Knight
Address 123779 0
c/o Plastic Surgery Department
The Wollongong Hospital
Loftus Street
Wollongong NSW 2500
Country 123779 0
Australia
Phone 123779 0
+61024222 5000
Fax 123779 0
Email 123779 0
intraop.pvpi.rinse.study@gmail.com
Contact person for scientific queries
Name 123780 0
Dr Sean Leow & Robert Knight
Address 123780 0
c/o Plastic Surgery Department
The Wollongong Hospital
Loftus Street
Wollongong NSW 2500
Country 123780 0
Australia
Phone 123780 0
+61024222 5000
Fax 123780 0
Email 123780 0
intraop.pvpi.rinse.study@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Project and ethics approvals were obtained on condition that data remains de-identified and that access to the IPD is limited to the study personnel.
Deidentified data and IPD can be requested in future from the ABDR through similar project and ethics approval channels.


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.