Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000379910
Ethics application status
Approved
Date submitted
12/04/2011
Date registered
12/04/2011
Date last updated
11/07/2019
Date data sharing statement initially provided
11/07/2019
Date results information initially provided
11/07/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Betadine Trial -Does use of Betadine solution to wound prior to closure of skin at caesarean section affect wound healing and or infection after caesarean section
Scientific title
Does use of Betadine solution to wound prior to closure of skin at caesarean section affect wound healing and or infection after caesarean section
Secondary ID [1] 259984 0
Nil
Universal Trial Number (UTN)
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post caesarean section wound healing and sepsis 265608 0
Condition category
Condition code
Infection 265755 265755 0 0
Studies of infection and infectious agents
Surgery 265758 265758 0 0
Surgical techniques
Reproductive Health and Childbirth 265759 265759 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
prior to closure of skin at caesarean section women will be randomised to betadine or no betadine soak of the wound.
20 mls of betadine solution is poured onto the incision site prior to skin closure and skin closed as normal practice within 30 seconds.
Intervention code [1] 264397 0
Prevention
Intervention code [2] 264398 0
Treatment: Other
Comparator / control treatment
No betadine
Control group
Active

Outcomes
Primary outcome [1] 266513 0
Wound infection within 6 weeks of delivery - this will be by phone contact and or a letter - currently this is the routine practice by the infection control unit for all c/sections.
Chart audit if admitted to hospital
Timepoint [1] 266513 0
6 weeks post partum
Secondary outcome [1] 273933 0
Wound healing -phone interview or lettter and chart audit if admitted to hospital
Timepoint [1] 273933 0
6 weeks

Eligibility
Key inclusion criteria
all women having caesarean section
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
nil

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)
stratified by elective c/section or c/section in labour
consecutively numbered opaque envelopes containing the allocation will be in theatre and will only be opened immediately prior to skin closure
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
random number table with block of 10
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
nil
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2009
Actual
1/04/2010
Date of last participant enrolment
Anticipated
Actual
30/04/2014
Date of last data collection
Anticipated
Actual
30/06/2014
Sample size
Target
3000
Accrual to date
Final
3304
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 264859 0
Self funded/Unfunded
Name [1] 264859 0
Country [1] 264859 0
Australia
Funding source category [2] 264863 0
Self funded/Unfunded
Name [2] 264863 0
kassam mahomed
Country [2] 264863 0
Australia
Primary sponsor type
Individual
Name
Kassam mahomed
Address
Dept of obstetrics
chelmsford Avenue
Ipswich Hospital Ipswich qld 4305
Country
Australia
Secondary sponsor category [1] 263958 0
None
Name [1] 263958 0
Address [1] 263958 0
Country [1] 263958 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266822 0
Darling Downs and West Morton health Service district DWMHSD HREC
Ethics committee address [1] 266822 0
The Park - centre for mental health
Ellerton Road
Wacol
Qld 4074
Ethics committee country [1] 266822 0
Australia
Date submitted for ethics approval [1] 266822 0
12/08/2009
Approval date [1] 266822 0
15/10/2009
Ethics approval number [1] 266822 0
47-09

Summary
Brief summary
Infection after c/section is a concern for women and health workers. Prophylactic antibiotics are used to prevent infection but some will still develop the complication. betadine is routinely used for skin preparation prior to c/section. It is believed that its use again immediately prior to skin closure may further reduce the infection rate.
This is an open randomsied controlled trial. Hospital infection control dept routinely make contact with all c/section women. This source will be used to gather information on women who develop any problem with ht ewound. They routinely provide consent to be contacted for this purpose and therefore no additional consent will be required .
Trial website
nil
Trial related presentations / publications
nil yet
Public notes

Contacts
Principal investigator
Name 32475 0
A/Prof kassam mahomed
Address 32475 0
Dept of Obstetrics and Gynaecology
Ipswich Hospital
1 Chelmsford ave
Ipswich
qld
4305
Country 32475 0
Australia
Phone 32475 0
+61 407034283
Fax 32475 0
Email 32475 0
[email protected]
Contact person for public queries
Name 15722 0
A/Prof A/Professor Kassam Mahomed
Address 15722 0
Chelmsford Avenue
Dept of Obstetrics
Ipswich Hospital Ipswich qld 4305
Country 15722 0
Australia
Phone 15722 0
+61 407034283
Fax 15722 0
+61 7 38101598
Email 15722 0
[email protected]
Contact person for scientific queries
Name 6650 0
A/Prof A/Professor Kassam Mahomed
Address 6650 0
chelmsford Avenue
Dept of Obstetrics
Ipswich Hospital Ipswich qld 4305
Country 6650 0
Australia
Phone 6650 0
+61 407034283
Fax 6650 0
+61 7 38101598
Email 6650 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?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes The Betadine trial – antiseptic wound irrigation p... [More Details] 336797-(Uploaded-10-07-2019-13-57-14)-Journal results publication.pdf

Documents added automatically
No additional documents have been identified.