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Trial registered on ANZCTR


Registration number
ACTRN12620001233910
Ethics application status
Approved
Date submitted
22/09/2020
Date registered
18/11/2020
Date last updated
18/11/2020
Date data sharing statement initially provided
18/11/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Tracking surgical site infection post caesarean section through HealthTracker
Scientific title
Tracking surgical site infection post caesarean section through post hospital discharge surveillance
Secondary ID [1] 302341 0
Nil known
Universal Trial Number (UTN)
U1111-1258-3822
Trial acronym
HealthTracker: HealthTracker Surgical Site Infection Surveillance
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Surgical site Infections 319113 0
Caesarean section 319114 0
Condition category
Condition code
Surgery 317074 317074 0 0
Other surgery
Infection 317075 317075 0 0
Studies of infection and infectious agents
Reproductive Health and Childbirth 317404 317404 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The HealthTracker SSI surveillance
The women who give a live birth will receive an SMS invitation to complete a wound healing questionnaire via HealthTracker on day 30 of CS. At the end of the questionnaire, they will be asked to completed a feedback survey about the use of HealthTracker. it will take less than 10 minutes to complete both if they choose to complete.
The research team via HealthTracker will send an automated SMS invitation women linking women their unique ID which is generated by using their MRNs.
Uptake and acceptability of the Healthtracker will be monitored by the team through a regular report
Intervention code [1] 318633 0
Early detection / Screening
Comparator / control treatment
Control group: baseline data will be collected from the John Hunter Hospital Patient Management System from 1/October 2010- 31/ May 2020.
Control group
Historical

Outcomes
Primary outcome [1] 325165 0
Rate of patient reported surgical site infections:
SSI rates will be identified from a combination of data sources from HealthTracker questionnaire, Patient Management system ED presentations and readmissions and contact with GPs.
Timepoint [1] 325165 0
30 days post caesarean section
Secondary outcome [1] 387053 0
The uptake of the Wound Health Questionnaire via HealthTracker: This outcome will be monitored by Healthtracker generated report


Timepoint [1] 387053 0
At the completion of the study
Secondary outcome [2] 387965 0
Acceptability of HealthTracker by response rates, enablers and barriers, including feedback from women with Aboriginal and culturally and linguistically diverse backgrounds by HealthTracker generated report and the feedback survey.
Timepoint [2] 387965 0
During the study period and at the completion of the study

Eligibility
Key inclusion criteria
All women giving birth to a live baby by CS at John Hunter Hospital over a 6-month period.
Minimum age
14 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women with a stillbirth

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
The historical control data( baseline data) will be used to compare the SSI rates against the Post Intervention data.
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
The estimated number of eligible women in 6 months is 700 (CS rate: 34% of 4000 births annually). HealthTracker questionnaire data will be merged with hospital inpatient information systems data into a centralised data repository. Data analysis will include calculation of SSI rates. Differences in SSI rates between current surveillance methods and HealthTracker will be analysed. Descriptive statistics will be completed on the Acceptability Survey.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 17553 0
John Hunter Hospital - New Lambton
Recruitment postcode(s) [1] 31288 0
2305 - New Lambton

Funding & Sponsors
Funding source category [1] 306770 0
Government body
Name [1] 306770 0
Hunter New England Local Health District Improvement Grant
Address [1] 306770 0
Hunter New England Research Office, Level 3 POD,
Hunter Medical Research Institute, , Lot 1, Kookaburra Circuit, New Lambton Heights, NSW, 2305.

Country [1] 306770 0
Australia
Primary sponsor type
Government body
Name
Hunter New England Local Health District Nursing and Midwifery Research Centre
Address
James Fletcher Campus, Gate Cottage, 72 Watt Street, Newcastle NSW 2300
Country
Australia
Secondary sponsor category [1] 307323 0
Government body
Name [1] 307323 0
John Hunter Hospital Maternity Service
Address [1] 307323 0
Lookout Road, Lambton Heights, NSW 2305
Country [1] 307323 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306936 0
Hunter New England Local Health District Human Ethics Commitee
Ethics committee address [1] 306936 0

Hunter New England Research Office, Level 3 POD,
Hunter Medical Research Institute, , Lot 1, Kookaburra Circuit, New Lambton Heights, NSW, 2305.
Ethics committee country [1] 306936 0
Australia
Date submitted for ethics approval [1] 306936 0
31/08/2020
Approval date [1] 306936 0
15/09/2020
Ethics approval number [1] 306936 0
2020/ETH02218

Summary
Brief summary
Caesarean section (CS) is one of the most common surgeries in Australia. Women who undergo a CS are at risk of surgical site infections (SSI), and post-CS SSI is associated with substantial maternal morbidity and healthcare costs, and can lead to significant physical and emotional burden for mothers. Despite this burden, no standardised CS SSI surveillance mechanism or mandatory reporting system exists, and CS SSI may therefore be undetected. This project will address the gap in surveillance through trialling an electronic wound healing questionnaire via an app called, HealthTracker. Acceptability of the survey will be evaluated through the response rate of the women, and a feedback questionnaire. Data from HealthTracker will enable post-CS SSI rates to be monitored post discharge from hospital in order to identify true infection rates and to inform decision making related to preventative strategies.
Trial website
https://www.healthtracker.net.au/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 105506 0
A/Prof Michelle Giles
Address 105506 0
HNE Nursing and Midwifery Research Centre

James Fletcher Campus, Gate Cottage, 72 Watt Street, Newcastle NSW 2300
Country 105506 0
Australia
Phone 105506 0
+61 2 49246702
Fax 105506 0
Email 105506 0
michelle.giles@health.nsw.gov.au
Contact person for public queries
Name 105507 0
A/Prof Michelle Giles
Address 105507 0
HNE Nursing and Midwifery Research Centre

James Fletcher Campus, Gate Cottage, 72 Watt Street, Newcastle NSW 2300
Country 105507 0
Australia
Phone 105507 0
+61 2 49246702
Fax 105507 0
Email 105507 0
michelle.giles@health.nsw.gov.au
Contact person for scientific queries
Name 105508 0
A/Prof Michelle Giles
Address 105508 0
HNE Nursing and Midwifery Research Centre

James Fletcher Campus, Gate Cottage, 72 Watt Street, Newcastle NSW 2300
Country 105508 0
Australia
Phone 105508 0
+61 2 49246702
Fax 105508 0
Email 105508 0
michelle.giles@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The information is health record information that can not be publically shared, therefore, the de-identified individual participant data will not be available for this study.

Any information will be de-identified at the report and publications.
What supporting documents are/will be available?
No other documents available
Summary results
No Results