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Trial registered on ANZCTR


Registration number
ACTRN12619001001189
Ethics application status
Approved
Date submitted
18/06/2019
Date registered
15/07/2019
Date last updated
15/07/2019
Date data sharing statement initially provided
15/07/2019
Date results information initially provided
15/07/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of a bundled care approach to preventing surgical site infections post caesarean section in an Australian Rural Hospital
Scientific title
Evaluation of a bundled care approach to preventing surgical site infections post caesarean section in an Australian Rural Hospital
Secondary ID [1] 298483 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
surgical site infection 313275 0
caesarean delivery 313276 0
Condition category
Condition code
Reproductive Health and Childbirth 311719 311719 0 0
Childbirth and postnatal care
Infection 311863 311863 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is comprised of a caesarean infection prevention "CIP" bundle that was developed and implemented across the study population. The CIP bundle had five elements including:
1) Identification of women at risk of surgical site infection (SSI) post caesarean section (CS)
- Antenatal identification and education administered by booking midwives and medical officers
2) Pre-operative site skin preparation protocol
- No shaving, clipping if required in the operating theatre by the medical officer
- Neutral detergent bed bath prior to CS administered by the attending midwife
3) Antibiotics prophylaxis administered pre-operatively
- Cephazolin 2g Intravenously 15-60 minutes before knife to skin administered by Anaesthetics
- Clindamycin 600mg Intravenously if known MRSA carrier or cephalosporin allergy
4) Operative site skin preparation
- 2% Chlorhexidine gluconate and 70% alcohol for skin preparation
- Applied by the attending medical officer or scrub nurse prior to surgical draping
5) Negative pressure wound therapy (NPWT) for Body Mass Index (BMI) > 35
- Applied intra-operatively and left on incision wound for 7 days
- Women with BMI < 35 have standard wound dressings applied

The intervention begins prior to surgery and concludes at the end of the surgical procedure or upon removal of negative pressure dressings at day 7 for women with a BMI over 35. Participants are followed up until 30 days post operatively. The intervention is the responsibility of all clinical midwives, obstetric medical staff, anaesthetics and the Infection Control Clinical Nurse Consultant (CNC). Surveillance and adherence data is collected using a multifaceted process including review of all patients undergoing CS in the study period, emergency department encounters and hospital admissions for wound complications within a 30 day post operative period.
Intervention code [1] 314746 0
Prevention
Comparator / control treatment
The control group include all women undergoing CS at the enlisted facility in the 12 month period prior to the intervention; from December 2016 to December 2017. The control group had caesareans performed:
- Without neutral detergent bed bath
- Using Povidone-iodine skin preparation
- With antibiotic administration intra-operatively without a standardised approach
- With no negative pressure wound therapy for high BMI patients
Control group
Historical

Outcomes
Primary outcome [1] 320417 0
The rate of CS SSI, as defined by the CDC diagnostic criteria, following the implementation of the the CIP bundle. The CDC diagnostic criteria requires infection to occur within 30 days of the procedure AND involves the skin, subcutaneous tissue or deeper AND at least one of the following:
- Purulent drainage from the superficial incision
- Organisms identified from an aseptically-obtained specimen from the incision or subcutaneous tissue by culture or non-culture based microbiologic testing which is performed for the purposes of clinical treatment
- Superficial incision that is opened by a surgeon or attending physician and culture based testing is not performed AND the patient has one of localised pain, tenderness, swelling , erythema or heat
Timepoint [1] 320417 0
The outcome is assessed at 30 days or at the point of admission for review or treatment of SSI prior to 30 days.
Secondary outcome [1] 371524 0
Assess adherence to infection prevention protocols within the enlisted service. This is performed by reviewing medical records of study participants.
Timepoint [1] 371524 0
30 days post CS

Eligibility
Key inclusion criteria
All women undergoing CS 12 months prior to implementation of the Bundle and all women undergoing CS 12 months post implementation of the bundle
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
There are no exclusion criteria in this study

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed. This is a translational research project where the CIP bundle is implemented as routine practice.
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
retrospective data was collected on all women delivering via Caesarean Section in the 12 month period directly prior to implementation of the bundled intervention
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Univariate analyses will be conducted to assess for differences in the populations in the pre and post intervention groups. Univariate analyses will be conducted to test for differences in demographic and comorbidity variables or interest, between those that develop SSI and those that do not. CS and SSI rates will be compared pre and post intervention using t-tests and logistic regression models. The non-parametric Wilcoxon rank sum test will be used where there are small numbers of observations.

Recruitment
Recruitment status
Completed
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] 13998 0
Tamworth Rural Referral Hospital - Tamworth
Recruitment postcode(s) [1] 26777 0
2340 - Tamworth

Funding & Sponsors
Funding source category [1] 303028 0
Self funded/Unfunded
Name [1] 303028 0
Address [1] 303028 0
Country [1] 303028 0
Primary sponsor type
Hospital
Name
Tamworth Regional Referral Hospital - Tamworth
Address
Corner of Dean Street and Johnson Street
North Tamworth, NSW 2340
Country
Australia
Secondary sponsor category [1] 303259 0
None
Name [1] 303259 0
Address [1] 303259 0
Country [1] 303259 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303577 0
Hunter New England Health District Human Research Ethics Committee
Ethics committee address [1] 303577 0
Locked bag 1
Hunter Region Mail Centre
Newcastle, NSW, 2300
Ethics committee country [1] 303577 0
Australia
Date submitted for ethics approval [1] 303577 0
17/01/2018
Approval date [1] 303577 0
16/04/2018
Ethics approval number [1] 303577 0
169133

Summary
Brief summary
Elective and non-elective caesarean section (CS) rates have been increasing in Australia over the past 20 years. Increasing antenatal morbidity, has meant that surgical site infection (SSI) post CS is an important issue effecting Australian women. Populations most impacted include low socioeconomic and regional communities where high rates of antenatal comorbidity augment the incidence of SSI. Despite a recent trend towards supporting the development of evidence based bundled approaches to SSI reduction, there remains paucity in data proving efficacy and supporting bundle implementation.

This study aimed to develop, implement and assess an evidence based caesarean infection prevention “CIP” bundled intervention to reduce SSI rates following CS in a high risk rural population.

The study is a pre-post intervention study with 3 phases and included all women undergoing CS at a regional referral hospital between December 1st 2016 and December 31st 2018. A 12 month retrospective pre-intervention review identified all women who developed a post CS SSI. A comprehensive literature review informed the development of the intervention, which was implementation in December 2017. Prospective data collection for a subsequent 12 month period was collected on all women who underwent CS with pre and post comparative data analysis.
Trial website
Trial related presentations / publications
Public notes
This project was an implementation project involving embedded practice change within a whole service. No formal recruitment was required as all patients undergoing CS received the "CIP" bundle of care once the practice change was implemented. Ethics approval was for the formal evaluation and involved retrospective data collection of the pre implementation group.

Contacts
Principal investigator
Name 94146 0
Mrs Michelle Bolte
Address 94146 0
Tamworth Rural Referrral Hospital
Corner of Dean and Johnson St, North Tamworth NSW 2340
Country 94146 0
Australia
Phone 94146 0
+61 2 67677185
Fax 94146 0
Email 94146 0
michelle.bolte@health.nsw.gov.au
Contact person for public queries
Name 94147 0
Mrs Michelle Bolte
Address 94147 0
Tamworth Rural Referrral Hospital
Dean St, North Tamworth NSW 2340
Country 94147 0
Australia
Phone 94147 0
+61 2 67677185
Fax 94147 0
Email 94147 0
michelle.bolte@health.nsw.gov.au
Contact person for scientific queries
Name 94148 0
A/Prof Michelle Giles
Address 94148 0
Hunter New England Health
Nursing and Midwifery Research Centre
Gate Cottage
72 Watt Street Newcastle, 2300
NSW
Country 94148 0
Australia
Phone 94148 0
+61 0457710429
Fax 94148 0
Email 94148 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
Data accessible to research team only
What supporting documents are/will be available?
Ethical approval
How or where can supporting documents be obtained?
Type [1] 2364 0
Ethical approval
Citation [1] 2364 0
Link [1] 2364 0
Email [1] 2364 0
Other [1] 2364 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary
This study aimed to develop, implement and evaluate an evidence based caesarean infection prevention “CIP” bundled intervention to reduce surgical site infection rates following caesarean section delivery in a high risk rural population.
The study was a pre-post-intervention study
Results
A total of 710 procedures were monitored as part of the study with 346 and 364 women in the pre and post-intervention groups respectively. Rates of caesarean section associated surgical site infection reduced significantly post-intervention from 5.5% to 1.6%, the greatest benefit seen in class II and III obese patients where rates reduced from 12.2% pre intervention to 2.5% post implementation of the intervention.