Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000343808
Ethics application status
Approved
Date submitted
7/01/2021
Date registered
25/03/2021
Date last updated
7/03/2022
Date data sharing statement initially provided
25/03/2021
Date results provided
7/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The PICS Project -Prevention of Infection after Caesarean Section
Scientific title
The PICS Project (Prevention of Infection after Caesarean Section): The effect of a peri-operative bundle on the incidence of infection following Caesarean section at National Women’s, Auckland City Hospital, New Zealand.
Secondary ID [1] 303119 0
None
Universal Trial Number (UTN)
U1111-1235-3968
Trial acronym
PICS
Linked study record
NA

Health condition
Health condition(s) or problem(s) studied:
Post-Caesarean infection 320215 0
Condition category
Condition code
Reproductive Health and Childbirth 318152 318152 0 0
Childbirth and postnatal care
Infection 318153 318153 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two continuous cohorts each of three months duration. From the date of the trial commencing, patients undergoing Caesarean section will undergo routine care for three months (pre-implementation group)
There will then be a four week/one month period of introduction of the intervention. Data during this time will NOT be collected.
The subsequent three months, all patients undergoing Caesarean section will receive the bundled interventions described.
For patients in the post-implementation group:
1) Vaginal aseptic cleansing prior to skin incision for all caesarean sections, including cleaning the vulva and perineum with gauze wetted with 2% chlorhexidene gluconate/70% iso alcohol solution (Theatre nursing staff/surgeon)
2) Complete coverage of the incisional area prior to skin incision with 2% chlorhexidine gluconate/70% iso-alcohol solution. Minimum of two minutes contact time; must be allowed to air dry, no cloths or towels used to dry the skin. (surgeon)
3) Cefazolin 2g (if <120kg)/3g (if >120kg) given intravenously prior to skin incision- weight-based regime. Repeat dose if EBL >1500ml or operating time over three hours; included in WHO Time Out. (Anaesthetist)
4) Before closing rectus fascia, remove or change one pair of surgical gloves (surgeon prompted by scrub nurse)
5) Assessment of normothermia - pre-operative and post-operative temperature checks within range 36.5-37.5 degrees Celsius. Active rewarming with warmed blankets and 3M BairHugger device when pre-operative temperature below 36 degrees. No temperature assessments will be made in theatre.

Cohort of all patients over a three month period undergoing Caesarean section.
Intervention code [1] 319417 0
Prevention
Comparator / control treatment
Comparator group are a cohort of patients undergoing caesarean delivery who undergo routine care as per departmental guidelines: Auckland District Health Board Caesarean Section (CS) – Pre, Peri & Post-Op Care. Unique identifier NMP200/SSM/016
For this group, there will be no change of surgical gloves prior to closure of the rectus sheath. Staff will not be prompted to perform vulvo-vaginal antiseptic cleansing and there will be no requirement to wait for skin antiseptic solution to dry for two minutes.
Control group
Active

Outcomes
Primary outcome [1] 326142 0
primary outcome will be surgical site infection, a composite of wound infection, cellulitis, haematoma or seroma, endometritis or any deep pelvic space infection, with a need for antibiotic treatment. The diagnosis of surgical site infection will be made clinically.
Timepoint [1] 326142 0
28 days post operative
Secondary outcome [1] 390234 0
Readmission to hospital assessed by following patient electronic medical records for 28 days
Timepoint [1] 390234 0
28 days post operative
Secondary outcome [2] 390235 0
Length of hospital stay assessed by following patient electronic medical records for 28 days
Timepoint [2] 390235 0
28 days post operative
Secondary outcome [3] 390236 0
Need for intravenous antibiotics assessed by following patient electronic medical records for 28 days
Timepoint [3] 390236 0
28 days post operative
Secondary outcome [4] 390237 0
Need for additional wound care outside normal parameters assessed by following patient electronic medical records for 28 days
Timepoint [4] 390237 0
28 days post operative

Eligibility
Key inclusion criteria
Patients having a Caesarean section at Auckland City Hospital
Minimum age
15 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
None

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)
NOT APPLICABLE
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
Two cohort of patients consecutively for six months. First co-hort pre-intervention/routine care, second cohort post-intervention.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A 50% reduction in the rate of post-operative infection would be considered clinically significant. There is a paucity of recent data in the department regarding post-operative complications after caesarean section. Data on the effect of the introduction of vulvovaginal cleansing on rates of endometritis showed a reduction in incidence from 6% to 2%. Extrapolating this data, for a two-thirds reduction and using a p-value<0.05 for significance, the total sample size required is 752, with 376 patients in each cohort.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
5/04/2021
Actual
3/05/2021
Date of last participant enrolment
Anticipated
31/10/2021
Actual
28/11/2021
Date of last data collection
Anticipated
31/03/2022
Actual
Sample size
Target
752
Accrual to date
Final
1341
Recruitment outside Australia
Country [1] 23360 0
New Zealand
State/province [1] 23360 0
Auckland

Funding & Sponsors
Funding source category [1] 307525 0
Charities/Societies/Foundations
Name [1] 307525 0
The Royal Australian and New Zealand College of Obstetrician and Gynaecologists c/o The Mercia Barnes Trust
Country [1] 307525 0
New Zealand
Primary sponsor type
Government body
Name
Department of Women's Health, Auckland District Health Board
Address
2 Park Road, Grafton, Auckland 1023
Country
New Zealand
Secondary sponsor category [1] 308204 0
None
Name [1] 308204 0
Address [1] 308204 0
Country [1] 308204 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307592 0
Northern A Health and Disability Ethics Committees
Ethics committee address [1] 307592 0
Ethics committee country [1] 307592 0
New Zealand
Date submitted for ethics approval [1] 307592 0
Approval date [1] 307592 0
11/09/2019
Ethics approval number [1] 307592 0
19/NTA/117

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 107790 0
Dr Helen Winrow
Address 107790 0
Department of Obstetrics and Gynaecology
Auckland City Hospital
2 Park Road
Grafton
Auckland 1023
Country 107790 0
New Zealand
Phone 107790 0
+64 220357074
Fax 107790 0
Email 107790 0
[email protected]
Contact person for public queries
Name 107791 0
Helen Winrow
Address 107791 0
Department of Obstetrics and Gynaecology
Auckland City Hospital
2 Park Road
Grafton
Auckland 1023
Country 107791 0
New Zealand
Phone 107791 0
+64 220357074
Fax 107791 0
Email 107791 0
[email protected]
Contact person for scientific queries
Name 107792 0
Helen Winrow
Address 107792 0
Department of Obstetrics and Gynaecology
Auckland City Hospital
2 Park Road
Grafton
Auckland 1023
Country 107792 0
New Zealand
Phone 107792 0
+64 220357074
Fax 107792 0
Email 107792 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?
All individual participant data will be available after de-identification
When will data be available (start and end dates)?
Start: Immediately following publication
End: No end date
Available to whom?
Researchers on a case-by-case basis at the discretion of the research team
Available for what types of analyses?
For meta-analyses, to achieve aims set out in the primary proposal
How or where can data be obtained?
On request from Dr Michelle Wise, Senior Lecturer, Department of Obstetrics and Gynaecology, University of Auckland. Email address: [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10196Study protocol    381183-(Uploaded-07-01-2021-18-14-56)-Study-related document.docx
10197Ethical approval    381183-(Uploaded-07-01-2021-18-15-18)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo 381183-(Uploaded-14-02-2023-13-07-37)-Basic results summary.docx
Plain language summaryNo The PICS bundle did not result in a statistically ... [More Details]

Documents added automatically
No additional documents have been identified.