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The PICS Project -Prevention of Infection after Caesarean Section

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.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621000343808
Acronym
PICS
Enrollment
1341
Registered
2021-03-25
Start date
2021-05-03
Completion date
2021-11-28
Last updated
2022-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The study aims to determine whether the introduction of a peri-operative bundle of care could reduce the rate of post-caesarean section surgical site infection and complications. This includes genital-tract sepsis, endometritis, wound infection, haematoma and seroma. We hypothesise that the implementation of an evidence-based peri-operative bundle will reduce the absolute rate of post-caesarean surgical site infection and wound complications.

Interventions

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:

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.

Sponsors

Department of Women's Health, Auckland District Health Board
Lead SponsorGovernment body

Study design

Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
15 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patients having a Caesarean section at Auckland City Hospital

Exclusion criteria

None

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026