Prevention of surgical site infection in 6 surgical specialities: obstetrics: caesarean section
Conditions
Interventions
Individual pillars have prioritised three specific peri-operative interventions for initial testing based on: (1) evidence of potential clinical effectiveness, (2) patient acceptability and (3) clinic
Sponsors
Birmingham Clinical Trials Unit
Eligibility
Sex/Gender
All
Age
12 Years to 120 Years
Inclusion criteria
Inclusion criteria: As there are 6 surgical specialities, there are platform level and pillar-specific level eligibility criteria. The platform level criteria are listed below. 1. Patients undergoing vascular groin, LLA, breast, cardiac, obstetric, vascular groin or neurosurgery at a ROSSINI-Platform participating hospital. 2. Patients (or via support from family member/ carer etc) with an email address and/or telephone number who are able and willing to provide follow-up through the CDWH 3. Able to give informed consent, with interpreters where necessary OR consultee/representative provides assent/consent if a patient temporarily lacks capacity The pillar-specific eligibility are within each pillar specific protocol.
Exclusion criteria
Exclusion criteria: Platform level exclusion criteria: 1. Previous participation in any Pillar of ROSSINI-Platform within the last 90 days. There are pillar-specific exclusion criteria listed within each protocol (not enough space to detail them all here).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is SSI within 30 days of surgery, as defined according to a modified 2017 Centers for Disease Control (CDC) and Prevention criteria. Whilst several systems exist to define SSI, the internationally recognised CDC definitions are the current gold standard for SSI assessment and have been used in a number of multicentre randomised trials. The following CDC definition will be used in ROSSINI-Platform to identify deep incisional or superficial incisional SSIs: 1. The infection must occur within 30-days of the index operation AND 2. The infection must involve the skin, subcutaneous, muscular or fascial layers of the incision AND 3. The patient must have at least one of the following: • Purulent drainage from the incision OR • Wound opened spontaneously or deliberately by a clinician AND the patient has at least one of: pain or tenderness; localised swelling; erythema or heat; fever (>38°C). OR • Organisms are cultured from a culture taken from the wound using an aseptic technique OR • Diagnosis of SSI by a clinician or on imaging Surgical site infection in ROSSINI-Platform encompasses both superficial and deep incisional wound infections. In practice, a deep incisional infection will manifest alongside a superficial one and can be viewed as a more severe subset of the latter. We will not seek to differentiate between deep and superficial SSI as our interventions seek to prevent both. The primary outcome is measured at 30 days post surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| 30-day and 90-day postoperative mortality rate (POMR). 30-day postoperative worst wound complication (Clavien-Dindo classification for vascular groin, LLA, breast, cardiac and obstetrics; Landriel-Ibanez33 classification for neurosurgery). Risk of wound or intervention only related Serious Adverse Events up to 30 and 90 days post-surgery. Length of hospital stay after surgery as measured from the date of surgery to the date fit for discharge from primary site collected via hospital records. Risk of hospital re-admission for wound related complications within 30 and 90 days post-surgery. Risk of wound reopening and/or re-operations within 30 and 90 days post-surgery. Preference-based Quality of Life (QoL EQ-5D-5L) collected at Baseline, Day of Discharge and weekly until Day 30 post-surgery via the CDWH. Cost effectiveness (Resource Use Questionnaire; RUQ). • 30-day and 90-day postoperative mortality rate (POMR). • 30-day postoperative worst wound complication rate • Wound or intervention only related Serious Adverse Events up to 30 and 90 days post-operatively. • Length of hospital stay after surgery as measured from the date of surgery to the date fit for discharge from primary site collected via hospital records. • Hospital re-admission for wound related complications within 30 and 90 days post-discharge. • Risk ogf wound reopening and/or re-operations within 30 and 90 days post operation. • Preference-based Quality of Life (QoL EQ-5D-5L) collected at Baseline, Day of Discharge and weekly | — |
Countries
England, United Kingdom
Contacts
Public Contact- ROSSINI- Platform Trial Team
Outcome results
None listed