The ROSSINI-Platform Trial: A basket factorial multi-arm multi-stage (MAMS) platform randomised controlled trial (RCT) to evaluate the use of multiple interventions to reduce surgical site infection SSI across several types of surgery

Registry ID
ISRCTN95680782
Source registry
ISRCTN
Status
Recruiting
Phase
PHASE3
Study type
INTERVENTIONAL
Sponsor
Birmingham Clinical Trials Unit
Enrollment
25924
Start date
2026-05-31
Completion date
2029-12-31
Last update
2026-08-17

Conditions

Summary

Prevention of surgical site infection in 6 surgical specialities: obstetrics: caesarean section; neurosurgery; vascular groin; vascular amputation; cardiac; breast

Detailed description

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) clinician equipoise within their clinical area. Each individual intervention will be compared against those participants not allocated to receive the intervention. See below a list of interventions used in each pillar Neurosurgery Pillar: Intervention 1: Topical Vancomycin powder under scalp flap Once the muscle and/or galea has been closed but prior to skin closure, the vancomycin powder (500mg) will be placed topically on the wound edges for the intervention arm. It will be spread out evenly across the length of the wound and a swab may be used to pat it down into the wound. The skin will then be closed in the standard fashion. In the standard care arm no powder will be used and the skin will be closed in the standard fashion. Neurosurgery Pillar Intervention 2: Bone flap stored in betadine. Once the craniotomy has been performed and the bone flap lifted off, it will be put into a bowl/dish and submerged in either saline or aqueous betadine (as per randomisation allocation). It will remain in this fluid for the rest of the operation until the surgeon is ready to re-implant the bone flap at which point it will be removed to enable securing of screws/mini-plates and placed back into the participant. Neurosurgery Pillar: Intervention 3: Wound irrigation prior to closure Once the bone flap has been replaced and secured and the surgeon is ready to start closing the muscle/superficial layers, then a large volume wash of a minimum of 1L of warm saline will be used to irrigate the wound. In the standard practice arm, the surgeon can choose to wash the wound at this stage with as much or as little saline as per their standard practice and this does not need to be measured. Cardiac Pillar: Intervention 1: Glove and Instrument change prior to wound closure The surgical team (surgeons,

Interventions

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

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).

Locations

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