ROSSINI 2  

Status: Open

Specialty: Colorectal

Date Opened: 30/03/2022

Planned Close Date: 30/10/2026

Sponsor: NIHR CRN: West Midlands  

Principal Investigator: Mr Edward Parkin

Study Title: ROSSINI 2: A Phase III, multi-arm, multi-stage (MAMS) pragmatic, blinded (patient and outcome assessor) multicentre, randomised controlled trial (RCT) with an internal pilot, to evaluate the use of three in-theatre interventions, alone or in combination, to reduce SSI rates in patients undergoing abdominal surgery. 

BACKGROUND:

Surgical site infection (SSI) is a significant problem for patients and the health service, but is potentially preventable. Up to 25% of patients undergoing abdominal operations will develop an SSI. At an average cost of £3500 per SSI, it has been estimated that SSIs currently cost the NHS around £700 million per year, largely through prolonged postoperative inpatient stay and additional inpatient and outpatient treatment costs. Patients who develop SSIs have higher rates of pain and discomfort, with an increased risk of death following their operation.

AIM:

The aim of ROSSINI 2 is to see whether three new in-theatre interventions, alone or in combination, reduce the rate of SSI.

METHODS:

This multicentre, multi-arm, multi-stage, randomised clinical trial, will assess three separate in-theatre interventions used alone or in combination. The interventions include a skin preparation solution (2% alcoholic chlorhexadine skin prep) that is applied to the skin before starting surgery, a skin drape (Iodophor-impregnated incise drape) -a thin impregnated plastic sheet applied to the skin before making the incision and a sponge (gentamicin impregnated implant), which is an implant that contains antibiotics that is placed into the wound before closure. We will recruit 6613 patients from around 68 hospitals across the UK to go into the trial. The primary outcome measure is the rate of SSI at 30 days post-surgery. Numerous secondary outcomes will also be collected, including cost effectiveness of the interventions and impact on participants quality of life.

Our findings will be published in international medical journals so that they can help patients globally.