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.
Inclusion criteria
• Patients undergoing colorectal, hepatobiliary, upper GI, urological, vascular, or gynaecological operations
• Patients undergoing abdominal operations (open or laparoscopic extraction site) with a planned incision of at least 5cm.
• Patients aged 16 years or older
• Patients able and willing to give written informed consent
• All contamination strata, including clean, clean-contaminated, contaminated or dirty surgery.
• Patients undergoing planned (elective or expedited) or unplanned (emergency) surgery.
• Previous laparotomy within 3 months prior to randomisation
• Patients with a new or documented allergy/ intolerance to any of the study interventions (chlorhexidine, iodine, collagen or gentamicin) will not be randomised to an arm containing this intervention, but will still be eligible for recruitment to other arms of the study.
• Patients with end-stage renal failure where gentamicin administration would otherwise be contra-indicated (according to local policy) will not be randomised to arms containing the gentamicin-impregnated sponge.
Lead Research Nurse: Mandie Alty (x2031) amanda.alty@lthtr.nhs.uk
Link to EDGE