ROSSINI 2 - Reduction of Surgical Site Infection Using Several Novel Interventions — ROSSINI 2  

Surgery Clinical Trial

Official title: 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 Several In-theatre Interventions, Used Alone or in Combination, to Reduce SSI Rates in Patients Undergoing Abdominal Surgery.

Status Recruiting

Clinical Trial Summary

ROSSINI 2 is 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 several in-theatre interventions, used alone or in combination, to reduce SSI rates in patients undergoing surgery.

Clinical Trial Description

The primary objective of ROSSINI 2 is to determine whether several specific in-theatre interventions, used alone or in combination, result in decreased rates of surgical site infection (SSI) up to 30 days post operation in adult patients undergoing abdominal surgery.

At least 60 NHS hospitals in the UK will participate in ROSSINI 2.

Approximately 6610 patients will be required to detect a 5% absolute risk reduction in the intervention arm(s) (15% to 10%; 33% relative reduction) with 85% power.

Initially, the three health technologies that were assessed versus the control arm (standard care) were:

1. 2% alcoholic chlorhexidine skin preparation, versus any other standard skin preparation

2. Iodophor-impregnated incise drape, versus no drape

3. Gentamicin-impregnated implants/ sponge at closure, versus no implant

Please note: In January 2022, following the first interim analysis, arms including intervention 2 - Iodophor-impregnated incise drape (arms C, E, G and H) were closed to recruitment. ;

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Surgery
• Surgery--Complications
• Surgical Site Infection
• Surgical Wound
• Surgical Wound Infection
• Wound Infection

• NCT number: NCT03838575
• Study type: Interventional
• Source: University of Birmingham
• Contact: Kayley King
• Phone: 00 44 121 415 8840
• Email: k.king.2@bham.ac.uk
• Status: Recruiting
• Phase: Phase 3
• Start date: March 1, 2019
• Completion date: August 2023