NCT03838575

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

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: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 6,610 (estimated)
• Sponsor: University of Birmingham · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Surgical Site Infection
• Surgical Wound Infection
• Surgery--Complications
• Surgery

Interventions

Type	Name	Description
DRUG	2% alcoholic chlorhexidine skin prep (SKIN PREP)	This intervention describes the preparation of the intact skin incision site immediately prior to incision, using chlorhexidine gluconate (CHG) in an alcohol-based solution, providing durable sterilisation of the surgical field. Pre-prepared applicators will be available for use in this trial (ChloraPrep™ sticks, 2% CHG with 70% isopropyl alcohol, BD Infection Prevention).
DEVICE	Iodophor Antimicrobial Incise Drapes (DRAPE)	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. This intervention describes the application of a single Iodophor Antimicrobial Incise Drape to be applied topically onto the prepared and draped surgical field by sterile, gloved members of the surgical team before the surgical incision is performed. Only after the skin preparation solution has dried completely can the incise drape be applied.
DEVICE	Gentamicin-impregnated implants/ sponges (SPONGE)	This intervention describes the implantation of Gentamicin-impregnated collagen implants at the time of fascial closure. Each sponge (10 by 10 cm) contains 280mg of collagen and 130mg of gentamicin. The sponges gradually degrade and the gentamicin solution permeates into surrounding tissues to create a high local antimicrobial concentration within the surgical wound.
OTHER	NONE (Control)	Any skin preparation of the surgeon's choice may be used in the control arm apart from 2.0% Alcoholic Chlorhexidine Skin Prep. No drapes or sponges of any kind may be used.

Timeline

• Start date: 2019-03-01
• Primary completion: 2023-05-01
• Completion: 2023-08-01
• First posted: 2019-02-12
• Last updated: 2022-11-28

Locations

2 sites across 1 country: United Kingdom