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

• Status: Recruiting
• Trial end date: 2022-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This 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 three in-theatre interventions to reduce SSI rates in patients undergoing surgery with an abdominal incision. ROSSINI 2 is a non-factorial superiority design with allocation of various combinations of the three interventions to be used during the same operation, via seven possible treatment arms plus one control arm initially.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Birmingham
• Collaborators: National Institute for Health Research, United Kingdom; University College, London
• Treatments: Anti-Bacterial Agents; Anti-Infective Agents; Chlorhexidine; Chlorhexidine gluconate; Gentamicins

Criteria

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.

Exclusion Criteria:

• 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.