Overview

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.