ROSSINI 2 - Reduction of Surgical Site Infection Using Several Novel Interventions
ROSSINI 2 - Reduction of Surgical Site Infection Using Several Novel Interventions
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.
The primary objective of ROSSINI 2 is to determine whether three specific in-theatre
 interventions, 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.

 Ten local NHS hospitals will participate in the pilot phase of ROSSINI 2 and at least 60 NHS
 hospitals in the UK will participate in the main phase of ROSSINI 2.

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

 Three health technologies will be assessed versus their control arms (standard care):

 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
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.