Reduction Of Surgical Site Infection using several Novel Interventions

• Research type

  Research Study

• Full title

  ROSSINI 2: 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, alone or in combination, to reduce SSI rates in patients undergoing abdominal surgery.

• IRAS ID

  247285

• Contact name

  Thomas Pinkney

• Contact email

  thomas.pinkney@uhb.nhs.uk

• Sponsor organisation

  University of Birmingham

• ISRCTN Number

  ISRCTN78305317

• Duration of Study in the UK

  4 years, 0 months, 1 days

• Research summary

  BACKGROUND:
  Surgical site infection (SSI) is a significant problem for patients and the health service, but is potentially preventable. Up to 25% of patients undergoing abdominal operations will develop an SSI. At an average cost of £3500 per SSI, it has been estimated that SSIs currently cost the NHS around £700 million per year, largely through prolonged postoperative inpatient stay and additional inpatient and outpatient treatment costs. Patients who develop SSIs have higher rates of pain and discomfort, with an increased risk of death following their operation.

  AIM:
  The aim of ROSSINI 2 is to see whether three new in-theatre interventions, alone or in combination, reduce the rate of SSI.

  METHODS:
  This multicentre, multi-arm, multi-stage, randomised clinical trial, will assess three separate in-theatre interventions used alone or in combination. The interventions include a skin preparation solution (2% alcoholic chlorhexadine skin prep) that is applied to the skin before starting surgery, a skin drape (Iodophor-impregnated incise drape) -a thin impregnated plastic sheet applied to the skin before making the incision and a sponge (gentamicin impregnated implant), which is an implant that contains antibiotics that is placed into the wound before closure. We will recruit 6613 patients from around 68 hospitals across the UK to go into the trial. The primary outcome measure is the rate of SSI at 30 days post-surgery. Numerous secondary outcomes will also be collected, including cost effectiveness of the interventions and impact on participants quality of life.
  Our findings will be published in international medical journals so that they can help patients globally.

• REC name

  Wales REC 6

• REC reference

  19/WA/0019

• Date of REC Opinion

  29 Jan 2019

• REC opinion

  Further Information Favourable Opinion