ROSSINI 2 - Reduction of Surgical Site Infection Using Several Novel Interventions
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Surgery
- Surgery- Complications
- Surgical Site Infection
- Surgical Wound Infection
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: This major, multicentre, multi-arm, multi-stage (MAMS) trial with the opportunity to cease (and introduce) arms would be the first of its kind in a surgical setting. In addition to generating new knowledge in our primary research area, by utilising this advanced design in the context of our relatively simple primary endpoint of SSI, it will also pave the way for future efficient and rapid trials in other aspects of surgical care.Masking: Double (Participant, Outcomes Assessor)Masking Description: ROSSINI 2 is a double blind trial; both the patient and outcome assessor will be blinded to the intraoperative intervention(s). It is not possible to blind the operating surgeon to the intervention allocation. The following measures will be taken to ensure concealment of the chosen intervention(s) (blinding): Randomisation in theatre after induction of anaesthesia The intraoperative interventions used will not be documented in the operation notes or in the patient's notes. The skin around the closed wound will be wiped clean using a wet sterile towel at the end of the procedure to prevent unblinding. Clinical follow-up will be conducted by a trained surgeon or a trained member of the local research team who did not participate in the index procedure or surgery. Primary Purpose: Prevention
Participation Requirements
- Age
- Between 16 years and 125 years
- Gender
- Both males and females
Description
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 participat...
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): 2% alcoholic chlorhexidine skin preparation, versus any other standard skin preparation Iodophor-impregnated incise drape, versus no drape Gentamicin-impregnated implants/ sponge at closure, versus no implant
Tracking Information
- NCT #
- NCT03838575
- Collaborators
- National Institute for Health Research, United Kingdom
- University College, London
- Investigators
- Not Provided
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