Status:
UNKNOWN
ROSSINI 2 - Reduction of Surgical Site Infection Using Several Novel Interventions
Lead Sponsor:
University of Birmingham
Collaborating Sponsors:
National Institute for Health Research, United Kingdom
University College, London
Conditions:
Surgical Site Infection
Surgical Wound Infection
Eligibility:
All Genders
16+ years
Phase:
PHASE3
Brief Summary
ROSSINI 2 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...
Detailed Description
The primary objective of ROSSINI 2 is to determine whether several specific in-theatre interventions, used alone or in combination, result in decreased rates of surgical site infection (SSI) up to 30 ...
Eligibility Criteria
Inclusion
- 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 undergo a wound assessment at day 30-37 after surgery
- 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
- Previous laparotomy within 3 months prior to randomisation
- Known to be pregnant or currently breast feeding
- Operations where the wound is not anticipated to be closed primarily
- 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.
Key Trial Info
Start Date :
March 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2023
Estimated Enrollment :
6610 Patients enrolled
Trial Details
Trial ID
NCT03838575
Start Date
March 1 2019
End Date
August 1 2023
Last Update
November 28 2022
Active Locations (2)
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1
Queen Elizabeth Hospital Birmingham
Birmingham, United Kingdom, B15 2GW
2
Countess of Chester Hospital
Chester, United Kingdom, CH2 1UL