Clinical trial NCT03838575: ROSSINI 2 - Reduction of Surgical Site Infection Using Several Novel Interventions
Official title: 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 Several In-theatre Interventions, Used Alone or in Combination, to Reduce SSI Rates in Patients Undergoing Abdominal Surgery.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Surgical Site Infection
Surgical Wound Infection
Surgery--Complications
Surgery
Keywords: SSI
Surgical Site Infection
Infection Prevention
MAMS
Multi-arm, Multi-stage
Pragmatic
Abdominal Surgery
Multicentre
RCT
Pilot
Chlorhexidine
Skin Prep
Iodophor
Drape
Gentamicin
Sponge
Surgery
Lead sponsor: University of Birmingham
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
name: University College, London
First posted: 2019-02-12
Enrollment: 6610
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.

Please note: In January 2022, following the first interim analysis, arms including intervention 2 - Iodophor-impregnated incise drape (arms C, E, G and H) were closed to recruitment. This means that only 3 interventional arms (4 including the control arm) remain in the trial.
Primary purpose: PREVENTION

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 several in-theatre interventions, used alone or in combination, to reduce SSI rates in patients undergoing surgery.

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 days post operation in adult patients undergoing abdominal surgery.

At least 60 NHS hospitals in the UK will participate in ROSSINI 2.

Approximately 6610 patients will be required to detect a 5% absolute risk reduction in the intervention arm(s) (15% to 10%; 33% relative reduction) with 85% power.

Initially, the three health technologies that were assessed versus the control arm (standard care) were:

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

Please note: In January 2022, following the first interim analysis, arms including intervention 2 - Iodophor-impregnated incise drape (arms C, E, G and H) were closed to recruitment.

Eligibility 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 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 Criteria:

* 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.

Primary outcomes:
measure: SSI rate up to 30 days after surgery as defined according to the 2017 Centers for Disease Control (CDC) and Prevention Criteria.
timeFrame: 30 days post surgery
Secondary outcomes:
measure: 30-day postoperative mortality rate (POMR).
timeFrame: Within 30 days post surgery
measure: 30-day postoperative wound complication rate.
timeFrame: Within 30 days post surgery
measure: Serious Adverse Events up to 30 days (wounds or intervention-related only).
timeFrame: Within 30 days post surgery
measure: Length of hospital stay after surgery as measured from the date of surgery to the date of discharge.
timeFrame: Measured from the date of surgery (Day 0) to the date of discharge (expected to be within 30 days.)
measure: Hospital re-admission for wound related complications within 30 days.
timeFrame: Within 30 days post surgery
measure: Occurrence of unplanned wound reopening and/or re-operations within 30 days post-operation.
timeFrame: Within 30 days post surgery
measure: Health-related, preference-based quality of life
timeFrame: Baseline, Day 7, Day 30 and if applicable Ongoing SSI (Day 60, 90, 120 etc)
measure: Cost-effectiveness
timeFrame: To complete at Day 30 and if applicable Ongoing SSI (Day 60, 90, 120 etc)
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital Birmingham
city: Chester
country: United Kingdom
facility: Countess of Chester Hospital
Study officials:
References: