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| Name | Class |
|---|---|
| National Institute for Health Research, United Kingdom | OTHER_GOV |
| University College, London | OTHER |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A - NONE (Control) | Active Comparator | Any skin preparation of the surgeon's choice may be used in the control arm apart from 2.0% Alcoholic Chlorhexidine Skin Prep. No drapes or sponges of any kind may be used. |
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| B - SKIN PREP | Active Comparator | Mechanism: A broad-spectrum antiseptic to clean and prepare the skin prior to surgery. Supplier: BD |
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| C - DRAPE | Other | 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. Mechanism: A thin impregnated plastic sheet applied to the prepared skin prior to incision to maintain sterility. Supplier: 3M Infection Prevention |
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| D - SPONGE | Active Comparator | Mechanism: Small absorbable sponges placed into the wound at the time of closure which deliver high concentrations of antibiotic locally to kill pathogens present that may go on to cause SSI. Supplier: SERB |
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| E - SKIN PREP and DRAPE | Other |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2% alcoholic chlorhexidine skin prep (SKIN PREP) | Drug | This intervention describes the preparation of the intact skin incision site immediately prior to incision, using chlorhexidine gluconate (CHG) in an alcohol-based solution, providing durable sterilisation of the surgical field. Pre-prepared applicators will be available for use in this trial (ChloraPrep™ sticks, 2% CHG with 70% isopropyl alcohol, BD Infection Prevention). |
| Measure | Description | Time Frame |
|---|---|---|
| SSI rate up to 30 days after surgery as defined according to the 2017 Centers for Disease Control (CDC) and Prevention Criteria. | The CDC definition will be used in ROSSINI 2 to identify deep incisional or superficial incisional SSIs. | 30 days post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 30-day postoperative mortality rate (POMR). | The 30-day postoperative mortality rate (POMR) is determined as death of a patient within the first 30 postoperative days, with day of surgery taken as day 0. | Within 30 days post surgery |
| 30-day postoperative wound complication rate. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kayley King | Contact | 00 44 121 415 8840 | k.king.2@bham.ac.uk | |
| ROSSINI 2 Mailbox | Contact | rossini2@trials.bham.ac.uk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Elizabeth Hospital Birmingham | Recruiting | Birmingham | B15 2GW | United Kingdom |
No IPD will be shared with other researchers.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 12, 2022 | Nov 19, 2022 |
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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.
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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):
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.
See descriptions in single arms (B & C)
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| F - SKIN PREP and SPONGE | Active Comparator | See descriptions in single arms (B & D) |
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| G - DRAPE and SPONGE | Other | 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. See descriptions in single arms (C & D) |
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| H - SKIN PREP and DRAPE and SPONGE | Other | 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. See descriptions in single arms (B, C & D) |
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| Iodophor Antimicrobial Incise Drapes (DRAPE) | Device | 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 intervention describes the application of a single Iodophor Antimicrobial Incise Drape to be applied topically onto the prepared and draped surgical field by sterile, gloved members of the surgical team before the surgical incision is performed. Only after the skin preparation solution has dried completely can the incise drape be applied. |
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| Gentamicin-impregnated implants/ sponges (SPONGE) | Device | This intervention describes the implantation of Gentamicin-impregnated collagen implants at the time of fascial closure. Each sponge (10 by 10 cm) contains 280mg of collagen and 130mg of gentamicin. The sponges gradually degrade and the gentamicin solution permeates into surrounding tissues to create a high local antimicrobial concentration within the surgical wound. |
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| NONE (Control) | Other | Any skin preparation of the surgeon's choice may be used in the control arm apart from 2.0% Alcoholic Chlorhexidine Skin Prep. No drapes or sponges of any kind may be used. |
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The 30-day postoperative complication rate is determined as the highest level Clavien-Dindo grade complication measured in the first 30 postoperative days, with day of surgery taken as day 0. Any deviation from the normal postoperative course that has an adverse effect on the patient and is not either a treatment failure or sequel, is a complication. The Clavien-Dindo classification determines the severity of a complication based on the therapeutic consequence of that complication. |
| Within 30 days post surgery |
| Serious Adverse Events up to 30 days (wounds or intervention-related only). | The following SAEs (that are related to the use of each intervention (or the control)) should always be recorded and reported (within 24 hours) to the BCTU Trials Office as a SAE, on the In-Theatre Form and SAE Form:
As ROSSINI 2 is a non - CTIMP, BCTU will not be collecting Suspected Unexpected Serious Adverse Reactions (SUSARs). We will however be collecting Related and Unexpected SAEs. A Related and Unexpected Serious Adverse Event (RUSAE) means a SAE occurring to a research participant which in the opinion of the Chief Investigator was:
| Within 30 days post surgery |
| Length of hospital stay after surgery as measured from the date of surgery to the date of discharge. | Length of hospital stay after surgery will be a 'Time to event' outcome, this will be compared between treatment groups using standard survival analysis methods. Kaplan-Meier survival curves will be constructed for visual presentation of time-to-event comparisons. Cox proportional hazard models will be fitted to obtain adjusted treatment effects which will be expressed as hazard ratios with 95% confidence intervals. | Measured from the date of surgery (Day 0) to the date of discharge (expected to be within 30 days.) |
| Hospital re-admission for wound related complications within 30 days. | Hospital re-admissions for wound related complications within 30 days after surgery will be a 'Time to event' outcome, this will be compared between treatment groups using standard survival analysis methods. Kaplan-Meier survival curves will be constructed for visual presentation of time-to-event comparisons. Cox proportional hazard models will be fitted to obtain adjusted treatment effects which will be expressed as hazard ratios with 95% confidence intervals. | Within 30 days post surgery |
| Occurrence of unplanned wound reopening and/or re-operations within 30 days post-operation. | Occurrence of unplanned wound reopening and/or re-operations within 30 days after surgery will be a 'Time to event' outcome, this will be compared between treatment groups using standard survival analysis methods. Kaplan-Meier survival curves will be constructed for visual presentation of time-to-event comparisons. Cox proportional hazard models will be fitted to obtain adjusted treatment effects which will be expressed as hazard ratios with 95% confidence intervals. | Within 30 days post surgery |
| Health-related, preference-based quality of life | QoL will be assessed using the widely validated EuroQol EQ-5D-5L questionnaire at baseline (preoperative), as an inpatient (day 7 or at discharge if sooner) and day 30 mirroring the timings of blinded wound assessment. | Baseline, Day 7, Day 30 and if applicable Ongoing SSI (Day 60, 90, 120 etc) |
| Cost-effectiveness | Cost effectiveness will be assessed using the Resource Usage Form to collect patient-level health resource usage both in primary and secondary care; reported in QALYs. | To complete at Day 30 and if applicable Ongoing SSI (Day 60, 90, 120 etc) |
| Countess of Chester Hospital | Recruiting | Chester | CH2 1UL | United Kingdom |
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| Prot_000.pdf |
| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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