- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03838575
ROSSINI 2 - Reduction of Surgical Site Infection Using Several Novel Interventions (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 Several In-theatre Interventions, Used Alone or in Combination, to Reduce SSI Rates in Patients Undergoing Abdominal Surgery.
Study Overview
Status
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:
- 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
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Kayley King
- Phone Number: 00 44 121 415 8840
- Email: k.king.2@bham.ac.uk
Study Contact Backup
- Name: ROSSINI 2 Mailbox
- Email: rossini2@trials.bham.ac.uk
Study Locations
-
-
-
Birmingham, United Kingdom, B15 2GW
- Recruiting
- Queen Elizabeth Hospital Birmingham
-
Contact:
- Professor Pinkney
-
Chester, United Kingdom, CH2 1UL
- Recruiting
- Countess of Chester Hospital
-
Contact:
- Mr Vimalachandran
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: A - NONE (Control)
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. |
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. |
Active Comparator: B - SKIN PREP
Mechanism: A broad-spectrum antiseptic to clean and prepare the skin prior to surgery. Supplier: BD |
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).
Other Names:
|
Other: C - DRAPE
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 |
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.
Other Names:
|
Active Comparator: D - SPONGE
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 |
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.
Other Names:
|
Other: E - SKIN PREP and DRAPE
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) |
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).
Other Names:
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.
Other Names:
|
Active Comparator: F - SKIN PREP and SPONGE
See descriptions in single arms (B & D)
|
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).
Other Names:
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.
Other Names:
|
Other: G - DRAPE and SPONGE
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) |
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.
Other Names:
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.
Other Names:
|
Other: H - SKIN PREP and DRAPE and SPONGE
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) |
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).
Other Names:
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.
Other Names:
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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.
Time Frame: 30 days post surgery
|
The CDC definition will be used in ROSSINI 2 to identify deep incisional or superficial incisional SSIs.
|
30 days post surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
30-day postoperative mortality rate (POMR).
Time Frame: Within 30 days post surgery
|
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.
Time Frame: Within 30 days post surgery
|
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).
Time Frame: Within 30 days post surgery
|
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.
Time Frame: Measured from the date of surgery (Day 0) to the date of discharge (expected to be within 30 days.)
|
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.
Time Frame: Within 30 days post surgery
|
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.
Time Frame: Within 30 days post surgery
|
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
Time Frame: Baseline, Day 7, Day 30 and if applicable Ongoing SSI (Day 60, 90, 120 etc)
|
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
Time Frame: To complete at Day 30 and if applicable Ongoing SSI (Day 60, 90, 120 etc)
|
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)
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Wounds and Injuries
- Disease Attributes
- Infections
- Communicable Diseases
- Surgical Wound
- Surgical Wound Infection
- Wound Infection
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents, Local
- Enzyme Inhibitors
- Protein Synthesis Inhibitors
- Disinfectants
- Anti-Bacterial Agents
- Gentamicins
- Chlorhexidine
- Anti-Infective Agents
Other Study ID Numbers
- RG_18-186
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Surgery
-
3MRecruitingAbdominal Surgery | Orthopedic Surgery | Vascular Surgery | Cardiovascular SurgeryUnited States
-
Vanderbilt UniversityCompletedHand Surgery | Wrist Surgery | Forearm Surgery | Elbow SurgeryUnited States
-
Nantes University HospitalCompletedGynecological Surgery | Plastic Surgery | ENT SurgeryFrance
-
Edwards LifesciencesCompletedAbdominal Surgery | Pelvic Surgery | Non-Cardiac/ Non-Thoracic Surgery | Major Peripheral Vascular SurgeryUnited States
-
Maquet Cardiopulmonary GmbHNAMSARecruitingCardiac Surgery | Cardiopulmonary Bypass | Thoracic Surgery | Vascular SurgerySpain
-
Baylor Research InstituteChiesi USA, Inc.RecruitingSurgery | Cardiac Surgery | Surgery--Complications | Percutaneous Coronary InterventionUnited States
-
Vanderbilt UniversityEdwards LifesciencesCompletedCardiac Surgery | Thoracic Surgery | Heart Surgery | Heart Transplant
-
Surgify Medical OyCompletedSurgery | Spine SurgeryFinland
-
Cairo UniversityBatterjee Medical College; Taif UniversityCompletedSurgery | Bariatric SurgeryEgypt, Saudi Arabia
-
Poudre Valley Health SystemTerminatedSurgery | Surgery--ComplicationsUnited States
Clinical Trials on NONE (Control)
-
Khyber Medical College, PeshawarNot yet recruiting
-
University of SurreyCompletedAutism Spectrum DisorderUnited Kingdom
-
University of Illinois at Urbana-ChampaignCompletedObesity | Weight, BodyUnited States
-
Academisch Medisch Centrum - Universiteit van Amsterdam...RecruitingCoagulation Disorder | Endocarditis | Valve Disease, HeartNetherlands
-
University of OxfordRecruiting
-
University of Campania "Luigi Vanvitelli"CompletedBirth Weight | Systemic Inflammation Markers | Combined Systemic Inflammatory IndicesItaly
-
University of AarhusCompletedDiabetes Mellitus, Type 2 | Bone FragileDenmark
-
Eunice Kennedy Shriver National Institute of Child...New York State Department of Health; University at AlbanyCompletedObesity | Asthma | Blood Pressure | Developmental Delay | Allergies | Motor Delay
-
Austin HealthCompletedReflux, Gastroesophageal | Colon Disease | Colon Polyp | Varices, EsophagealAustralia
-
University of GiessenCompleted