Surgical Site InfectionPhase 3ROSSINI 2NCT03838575
ROSSINI 2 - Reduction of Surgical Site Infection Using Several Novel Interventions
A Phase 3 study testing 2% alcoholic chlorhexidine skin prep (SKIN PREP), Iodophor Antimicrobial Incise Drapes (DRAPE) and Gentamicin-impregnated implants/ sponges (SPONGE) in people with Surgical Site Infection and Surgical Wound Infection, run by University of Birmingham at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Surgical Site Infection, Surgical Wound Infection, Surgery--Complications
- What is being tested?
- 2% alcoholic chlorhexidine skin prep (SKIN PREP), Iodophor Antimicrobial Incise Drapes (DRAPE) and Gentamicin-impregnated implants/ sponges (SPONGE)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,610 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 1 Mar 2019to Aug 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
ROSSINI 2 Mailbox contact
United Kingdom2 sites, 2 recruiting
- Recruiting
Queen Elizabeth Hospital Birmingham
Birmingham, B15 2GW
Professor Pinkney
- Recruiting
Countess of Chester Hospital
Chester, CH2 1UL
Mr Vimalachandran
About this study
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.
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.
Read the 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.
- Being tested
- 2% alcoholic chlorhexidine skin prep (SKIN PREP), Iodophor Antimicrobial Incise Drapes (DRAPE), Gentamicin-impregnated implants/ sponges (SPONGE), NONE (Control)
- 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
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2% alcoholic chlorhexidine skin prep (SKIN PREP)Drug
Also called Chloraprep
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).
Iodophor Antimicrobial Incise Drapes (DRAPE)Device
Also called Ioban Incise 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.
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.
Gentamicin-impregnated implants/ sponges (SPONGE)Device
Also called Collatamp G
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: NONE (Control) |
| B - SKIN PREP | Active comparator | Mechanism: A broad-spectrum antiseptic to clean and prepare the skin prior to surgery.
Supplier: BD Receives: Drug: 2% alcoholic chlorhexidine skin prep (SKIN PREP) |
| 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 Receives: Device: Iodophor Antimicrobial Incise Drapes (DRAPE) |
| 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 Receives: Device: Gentamicin-impregnated implants/ sponges (SPONGE) |
| E - SKIN PREP and 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.
See descriptions in single arms (B \& C) Receives: Drug: 2% alcoholic chlorhexidine skin prep (SKIN PREP); Device: Iodophor Antimicrobial Incise Drapes (DRAPE) |
| F - SKIN PREP and SPONGE | Active comparator | See descriptions in single arms (B \& D) Receives: Drug: 2% alcoholic chlorhexidine skin prep (SKIN PREP); Device: Gentamicin-impregnated implants/ sponges (SPONGE) |
| 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) Receives: Device: Iodophor Antimicrobial Incise Drapes (DRAPE); Device: Gentamicin-impregnated implants/ sponges (SPONGE) |
| 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) Receives: Drug: 2% alcoholic chlorhexidine skin prep (SKIN PREP); Device: Iodophor Antimicrobial Incise Drapes (DRAPE); Device: Gentamicin-impregnated implants/ sponges (SPONGE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days post surgery
Secondary outcomes (8)
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.
Measured: Within 30 days post surgery
30-day postoperative wound complication rate.
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.
Measured: 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:
- Death (related to the trial/ intervention(s))
- Skin reactions
- Allergic reactions
- Combustion
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:
- 'Related' that is, it resulted from the administration of any of the research procedures, and
- 'Unexpected' that is, the type of event is not listed in the protocol as an expected occurrence.
Measured: 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: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: To complete at Day 30 and if applicable Ongoing SSI (Day 60, 90, 120 etc)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2019
- Study start1 Mar 2019
- Primary completionMay 2023 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 6,610 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, University College, London
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03838575
- Sponsor's protocol ID
- RG_18-186
- Acronym
- ROSSINI 2
- Status last verified
- Jun 2022
- First submitted
- 5 Feb 2019
- Last updated
- 28 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03838575
- Acronym / sponsor ID
- ROSSINI 2 / RG_18-186
- Keywords
- SSI, Surgical Site Infection, Infection Prevention, MAMS, Multi-arm, Multi-stage, Pragmatic, Abdominal Surgery, Multicentre
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6,610 participants (estimated)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, University College, London
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 12 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 8
- 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.
| Arm | Type | Receives |
|---|---|---|
| A - NONE (Control) | Active comparator | Other: 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. |
| B - SKIN PREP | Active comparator | Drug: 2% alcoholic chlorhexidine skin prep (SKIN PREP)Mechanism: A broad-spectrum antiseptic to clean and prepare the skin prior to surgery. Supplier: BD |
| C - DRAPE | Other | Device: Iodophor Antimicrobial Incise Drapes (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 |
| D - SPONGE | Active comparator | Device: Gentamicin-impregnated implants/ sponges (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 |
| E - SKIN PREP and DRAPE | Other | Drug: 2% alcoholic chlorhexidine skin prep (SKIN PREP), Device: Iodophor Antimicrobial Incise Drapes (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) |
| F - SKIN PREP and SPONGE | Active comparator | Drug: 2% alcoholic chlorhexidine skin prep (SKIN PREP), Device: Gentamicin-impregnated implants/ sponges (SPONGE)See descriptions in single arms (B \& D) |
| G - DRAPE and SPONGE | Other | Device: Iodophor Antimicrobial Incise Drapes (DRAPE), Device: Gentamicin-impregnated implants/ sponges (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) |
| H - SKIN PREP and DRAPE and SPONGE | Other | Drug: 2% alcoholic chlorhexidine skin prep (SKIN PREP), Device: Iodophor Antimicrobial Incise Drapes (DRAPE), Device: Gentamicin-impregnated implants/ sponges (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) |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2% alcoholic chlorhexidine skin prep (SKIN PREP)Also: ChloraprepThis 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). | Drug | B - SKIN PREP, E - SKIN PREP and DRAPE, F - SKIN PREP and SPONGE, H - SKIN PREP and DRAPE and SPONGE |
| Iodophor Antimicrobial Incise Drapes (DRAPE)Also: Ioban Incise DrapePlease 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. | Device | C - DRAPE, E - SKIN PREP and DRAPE, G - DRAPE and SPONGE, H - SKIN PREP and DRAPE and SPONGE |
| Gentamicin-impregnated implants/ sponges (SPONGE)Also: Collatamp GThis 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. | Device | D - SPONGE, F - SKIN PREP and SPONGE, G - DRAPE and SPONGE, H - SKIN PREP and DRAPE and SPONGE |
| 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. | Other | A - NONE (Control) |
Primary outcome
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.
8 secondary outcomes
30-day postoperative mortality rate (POMR).
Time frame: Within 30 days post surgery
30-day postoperative wound complication rate.
Time frame: Within 30 days post surgery
Serious Adverse Events up to 30 days (wounds or intervention-related only).
Time frame: 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.)
Hospital re-admission for wound related complications within 30 days.
Time frame: 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
Health-related, preference-based quality of life
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2022.
- Individual participant dataSharing planned: No. No IPD will be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ROSSINI 2 Mailbox contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 2% alcoholic chlorhexidine skin prep (SKIN PREP), Iodophor Antimicrobial Incise Drapes (DRAPE) and Gentamicin-impregnated implants/ sponges (SPONGE) in people with Surgical Site Infection and Surgical Wound Infection, run by University of Birmingham at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kayley King (00 44 121 415 8840, k.king.2@bham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2022.