ROSSINI 2 - Reduction of Surgical Site Infection Using Several Novel Interventions

NCT03838575 | Unknown Phase 3 DMC

• 1 other identifier: RG_18-186
• Study Type: interventional
• Target: 6,610
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• 30-day postoperative mortality rate (POMR).

  Within 30 days post surgery

• 30-day postoperative wound complication rate.

  Within 30 days post surgery

• Serious Adverse Events up to 30 days (wounds or intervention-related only).

  Within 30 days post surgery

• Length of hospital stay after surgery as measured from the date of surgery to the date of discharge.

  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.

  Within 30 days post surgery

Study Arms (8)

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.

Other: NONE (Control)

B - SKIN PREP

ACTIVE COMPARATOR

Mechanism: A broad-spectrum antiseptic to clean and prepare the skin prior to surgery. Supplier: BD

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

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

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)

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)

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)

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)

Drug: 2% alcoholic chlorhexidine skin prep (SKIN PREP); Device: Iodophor Antimicrobial Incise Drapes (DRAPE); Device: Gentamicin-impregnated implants/ sponges (SPONGE)

Interventions

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).

Also known as: Chloraprep

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) 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.

Also known as: Ioban Incise Drape

C - DRAPE; E - SKIN PREP and DRAPE; G - DRAPE and SPONGE; H - SKIN PREP and DRAPE and SPONGE

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.

Also known as: Collatamp G

D - SPONGE; F - SKIN PREP and SPONGE; G - DRAPE and SPONGE; H - SKIN PREP and DRAPE and SPONGE

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.

A - NONE (Control)

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Birmingham: lead
• National Institute for Health Research, United Kingdom: collaborator
• University College, London: collaborator

Study Sites (2)

Queen Elizabeth Hospital Birmingham

Birmingham, B15 2GW, United Kingdom

RECRUITING

Countess of Chester Hospital

Chester, CH2 1UL, United Kingdom

RECRUITING

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Kayley King

CONTACT

00 44 121 415 8840; k.king.2@bham.ac.uk

ROSSINI 2 Mailbox

CONTACT

rossini2@trials.bham.ac.uk

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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): * Randomisation in theatre after induction of anaesthesia * The intraoperative interventions used will not be documented in the operation notes or in the patient's notes. * The skin around the closed wound will be wiped clean using a wet sterile towel at the end of the procedure to prevent unblinding. * Clinical follow-up will be conducted by a trained surgeon or a trained member of the local research team who did not participate in the index procedure or surgery.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 5, 2019
• First Posted: February 12, 2019
• Study Start: March 1, 2019
• Primary Completion: May 1, 2023
• Study Completion: August 1, 2023
• Last Updated: November 28, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)