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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

6610 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2023-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Surgical Site Infection Surgical Wound Infection Surgery--Complications Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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.

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

NONE (Control)

Intervention Type 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.

B - SKIN PREP

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

Supplier: BD

Group Type ACTIVE_COMPARATOR

2% alcoholic chlorhexidine skin prep (SKIN PREP)

Intervention Type 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).

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

Group Type OTHER

Iodophor Antimicrobial Incise Drapes (DRAPE)

Intervention Type 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.

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

Group Type ACTIVE_COMPARATOR

Gentamicin-impregnated implants/ sponges (SPONGE)

Intervention Type 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.

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)

Group Type OTHER

2% alcoholic chlorhexidine skin prep (SKIN PREP)

Intervention Type 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).

Iodophor Antimicrobial Incise Drapes (DRAPE)

Intervention Type 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.

F - SKIN PREP and SPONGE

See descriptions in single arms (B \& D)

Group Type ACTIVE_COMPARATOR

2% alcoholic chlorhexidine skin prep (SKIN PREP)

Intervention Type 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).

Gentamicin-impregnated implants/ sponges (SPONGE)

Intervention Type 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.

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)

Group Type OTHER

Iodophor Antimicrobial Incise Drapes (DRAPE)

Intervention Type 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.

Gentamicin-impregnated implants/ sponges (SPONGE)

Intervention Type 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.

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)

Group Type OTHER

2% alcoholic chlorhexidine skin prep (SKIN PREP)

Intervention Type 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).

Iodophor Antimicrobial Incise Drapes (DRAPE)

Intervention Type 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.

Gentamicin-impregnated implants/ sponges (SPONGE)

Intervention Type 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.

Interventions

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2% alcoholic chlorhexidine skin prep (SKIN PREP)

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).

Intervention Type DRUG

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.

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.

Intervention Type DEVICE

Gentamicin-impregnated implants/ sponges (SPONGE)

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.

Intervention Type DEVICE

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.

Intervention Type OTHER

Other Intervention Names

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Chloraprep Ioban Incise Drape Collatamp G

Eligibility Criteria

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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.

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No