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

University of Birmingham

Status and phase: Enrolling; Phase 3

Conditions: Surgical Site Infection; Surgery; Surgery--Complications; Surgical Wound Infection

Treatments: Other: NONE (Control); Drug: 2% alcoholic chlorhexidine skin prep (SKIN PREP); Device: Gentamicin-impregnated implants/ sponges (SPONGE); Device: Iodophor Antimicrobial Incise Drapes (DRAPE)

Study type: Interventional

Funder types: Other

Identifiers

NCT03838575

RG_18-186

Details and patient eligibility

About

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.

Full 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:

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.

Enrollment: 6,610 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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6,610 participants in 8 patient groups

A - NONE (Control)

Active Comparator group

Description:

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.

Treatment:

Other: NONE (Control)

B - SKIN PREP

Active Comparator group

Description:

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

Treatment:

Drug: 2% alcoholic chlorhexidine skin prep (SKIN PREP)

C - DRAPE

Other group

Description:

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

Treatment:

Device: Iodophor Antimicrobial Incise Drapes (DRAPE)

D - SPONGE

Active Comparator group

Description:

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

Treatment:

Device: Gentamicin-impregnated implants/ sponges (SPONGE)

E - SKIN PREP and DRAPE

Other group

Description:

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)

Treatment:

Device: Iodophor Antimicrobial Incise Drapes (DRAPE)

Drug: 2% alcoholic chlorhexidine skin prep (SKIN PREP)

F - SKIN PREP and SPONGE

Active Comparator group

Description:

See descriptions in single arms (B \& D)

Treatment:

Device: Gentamicin-impregnated implants/ sponges (SPONGE)

Drug: 2% alcoholic chlorhexidine skin prep (SKIN PREP)

G - DRAPE and SPONGE

Other group

Description:

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)

Treatment:

Device: Iodophor Antimicrobial Incise Drapes (DRAPE)

Device: Gentamicin-impregnated implants/ sponges (SPONGE)

H - SKIN PREP and DRAPE and SPONGE

Other group

Description:

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)

Treatment:

Device: Iodophor Antimicrobial Incise Drapes (DRAPE)

Device: Gentamicin-impregnated implants/ sponges (SPONGE)

Drug: 2% alcoholic chlorhexidine skin prep (SKIN PREP)