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.
试验速览
- 阶段
- 3 期
- 入组人数
- 6,610
- 试验地点
- 2
- 主要终点
- SSI rate up to 30 days after surgery as defined according to the 2017 Centers for Disease Control (CDC) and Prevention Criteria.
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: NONE (Control) (Other)
B - SKIN PREP
Mechanism: A broad-spectrum antiseptic to clean and prepare the skin prior to surgery.
Supplier: BD
干预措施: 2% alcoholic chlorhexidine skin prep (SKIN PREP) (Drug)
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
干预措施: Iodophor Antimicrobial Incise Drapes (DRAPE) (Device)
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
干预措施: Gentamicin-impregnated implants/ sponges (SPONGE) (Device)
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)
干预措施: 2% alcoholic chlorhexidine skin prep (SKIN PREP) (Drug)
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)
干预措施: Iodophor Antimicrobial Incise Drapes (DRAPE) (Device)
F - SKIN PREP and SPONGE
See descriptions in single arms (B & D)
干预措施: 2% alcoholic chlorhexidine skin prep (SKIN PREP) (Drug)
F - SKIN PREP and SPONGE
See descriptions in single arms (B & D)
干预措施: Gentamicin-impregnated implants/ sponges (SPONGE) (Device)
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)
干预措施: Iodophor Antimicrobial Incise Drapes (DRAPE) (Device)
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)
干预措施: Gentamicin-impregnated implants/ sponges (SPONGE) (Device)
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)
干预措施: 2% alcoholic chlorhexidine skin prep (SKIN PREP) (Drug)
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)
干预措施: Iodophor Antimicrobial Incise Drapes (DRAPE) (Device)
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)
干预措施: Gentamicin-impregnated implants/ sponges (SPONGE) (Device)
结局指标
主要结局
SSI rate up to 30 days after surgery as defined according to the 2017 Centers for Disease Control (CDC) and Prevention Criteria.
时间窗: 30 days post surgery
The CDC definition will be used in ROSSINI 2 to identify deep incisional or superficial incisional SSIs.
次要结局
- 30-day postoperative mortality rate (POMR).(Within 30 days post surgery)
- Health-related, preference-based quality of life(Baseline, Day 7, Day 30 and if applicable Ongoing SSI (Day 60, 90, 120 etc))
- Hospital re-admission for wound related complications within 30 days.(Within 30 days post surgery)
- Occurrence of unplanned wound reopening and/or re-operations within 30 days post-operation.(Within 30 days post surgery)
- Cost-effectiveness(To complete at Day 30 and if applicable Ongoing SSI (Day 60, 90, 120 etc))
- 30-day postoperative wound complication rate.(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.))
- Serious Adverse Events up to 30 days (wounds or intervention-related only).(Within 30 days post surgery)