ISRCTN78305317进行中（未招募）未知
ROSSINI 2: 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
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 6,610
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 24/03/2023:
- •1. Patients undergoing an abdominal operation, these include colorectal, hepatobiliary, upper GI, urological, vascular, or gynaecological operations
- •2. Patients undergoing abdominal operations (open or laparoscopic extraction site) with a planned incision of at least 5 cm
- •3. Patients aged 16 years or older
- •4. Patients able and willing to undergo a wound assessment at day 30-37 after surgery
- •5. Patients able and willing to give written informed consent
- •6. All contamination strata, including clean, clean-contaminated, contaminated or dirty surgery
- •7. Patients undergoing planned (elective or expedited) or unplanned (emergency) surgery
- •Previous inclusion criteria:
- •1. Patients undergoing colorectal, hepatobiliary, upper GI, urological, vascular, or gynaecological operations
- •2. Patients undergoing abdominal operations (open or laparoscopic extraction site) with a planned incision of at least 5 cm
- •3. Patients aged 16 years or older
- •4. Patients able and willing to give written informed consent
- •5. All contamination strata, including clean, clean-contaminated, contaminated or dirty surgery
- •6. Patients undergoing planned (elective or expedited) or unplanned (emergency) surgery
排除标准
- •1. Previous laparotomy within 3 months prior to randomisation
- •2. 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
- •3. 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
研究者
相似试验
Unknown
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