MARLIN: Stratified, Multi-arm, Multi-stage Factorial Randomised Platform Trial Aiming to Reduce the Incidence of Post-operative Surgical Site Infection (SSI).
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10,092
- 试验地点
- 9
- 主要终点
- Surgical site infection
研究概览
简要总结
MARLIN is a stratified, multi-arm, multi-stage factorial randomised platform trial aiming to reduce the incidence of post-operative surgical site infection (SSI).
详细描述
MARLIN's primary objective is assess whether different interventions used at three different time points during the participant's operative care (pre-, intra- and post-operatively) can reduce SSI at 30 days in patients undergoing abdominal surgery. MARLIN will assess the clinical effectiveness in both clean-contaminated wounds and contaminated or dirty wounds and will assess the interventions being assessed individually and in combination.
Patients (adults and children) undergoing surgery with abdominal incision of at least ≥5cm, with an anticipated clean-contaminated or contaminated or dirty wound, undergoing emergency or elective, and open or laparoscopic surgery are eligible. Participants will be recruited from hospitals within the National Institute for Health and Care Research Global Surgery Unit (NIHR GSU) network (i.e. hospitals in Benin, Rwanda, Ghana, India, Mexico, Nigeria, South Africa).
Interventions will be introduced at the preoperative window, intra-operatively and postoperatively as it is not yet known which if any of these timed intervention periods are most effective. It is planned that only one intervention will be introduced in each window. This format will allow testing for interaction between interventions including cumulated benefit. It will also enable unsuccessful interventions to be withdrawn and potentially substituted. This is a pragmatic design and wherever possible, standard care will be provided in the control arm.
After patient eligibility has been confirmed and informed consent has been obtained, patients will be randomised into the MARLIN trial by a member of the MARLIN research team at the site. Randomisation will occur within 72 hours prior to the patient's operation. Patients will be randomised dependent on which arms are available at the randomising site, and in which they consent to participate (i.e. it is possible for patients to 'opt out' of one or more of the intervention timepoints).
Patients may be randomised to receive:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Participants should be randomised by a member of the research team who will not be performing the any aftercare, including trial-specific follow-up assessment(s). The follow-up assessor at 30 days will therefore be blinded to treatment allocation until after the completion of follow-up. Unless otherwise instructed by a research ethics committee, the operative notes should not include details of the specific intervention used.
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with at least one abdominal incision that is ≥5cm (open or laparoscopic extraction site), with an anticipated clean-contaminated, contaminated, or dirty surgical wound. Definitions and examples of contamination are given in Table
- •Patients undergoing emergency (surgery on an unplanned admission) or elective (surgery on a planned admission) operations.
- •Any operative indication for abdominal surgery (excluding caesarean section; see exclusion criteria).
- •Patient able and willing to provide written informed consent (signature or a fingerprint) prior to surgery (including emergency cases).
- •Patients aged 5 years and over. (This criteria MUST be made country-specific. Each country will decide the lower (and upper, if applicable according to local regulations age limit for the trial. This will be dependent on country-specific regulatory approvals. Age eligibility will vary by country.)
排除标准
- •Patient unable to complete post-operative follow-up (i.e., will not be contactable after discharge).
- •Patients undergoing clean surgical procedures.
- •Patients undergoing an obstetrics procedure, including caesarean sections.
结局指标
主要结局
Surgical site infection
时间窗: Within 30 days of surgery
The primary outcome is surgical site infection (SSI) within 30 days post-surgery, defined according to Centre for Disease Control criteria collected using an adapted, validated Wound Healing questionnaire (TALON).
次要结局
- Length of hospital stay(Within 30 days of surgery)
- Re-operation for SSI(Within 30 days of surgery)
- Mortality(Within 30-days post-surgery)
- Return to normal activities(Within 30 days of surgery)
- Unplanned wound opening(Within 30 days of surgery)
- Surgical site infection(At or prior to discharge from hospital, usually within approximately 7 days of surgery)