Addition of Pre-wound Closure Povidone Iodine Wash Versus Direct Wound Closure Effect on Surgical Site Infections: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 760
- 试验地点
- 1
- 主要终点
- Surgical Site Infection Incidence
研究概览
简要总结
A Randomized controlled trail to To assess the efficacy of povidone-iodine wash before wound closure in preventing surgical site infections.
详细描述
Surgical site infections are post-operative infections of the incision or organ or space that was included in the surgical field. Incisional surgical site infections (SSIs) are a growing healthcare challenge.
Currently, up to 10% of surgical procedures may be complicated by an SSI [3]. Not only do SSIs lead to worse patient outcomes, but they also account for a large proportion of healthcare expenditure.
In the United Kingdom alone, SSIs are estimated to cost the National Health Service 1 billion pounds annually.
The problem is further compounded in low- and middle-income countries (LMICs) where the prevalence of antibiotic-resistant infections is increasing, and national healthcare budgets are strained.
In fact, SSIs are estimated to account for additional costs of up to $30,000 in LMICs.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
A statistician not directly involved in the study or analysis will prepare a computer-generated randomization sequence. No blocking will be used. The sequence will be provided to the trialists in the form of serially numbered opaque envelopes containing details of either the intervention or the control and a random identifier.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients (≥ 18 years old)
- •Open and minimally invasive surgeries
- •Emergency (any unplanned admission) and elective (planned admission) surgical procedures
- •Clean, Clean-Contaminated, Contaminated, Dirty wounds
- •Inclusion surgery list according to Current Procedural Terminology (CPT) National Healthcare Safety Network (NHSN) operative procedure code mapping
排除标准
- •Povidone-iodine allergy
- •Surgeries for infected wounds.
- •Exclusion surgery list according to Current Procedural Terminology (CPT) National Healthcare Safety Network (NHSN) operative procedure code mapping.
研究组 & 干预措施
Intervention
The use of 10% surgical povidone iodine to wash the wound directly after fascial closure and before wound closure
干预措施: 10% Povidone Iodine (Drug)
结局指标
主要结局
Surgical Site Infection Incidence
时间窗: 30 days
Using the CDC Checklist for Superficial and deep Surgical site infection.
次要结局
- Readmission and reoperations related to Surgical site infection(30 Days)
- Infectious complications(30 Days)
- Microbiology culture and sensitivity results(30 Days)
- Cost analysis(30 Days)
- Local adverse events for povidone-iodine application(30 Days)
- Post-operative morbidity and mortality(30 Days)
- Length of hospital stay(30 Days)
研究者
Walid Ahmed Abdel-Ghany
Professor
Ain Shams University