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临床试验/NCT04969302
NCT04969302已完成不适用

Examination of the Effect of Skin Antisepsis With Pre-heated Povidone Iodine on Surgical Site Infections: A Quasi-Experimental Study

Eastern Mediterranean University1 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2021年9月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
124
试验地点
1
主要终点
Surgical Site Infection Follow-up Form

研究概览

简要总结

Surgical Site Infections (SSI) develop as a complication of surgical care 30-90 days after surgery without implants and within 1 year after implanted operations. Despite advances in asepsis practices, sterilization methods, surgical technique and antibiotic prophylaxis, SSI is the most important cause of hospital stay, morbidity and even mortality. SSI, which constitutes approximately 20% of healthcare associated infections (HAI) all over the world, is also the HAI with the highest cost. Although it has been reported that 60% of the SSI can be prevented by using evidence-based guidelines, 2-5% of the operated patients develop SSI, the hospital stay of patients with SSI is 7-11 days longer, the risk of death increases 2-11 times, It was reported that the cause of death was direct SSI. In the United States of America (USA), SSI constitutes 31% of HAI, it is seen in 2-5% of inpatients, approximately 160,000-300,000 SSIs occur each year, the most common and costly HAI.Abdominal surgery; It includes the treatment of diseases of organs such as stomach, gall bladder, pancreas, spleen, liver, small intestine and large intestine. It has been reported that the incidence of SSIs after abdominal surgery is 15-25% higher than other types of surgery. In a study conducted by Alcan et al. (2020), 69.8% of nurses stated that they used Povidone Iodine as skin antisepsis. Wistrand et al. (2015) compared preoperative 36 ° C and room temperature 20 ° C Chlorhexidine Gluconate solutions, but reported that there was no difference in bacterial colonization and SSI rates. In their study in Turkey, Gezer et al. (2020) reported that the prevalence of SSI was significantly lower in the Povidone Iodine group heated to 37 ° C before surgery compared to the Povidone Iodine group applied at 25 ° C room temperature.

详细描述

This study was planned in accordance with a single blind randomized controlled full experimental study design to determine the effect of skin antisepsis with Povidone Iodine, which was heated at 37°C and at a room temperature of 20°C in the preoperative period, in reducing surgical site infections in patients who underwent abdominal surgery. Patients who will undergo abdominal surgery at Dr. Burhan Nalbantoğlu State Hospital will comprise the sample of volunteer patients who meet the inclusion criteria and agree to participate in the study. The data of the study was planned to be collected using the Patient Information Form, Surgical Site Infection Follow-up Form and Post Discharge Patient Follow-up Form.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Single (Care Provider)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Being 18 years or older
  • Having undergone abdominal surgery
  • Volunteering to participate in the research
  • Patients without risk of preoperative malnutrition

排除标准

  • Those who test positive for known Povidone Iodine allergy
  • Those who use steroids and immunosuppressive drugs
  • Those who used antibiotics due to infection in the last two weeks (prophylactic antibiotic use is not included in this item since all patients were given antibiotics for prophylaxis on the first day before surgery)
  • Those diagnosed with Diabetes Mellitus (DM)
  • Obese (BMI>30) patients

结局指标

主要结局

Surgical Site Infection Follow-up Form

时间窗: 30 days

The primary outcome of this study was SSI within 30 days of surgery, as defined by the Centers for Disease Control and Prevention. Secondary outcomes were identification of the causative organism, and investigation of clinical factors such as body mass index (BMI), operation time, days of hospitalization, etc. that may be associated with SSI.

次要结局

  • Discharge Follow-up(30 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kerem Yıldız

Principal Investigator

Eastern Mediterranean University

研究点 (1)

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