Iodine-Povidone Alcohol Compared to Chlorhexidine Alcohol as Preoperative Antiseptics in Major Abdominal Elective Clean Contaminated Surgery
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Surgical site infection
研究概览
简要总结
Pragmatic randomized clinical trial comparing Iodine Povacrylex based on alcohol to Chlorhexidine also based on alcohol in efficacy and security to diminish frequency of surgical site infections in major abdominal elective clean contaminated wounds. Will be held in a third level university, high volume national public hospital in San Salvador, El Salvador.
详细描述
Preoperative antiseptic Chlorhexidine based on alcohol has been established as gold standard of care for clean contaminated wounds. It was compared to Iodine solutions non-alcohol based. There is a question about alcohol based solution was a confounder in the comparison. The aim of this study is to compare the efficacy of both solutions alcohol based, 0.7% iodine povacrylex plus 74% alcohol, against gluconate chlorhexidine 2% plus 70% alcohol, in clean contaminated wounds, in major abdominal elective surgeries, in a wider range than colorectal surgeries, Materials and methods. With a pragmatic randomized, phase 4, controlled clinical trial. Comparison of two antiseptic solutions, using manufacturer (3M) sterile appliers' for both products, Food and Drugs Agency approved.
Quality of data will be assured by first training all surgeons and residents besides researchers in the study protocol for protocol compliance in subject identification, randomization moment, and follow up. There is a plan for weekly monitoring of protocol compliance, and monthly data monitoring and auditing from Faculty of Medicine Research Unit.
Monitoring and auditing will comply protocol compliance and data integrity against subject's medical records and random interviews of patients in their post-surgical control.
Surgical Site Infection definitions are those taken from Centers for Disease Control definitions.
Standard Operating Procedures will be established in all moments of the trial, from subject identification, informed consent, recruitment, randomization process in the operating room, and data collection in pre specified files for data collection and data management. Protocol compliance and Standard Operating Procedures compliance will be monitored by Principal Investigator constantly. Report of adverse events will be done in accordance to Salvadoran National ethics committee Standard Operating Procedures as also any other communication such as protocol deviance or amendments. Previous research has not reported adverse events, but we will be expectant to their appearance.
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
- Single (Participant)
盲法说明
Participant will be randomized through a selection of a sealed envelope with computer generated random numbers by the Operating Room nurse, and the substance will be applied when participant will be already with anesthesia
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective surgery categorized as clean contaminated surgery Major abdominal
排除标准
- •American Society of Anesthesia III-IV
- •Laparoscopic cholecystectomy
- •Inguinal hernias classification I, II
- •Obese subjects with Body Mass Index more than 35 or malnourished
- •immunocompromised subjects
- •neoplasia Preoperative hospital stay more than 7 days allergic to any of the solutions used in the trial
研究组 & 干预措施
Iodine-Povacrylex Alcohol
Iodine Povacrylex 7 MG/ML / Isopropyl Alcohol 0.74 ML/ML: preoperative asepsis with subject already lying down in the operating room, already with anesthesia, before dressing and incision, with single dose applicator of Iodine-povacrylex 7mg/ml plus isopropyl alcohol 0.74 ml/ml (DuraPrep) , fabricated by 3M, as the experimental intervention. Will be applied from the center of the abdomen centrifuge as recommended by the Centers of Disease Control
干预措施: Iodine Povacrylex 7 MG/ML / Isopropyl Alcohol 0.74 ML/ML (Drug)
Chlorhexidine Alcohol
Chlorhexidine Gluconate 20 MG/ML / Isopropyl Alcohol 0.7 ML/ML: preoperative asepsis with subject already lying down in the operating room, already with anesthesia, before dressing and incision, with single dose applicator of chlorhexidine 20 mg/ml plus isopropyl alcohol 0.7 ml/ml (SoluPrep), fabricated by 3M, as the control intervention. Will be applied from the center of the abdomen centrifuge as recommended by the Center of Disease Control
干预措施: Chlorhexidine Gluconate 20 MG/ML / Isopropyl Alcohol 0.7 ML/ML (Drug)
结局指标
主要结局
Surgical site infection
时间窗: Date of event occurs within 30 days after any operative procedure (where day 1 = the procedure date)
infections of the incision or organ or space that occur after surgery.
次要结局
- Superficial surgical site infection(Date of event occurs within 30 days after any operative procedure (where day 1 = the procedure date))
- Deep surgical site infection(Date of event occurs within 30 days after any operative procedure (where day 1 = the procedure date))
- Organ/space SSI(Date of event occurs within 30 days after any operative procedure (where day 1 = the procedure date))
- Skin reaction(Date of event occurs within 7 days after surgery (where day 1= the procedure date)
研究者
Maria-Virginia Rodriguez Funes
Clinical research coordinator
Universidad de El Salvador