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临床试验/NCT05745467
NCT05745467撤回4 期

Exploring the Impact of Nasal Povidone Iodine for Prevention of Intraoperative Spread of SARS-CoV-2 Nucleic Acid Particles and Assessment of Infectivity of Transmitted Particles

University of Iowa0 个研究点开始时间: 2024年7月3日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
撤回
主要终点
Detection of SARS-CoV-2 nucleic acid particles in proximal and distal operating room locations using real time PCR in SARS-CoV-2 acutely infected patients receiving perioperative application of nasal 5% povidone iodine.

研究概览

简要总结

The primary aim is to test whether preoperative asepsis with 5% nasal povidone iodine versus no preoperative asepsis with 5% nasal povidone iodine reduces proximal and distal SARS-CoV-2 transmission in operating rooms among patients who are acutely infected with SARS-CoV-2. The secondary aim is to test viral infectivity.

详细描述

Primary Objectives:

The primary aim is to test whether preoperative asepsis versus no preoperative asepsis reduces intraoperative SARS-CoV-2 transmission among patients acutely infected with SARS-CoV-2 (within 10 days of surgery).

Primary Endpoints:

Proximal and distal contamination with SARS-CoV-2 via nucleic acid detection.

Each patient will undergo induction of anesthesia and stabilization for the planned procedure. Approximately 50% of patients will have received 3M 5% povidone iodine 2 times prior to incision (each nares treated 2 times, 4 swabs, a total of 1 vial per patient) with the first time being before anesthesia administration and the second after anesthesia administration or usual care. Then, the investigators will sample locations for which the investigators detected SARS-CoV-2 transmission during the pilot: anesthesia work area reservoirs (anesthesia attending and assistant hands, patient nasopharynx, axilla and groin, and the anesthesia machine vaporizer at case end and at case start, and the patient intravenous stopcock at case end) and the operating room environment (anesthesia cart handles, anesthesia provider mouse, top of anesthesia cart, anesthesia suction cannister, circulating nurse mouse, walls at 6 feet, walls at the base of the floor, and air intake registers). A subset of all samples except patient nasopharynx, axilla, and groin at case beginning will be combined and processed together. Subsets of patient nasopharynx, axilla, and groin samples at case beginning will be combined and processed together. All samples will be stored separately. All samples will be collected before cleaning, transported to the laboratory, and analyzed using real-time PCR for viral detection. Samples will be saved for analysis of viral infectivity and for potential evaluation of each individual sample.

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
None

入排标准

年龄范围
18 Years 至 105 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients
  • Undergoing surgery (elective, urgent, or emergent)
  • Requiring general anesthesia
  • Acutely infected (<= 10 days from diagnosis) with SARS-CoV-2

排除标准

  • Not general anesthesia
  • Not acutely infected (<= 10 days from diagnosis) with SARS-CoV-2
  • Allergy to povidone iodine
  • Unable to provide consent
  • Pregnant individuals

研究组 & 干预措施

Povidone Iodine

Experimental

5% povidone iodine will be swabbed in patients' nares (experimental group), one in each nostril, twice before incision.

干预措施: Povidone Iodine 5% Soln,Top,Kit (Drug)

结局指标

主要结局

Detection of SARS-CoV-2 nucleic acid particles in proximal and distal operating room locations using real time PCR in SARS-CoV-2 acutely infected patients receiving perioperative application of nasal 5% povidone iodine.

时间窗: 4 hours

The proximal (anesthesia attending and assistant hands, patient nasopharynx, axilla, and groin, anesthesia machine vaporizer, and patient intravenous stopcock) and distal (anesthesia cart handles, anesthesia provider mouse, top of anesthesia cart, anesthesia suction canister, circulating nurse house, walls at 6 feet and at base of the floor, and air intake registers) locations will be evaluated with real time PCR for the presence of SARS-CoV-2 nucleic acid particles. This will be evaluate for patients receiving normal care and for patients receiving nasal 5% povidone iodine preoperatively. All of the samples except for patient nasopharynx, axilla, and groin at case beginning will be pooled together and evaluated. Patient nasopharynx, axilla, and groin at case beginning will be evaluated separately.

次要结局

  • Viral load of the proximal and distal samples collected for the primary outcome will be evaluated with tissue cultures using Vero E6 cells and plaque counting.(4 hours)

研究者

申办方类型
Other
责任方
Sponsor

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