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临床试验/NCT05647252
NCT05647252已完成3 期

General Skin and Nasal Decolonization With Octenisan® Set Be-fore and After Elective Orthopedic Surgery in Selected Patients at Elevated Risk for Revision Surgery and Surgical Site Infections

Balgrist University Hospital1 个研究点 分布在 1 个国家目标入组 1,086 人开始时间: 2023年2月27日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
1,086
试验地点
1
主要终点
Wound problems after elective surgery

研究概览

简要总结

The general decolonization of the human body surface by industrial antiseptic agents, before elective surgery is recommended by the World Health Organization (WHO).

A specific randomized-controlled trial specifically among high-risk adult orthopedic patients for infection has not been performed.

In this single-center, prospective, randomized, and controlled superiority trial, which is planned over a period of two years, we target on an orthopedic patient population with an elevated risk for revision surgery and surgical site infections

详细描述

The general decolonization of the human body surface and, of adjacent pathogen reservoirs such as the nose, by industrial antiseptic agents by the World Health Organization (WHO) for the risk reduction of superficial and deep surgical site infection (SSI). Such a decolonization is regarded as evidence-based in the majority of randomized, and before-after trials, since two decades, although negative studies also exist.

In the orthopedic field, this decolonization is likely to be more effective in elective patients with a proven body colonization of Staphylococcus aureus. The decolonization might be equally efeective in orthopedic patients with an inherent high risk for SSI, for which the majority of future SSI pathogens are skin commensals and S. aureus. These (eventual and future) pathogens of SSI are accessible to the topical agents during the index surgery, if the patients are well instructed and know how to decolonize themselves.

In contrast, this pre-surgical decolonization is only a supplementary measure in the bundle of all combined efforts to prevent revision surgery for infection. Its individual power is limited for young, healthy individuals, for SSIs caused by pathogens from the internal body sites (intestinal, urinary, gynecologic regions), infections acquired on the surgical ward, and in settings with less specialized surgeries and a low volume of surgical experience. Hence, in trials including all patients (or only those carrying S. aureus), the beneficial effect of decolonization can be diluted and provoke an additional costly and cumber-some organizational procedure for the majority of patients with low to moderate SSI risks.

Moreover, many surgical site infections in orthopedic surgery, especially in implant-related surgery, are more due to coagulase-negative staphylococci (CoNS) than for S. aureus.

The hallmark of the CoNS group is S. epidermidis with approximatively 70% resistance (in Switzerland) to standard prophylactic antibiotic agents9, As S. epidermidis is part of the normal human flora, typically the skin flora, and, only becomes pathogenic under certain conditions, a screening for this microorganism is not feasible in common practice,. while the prophylaxis-resistant part of all orthopedic SSI pathogens is at 30-50%.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years
  • Patients with an age ≥ 80 years (as considered particularly at risk for SSI)
  • Elective orthopedic surgery at the Balgrist
  • Chronic immune-suppression (diabetes mellitus, active cancer, cirrhosis CHILD C, renal dialysis, untreated HIV disease, medicamentous immune-suppression equivalent to prednisone ≥ 10 mg/day)
  • Elective surgery in ischemic skin (e.g. major amputations)
  • Elective surgery on non-diabetic and non-infected ulcerated skin
  • Tumor (oncologic) orthopedic surgery
  • ASA-Scores 3-4 points

排除标准

  • Elective revision orthopedic surgery due to orthopedic infection within the last 12 months in the same area of surgery
  • Emergency surgery (defined as planned surgery within the next 48 hours)
  • Surgery on infected skin; or surgery under antibiotic treatment for any reason
  • "Diabetic foot surgery" (distinct clinical entity; defined as below the ankle)
  • Body mass index ≥ 35 kg/m2 (anticipated difficulty of effective decolonization)
  • Pregnancy (formality reasons)
  • Intolerance or allergy to octenidin and/or ingredients in the Octenisan® set
  • Use of any other topical antiseptic agents other than Octenisan® set (except for the duration of one day)
  • Patient unable to understand; or under legal guardian for medical decisions
  • Anticipated clinical follow-up of less than 6 weeks after surgery.
  • ASA-Scores 1-2, and ASA-Score 5 (high risk of postoperative complications)
  • Known skin colonization with antibiotic-multiresistant Gram-negative organisms defined by infection control protocols of Switzerland1

研究组 & 干预措施

Decolonization

Experimental

This study will be performed with an existing "set" manufactured by Schülke & Mayr GmbH. The distribution of octenisan® wash lotion and octenisan® nasal gel in the form of a set (octenisan® set) largely streamlines and facilitates the application and compliance.

The duration of pre-surgical decolonization is planned to be five days. However, when this pre-surgical time period is too short, the decolonization may also start at least 3 days before surgery and be contin-ued up to 2 days post-surgery.

During the post-surgery application, the patient will be washed with water and Octenisan® set by their treating nurses. The patient will also return the empty/used set and answer to a short questionnaire during their hospital stay. The study team will recuperate the questionnaire during hospitalization.

干预措施: Whole Body and nasal decolonization with octenidin (Octenisan Set) (Drug)

Decolonization

Experimental

This study will be performed with an existing "set" manufactured by Schülke & Mayr GmbH. The distribution of octenisan® wash lotion and octenisan® nasal gel in the form of a set (octenisan® set) largely streamlines and facilitates the application and compliance.

The duration of pre-surgical decolonization is planned to be five days. However, when this pre-surgical time period is too short, the decolonization may also start at least 3 days before surgery and be contin-ued up to 2 days post-surgery.

During the post-surgery application, the patient will be washed with water and Octenisan® set by their treating nurses. The patient will also return the empty/used set and answer to a short questionnaire during their hospital stay. The study team will recuperate the questionnaire during hospitalization.

干预措施: Questionnaire for study participants immediately after the decolonization (Behavioral)

结局指标

主要结局

Wound problems after elective surgery

时间窗: Until week 6 after surgery

Wound problems (dehiscence, seroma, hematoma, necrosis) occurring after surgery

Remission (and inversely surgical site infection)

时间窗: At 6 weeks after elective orthopedic surgery; or at 1 year for surgeries with orthopedic implants

Remission is defined as the absence of clinical, anamnestic, radiologic or laboratory signs of infection.

次要结局

  • Adverse events(At 6 weeks after elective orthopedic surgery; or at 1 year for surgeries with orthopedic implants)
  • Unplanned revision surgery for non-infection problems in same time period(At 6 weeks after elective orthopedic surgery; or at 1 year for surgeries with orthopedic implants)
  • Subjective opinion and information on the decolonization(A day within one week after surgery (during the hospitalization))

研究者

发起方
Balgrist University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ilker Uckay

Prof Dr. med. Ilker Uçkay

Balgrist University Hospital

研究点 (1)

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