Идёт набор NCT06378359

Effectiveness of Screening and Decolonization of S. Aureus to Prevent S. Aureus Surgical Site Infections in Surgery Outpatients

— Наблюдательное Staphylococcus Aureus Colonization Surgical Site Infections Healthcare Associated Infections

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Screening and decolonization for SA carriers with the 3 drug bundle, No screening for SA, no screening, Nasal povidone-iodine on surgery day plus 2 CHG pre-op showers without screening..
Кому может быть актуально: Состояния в реестре: Staphylococcus Aureus Colonization, Surgical Site Infections, Healthcare Associated Infections. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The purpose of the study is to determine the effectiveness, safety, and health-care utilization and costs of a preoperative Staphylococcus aureus (SA) screening and decolonization bundle, (5 days of nasal mupirocin ointment, chlorhexidine gluconate (CHG) body wash, and CHG mouth rinse), in eradicating SA carriage compared to other SA decolonization approaches. The study will conduct a single center pilot trial to compare efficacy of different SA decolonization approaches in pre-surgical patients, in eradicating SA carriage, after obtaining informed consent. The study will compare four different approaches, Arm 1) screen for SA carriage and using the three-drug decolonization bundle for 5 days among patients with SA colonization, non SA carriers in this arm will get two pre-op showers with CHG soap, Arm 2) all participants receive the three drug decolonization bundle, Arm 3) all receive pre-op nasal povidone iodine the day of surgery plus two pre-op showers with CHG soap, and Arm 4) all receive nasal alcohol gel the day of surgery plus two pre op showers with CHG soap. The primary efficacy outcome will be eradication of SA colonization at all 5 body sites. Secondary outcomes will be SA surgical site infections (SSIs), all SSIs, and SA healthcare associated infections (HAIs). The study will also compare eradication of SA from each of the 5 body sites as a secondary outcome.

Вмешательства

Другое Screening and decolonization for SA carriers with the 3 drug bundle
nasal mupirocin, chlorhexidine gluconate (CHG) mouth rinse and CHG soap showers x 5 days and non-SA carriers receive 2 CHG pre-op showers
Другое No screening for SA
All receive the 3 drug bundle, Nasal mupirocin, chlorhexidine gluconate (CHG) mouth rinse, and CHG body wash
Другое no screening
giving pre-surgical patients the three drug decolonization bundle without screening
Другое Nasal povidone-iodine on surgery day plus 2 CHG pre-op showers without screening.
Nasal povidone-iodine on surgery day plus 2 CHG pre-op showers without screening.
Другое Nasal alcohol gel on surgery day plus 2 CHG pre-op showers without screening
Nasal alcohol gel on surgery day plus 2 CHG pre-op showers without screening

Первичные конечные точки

Efficacy in eradicating Staphylococcus aureus (SA) [Срок оценки: baseline]

Критерии участия

Критерии включения

Eligible participanst are outpatients in orthopedic, urology, neuro, otolaryngology, plastic and general surgery and OB/GYN clinics who are scheduled to undergo surgery at participating trial sites.
Anticipated surgery ≥ 10 days after the date of enrollment, to allow time for completion of baseline cultures and the decolonization protocol.
Age ≥ 18 years
Ability to complete the decolonization protocol pre-operatively as an outpatient.
No antibiotic therapy at the time of, or seven days prior to, baseline cultures, and no subsequent antibiotic therapy prior to the surgical procedure. Standard pre-op antibiotic prophylaxis given.
Patients are having skin incisions as part of their scheduled surgical procedure.