Placement of Antibiotic Powder in Wounds During the Emergency Room

Официальное название

Placement of Antibiotic Powder in Wounds During the Emergency Room (POWDER) Study

Обзор

This is the first prospective controlled study to determine whether the topical application of vancomycin powder reduces infection-related complications when applied to open fracture injuries in the acute emergency department setting.

Подробное описание

Open fracture injuries are highly susceptible to infection and infection-related complications. The current routine treatment for these injuries includes the use of systemic IV antibiotics. However, open fracture injuries often have compromised blood supply, reducing the amount of antibiotic that reaches the target tissue while increasing risk of injury to non-target organs. This trial aims to evaluate the effectiveness of early application of a topical vancomycin antibiotic powder on open fracture wounds, in combination with the usual treatment, in reducing the risk of infection seen in these injuries.

Вмешательства

• Препарат Vancomycin
  2 vials of Vancomycin 1g powder will be applied topically to the open fracture wound site.

Первичные конечные точки

• Deep-space infection rate at prophylaxis site [Срок оценки: Within one year of injury date]

Вторичные конечные точки (4)

• Superficial infection rate requiring post-operative medical intervention [Срок оценки: Within one year of injury date]
• Unplanned repeat visit rate [Срок оценки: Within one year of injury date]
• Readmission rate for open fracture infection [Срок оценки: Within one year of injury date]
• Death rate [Срок оценки: Within one year of injury date]

Критерии участия

Критерии включения

• Subject or Legal Authorized Representative (LAR) is willing and able to provide written informed consent.
• Adult 18 years of age or older.
• Open fracture of the humerus, radius, ulna, femur, tibia, and/or fibula.
• 24 hours or less has elapsed from the estimated time of injury to study intervention.

Критерии исключения

• Time from injury > 24 hours.
• Subjects who have received acute operative care (e.g., washout in the operating room or fixation) of the open fracture at an outside facility.
• Subject or LAR speaks neither English nor Spanish. Note that subjects that are unable to participate in the consent process (e.g. intoxication, poly-trauma, will be enrolled into the observational arm where passive data collection will occur).
• High-potency antibiotic powder or solution applied to the wound prior to enrollment. Simple ointment (i.e., bacitracin ointment) or antibiotic-impregnated dressings will be permitted.
• Documented allergies or serious reactions to vancomycin. History of uncomplicated "red man syndrome" will not be considered a reason for exclusion.
• Pregnant subjects. If the subject is a female of childbearing potential, and she states that she is likely to be pregnant, a pregnancy test will be performed; if negative, the subject will be eligible for enrollment.
• Prisoners.
• Participation in other clinical research involving investigational antimicrobial products within 30 days of randomization.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 2 центра

• University Hospital — San Antonio
• San Antonio Military Medical Center — San Antonio

Идентификаторы

NCT: NCT03765567 · HSC20180520H · W81XWH-18-2-0074

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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