Incisional Negative Pressure Wound Therapy to Reduce Infection and Complications in High-Risk Fractures

Официальное название

Incisional Negative Pressure Wound Therapy to Reduce Infection and Complications in High-Risk Fractures: A Multicenter Randomized Controlled Trial

Обзор

This is a multi-center, pragmatic, parallel arm randomized controlled trial (RCT) of 352 patients with high-risk open or closed tibial plateau fracture, high-risk open or closed tibial pilon fracture, or open tibial shaft fracture with incision \>3cm. Eligible participants will be randomized to receive either incisional negative pressure wound therapy (NPWT) or a non-suction standard-of-care wound dressing for their definitive wound management. The primary outcome will be a composite outcome to evaluate clinical status 3 months after randomization.

Вмешательства

• Устройство Incisional Negative Pressure Wound Therapy (NPWT)
  Participants in the treatment group will be standardized and will receive incisional NPWT using the any incisional VAC system that can apply 75-125mmHg continuous suction to the incision. The VAC sponge will be placed over the surgical wound at least 2cm in width and \>3cm in length.

Первичные конечные точки

• Complication composite outcome [Срок оценки: 3 months]

Критерии участия

Критерии включения

• All open or closed tibial plateau or pilon fractures treated operatively with internal fixation at high risk for complication. Any open Gustilo Type I, II or IIIA tibial shaft fracture treated definitively with internal or external fixation with or without ipsilateral leg compartment syndrome if at least one wound is primarily closed.
• We define high-risk fractures as those that are either:

• Closed fracture initially treated with an external fixator (with or without limited internal fixation) and treated definitive more than 3 days later after swelling has resolved;
• Any open type I, II or IIIA fracture, regardless of timing of definitive treatment;
• Any tibial plateau fracture associated with ipsilateral leg compartment syndrome fasciotomy wounds that has at least one wound primarily closed
• Requiring incision for fixation or debridement of 3 cm or greater.
• Patients 18 years of age or older

Критерии исключения

• The study injury is already infected at time of study enrollment.
• Patient is unable to receive incisional NPWT for any reason.
• Patients who have already had definitive fixation prior to enrollment in the study.
• Severe problems with maintaining follow-up (e.g., patients who are homeless at the time of injury or those who are intellectually challenged without adequate family support or who are prisoners).
• The study injury is a Gustilo Type IIIB or IIIC open fracture.

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

Лечение

Центры проведения

США · 6 центров

• University of Maryland R Adams Cowley Shock Trauma Center — Baltimore
• University of Maryland Shock Trauma/Capitol Regions — Baltimore
• Dartmouth-Hitchcock Medical Center — Lebanon
• Vanderbilt University — Nashville
• UTHealth/McGovern Medical School — Houston
• Inova Fairfax MEdical Campus — Falls Church

Идентификаторы

NCT: NCT06337292 · IRB00440042

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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