Incisional Negative Pressure Therapy to Prevent Animal Induced Wound Infection

Официальное название

A Study on the Application of Incisional Negative Pressure Therapy in Reducing the Risk of Infection in Animal Induced Injury Patients With Primary Wound Closure

Обзор

Animal injuries are a significant public health issue, with the most common being bites or scratches from cats and dogs. Every year, over 40 million people in China are bitten or scratched by cats and dogs, which can lead to wound infections and even systemic complications, with infection rates ranging from 10% to 80%. However, there is still no better way to reduce wound infection rates in current clinical studies and guidelines. Incisional negative pressure wound therapy (iNPWT) is a new wound treatment technology developed in recent years. It creates a negative pressure environment on sutured or closed wounds, helps to fix the edges of the incision together, reduce lateral tension on the wound, stimulate blood perfusion at the edge of the wound, remove fluid from the wound, and act as an external pollution barrier. INPWT has been widely used for postoperative wound healing in surgery, but there is currently a lack of effective clinical trials on its ability to prevent wound infections caused by animal injuries and promote wound healing. This study aims to apply iNPWT technology to the wounds of patients with rabies grade III exposure who underwent primary suturing, and compare it with wounds covered with ordinary gauze after previous primary suturing to determine whether it can help reduce postoperative incision infection rates and promote wound healing. This will provide high-quality clinical evidence for the widespread use of wound management in rabies grade III exposure patients in the future.

Вмешательства

• Устройство incisional negative pressure wound technology
  Negative pressure device used directly on closed or sutured incisions

Первичные конечные точки

• Wound infection (WI) [Срок оценки: <4 weeks]

Вторичные конечные точки (3)

• Delayed healing of wounds (DHW) [Срок оценки: 2-4 weeks]
• Wound reprocessing (WR) [Срок оценки: ≤4 weeks]
• other wound complication [Срок оценки: ≤4 weeks]

Критерии участия

Критерии включения

• Limds injuries caused by animals, first or second animal injury to Grade III exposed patients, with deep wounds reaching the fat layer, tendons, and even penetrating injuries.
• Patients with wounds>2cm and severe injuries that even require surgical treatment.

Критерии исключения

• Missing or incomplete follow-up data within 30 days.
• Patients who have been infected with wounds or have been injured for more than 8 hours before seeking medical attention.
• Acupuncture like wound (<2mm).
• Patients with whole skin detachment.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Emergency Department of Peking University First Hospital — Пекин

Публикации

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• Fernandez Vecilla D, Aspichueta Vivanco C, Ugalde Zarraga E, Diaz de Tuesta Del Arco JL. Wound infection caused by Pasteurella canis and Neisseria animaloris after a dog bite. Rev Esp Quimioter. 2023 Dec;36(6):635-637. doi: 10.37201/req/035.2023. Epub 2023 Sep 29. No abstract available. PMID 37772341
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• Miller C. The History of Negative Pressure Wound Therapy (NPWT): From "Lip Service" to the Modern Vacuum System. J Am Coll Clin Wound Spec. 2013 Nov 28;4(3):61-2. doi: 10.1016/j.jccw.2013.11.002. eCollection 2012 Sep. PMID 26236637
• Fleischmann W, Strecker W, Bombelli M, Kinzl L. [Vacuum sealing as treatment of soft tissue damage in open fractures]. Unfallchirurg. 1993 Sep;96(9):488-92. German. PMID 8235687
• Morykwas MJ, David LR, Schneider AM, Whang C, Jennings DA, Canty C, Parker D, White WL, Argenta LC. Use of subatmospheric pressure to prevent progression of partial-thickness burns in a swine model. J Burn Care Rehabil. 1999 Jan-Feb;20(1 Pt 1):15-21. doi: 10.1097/00004630-199901001-00003. PMID 9934631

Идентификаторы

NCT: NCT06558942 · 2024SF59

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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