DRONE-WOUND Study: Severe Infection After Drone-Related Combat Trauma

Официальное название

DRONE-WOUND Study: Tissue Devitalization and Severe Infection Following Drone-Related Combat Trauma: A Prospective Multicenter Observational Cohort Study

Обзор

Drone-related combat injuries have become one of the most devastating mechanisms of injury in modern warfare. These injuries often cause extensive tissue devitalization, contamination, open fractures, vascular injuries, and complex soft tissue damage, which may substantially increase the risk of severe wound infection, multidrug-resistant bacterial infection, repeated surgical procedures, limb loss, and sepsis. However, the relationship between the extent of tissue devitalization and the development of severe infection has not been systematically investigated. The DRONE-WOUND Study is a prospective observational cohort study designed to evaluate the association between tissue devitalization and severe wound infection in patients with drone-related combat trauma. The study will collect detailed clinical, surgical, microbiological, and radiological data from injured patients treated at participating trauma centers. Measures of tissue injury, contamination, surgical management, microbiological findings, and infection outcomes will be analyzed to identify factors associated with severe infection and poor clinical outcomes. The findings of this study are expected to improve understanding of the mechanisms leading to infection after drone-related injuries, support early identification of high-risk patients, and inform future strategies for surgical management, antimicrobial therapy, and infection prevention in combat trauma. Ultimately, the study aims to improve limb salvage, reduce infectious complications, and enhance outcomes for patients with severe drone-related injuries.

Подробное описание

The widespread use of unmanned aerial vehicles (UAVs), including first-person view (FPV) drones and explosive drone-delivered munitions, has fundamentally changed the pattern of combat injuries. Compared with conventional gunshot wounds and traditional blast injuries, drone-related trauma frequently results in extensive soft tissue destruction, deep tissue devitalization, severe contamination, open fractures, vascular injury, and complex multisystem extremity trauma. These injuries often require repeated surgical debridement, prolonged antimicrobial therapy, reconstructive procedures, and extended rehabilitation.

Severe wound infection remains one of the leading causes of morbidity following combat-related extremity trauma. However, the mechanisms linking the extent of tissue devitalization with subsequent infectious complications have not been adequately characterized. Early identification of patients at high risk for severe infection could improve surgical decision-making, optimize antimicrobial stewardship, and reduce the incidence of limb loss, sepsis, and other major complications.

The DRONE-WOUND Study is designed to characterize the relationship between tissue devitalization and severe infection following drone-related combat trauma. The study will prospectively collect standardized clinical, operative, microbiological, and imaging data from patients with combat-related injuries treated at participating trauma centers. Particular attention will be given to the extent of tissue devitalization, contamination, vascular injury, fracture characteristics, timing and number of surgical procedures, microbiological findings, antimicrobial therapy, and infection-related outcomes.

The study will evaluate clinical and injury-related factors associated with severe wound infection and describe the microbiological spectrum of infections, including multidrug-resistant organisms. Secondary analyses will investigate the association between tissue injury severity and the need for repeated debridement, reconstructive surgery, amputation, prolonged hospitalization, intensive care admission, and mortality.

The results are expected to improve understanding of infection pathogenesis following drone-related combat injuries and provide evidence to support risk stratification, surgical management, infection prevention, and antimicrobial treatment strategies in modern combat trauma. The findings may also contribute to the development of future clinical prediction models and standardized management protocols for patients sustaining drone-related injuries.

Первичные конечные точки

• Incidence of Severe Wound Infection [Срок оценки: From hospital admission through Day 7 after admission.]

Вторичные конечные точки (2)

• Extent of Tissue Devitalization [Срок оценки: During the first operative debridement, performed within 24 hours after hospital admission.]
• Number of Operative Wound Debridements [Срок оценки: From hospital admission through Day 7 after admission.]

Критерии участия

Критерии включения

• Adults aged 18 years or older.
• Combat-related injury caused by a confirmed drone-related mechanism, including first-person view (FPV) drones, drone-delivered explosive munitions, or other unmanned aerial vehicle (UAV)-associated injuries.
• Open extremity injury requiring operative surgical debridement.
• Hospital admission within 24 hours after injury.
• Written informed consent provided by the participant or legally authorized representative, in accordance with local regulations.

Критерии исключения

• Age younger than 18 years.
• Isolated superficial soft tissue injuries not requiring operative treatment. Injuries requiring immediate primary amputation before initial surgical assessment.
• Patients transferred more than 24 hours after injury.
• Pre-existing active infection involving the injured limb before the combat injury.
• Patients who die before completion of the initial surgical debridement.
• Prisoners or other individuals unable to provide informed consent when no legally authorized representative is available.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Украина · 1 центр

• Vinnitsya university hospital — Vinnytsia

Публикации

• Petfield JL, Lewandowski LR, Stewart L, Murray CK, Tribble DR. IDCRP Combat-Related Extremity Wound Infection Research. Mil Med. 2022 May 4;187(Suppl 2):25-33. doi: 10.1093/milmed/usab065. PMID 35512376
• Nowadly CD Maj, Maddry JK Col, Vargas CR CPT, MacDonald AG Capt, Maksimenko YM Maj, Hewitt CW Lt Col, Silverman MB CPT, Sawyer DH Maj, Long BJ Lt Col. The Medical Implications of Emerging Unmanned Aircraft Systems in Military and Combat Environments: A Narrative Review. Mil Med. 2025 Nov 1;190(11-12):e2339-e2349. doi: 10.1093/milmed/usaf189. PMID 40354101

Идентификаторы

NCT: NCT07706608 · 031107-11072026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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