DRONE-WOUND Study: Tissue Devitalization and Severe Infection Following Drone-Related Combat Trauma: A Prospective Multicenter Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Incidence of Severe Wound Infection
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Incidence of Severe Wound Infection
时间窗: From hospital admission through Day 7 after admission.
Severe wound infection will be recorded when a participant develops at least one of the following: deep soft tissue infection, necrotizing soft tissue infection, osteomyelitis, wound infection requiring unplanned operative debridement, or wound-related sepsis. The diagnosis will be established by the treating surgical team using clinical examination, operative findings, microbiological culture results, laboratory findings, and imaging when clinically indicated. The outcome will be reported as the number and percentage of participants who develop severe wound infection.
次要结局
- Extent of Tissue Devitalization(During the first operative debridement, performed within 24 hours after hospital admission.)
- Number of Operative Wound Debridements(From hospital admission through Day 7 after admission.)
研究者
Dmytro Dmytriiev
professor, head of intensive care department
Ukrainian Society of Regional Anesthesia and Pain Therapy
