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

11. července 2026 aktualizováno: Dmytro Dmytriiev, Ukrainian Society of Regional Anesthesia and Pain Therapy

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

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.

Přehled studie

Detailní popis

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.

Typ studie

Pozorovací

Zápis (Odhadovaný)

500

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

    • Vinnitsa
      • Vinnytsia, Vinnitsa, Ukrajina
        • Vinnitsya university hospital

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý

Přijímá zdravé dobrovolníky

Ne

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

The study population will consist of adult patients with combat-related open extremity injuries requiring operative surgical debridement. Participants will be prospectively enrolled into two cohorts according to the mechanism of injury: (1) drone-related combat injuries, including FPV drones and drone-delivered explosive munitions, and (2) non-drone combat injuries, including gunshot, artillery, mine, and conventional blast injuries. Patients will be followed prospectively to evaluate the association between tissue devitalization and severe wound infection.

Popis

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Drone-Related Combat Trauma
Patients with injuries caused by FPV drones, drone-dropped munitions, or other confirmed drone-related mechanisms.
Non-Drone Combat Trauma
Patients with other combat injuries, such as conventional blast, mine, artillery-fragmentation, or gunshot injuries.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Incidence of Severe Wound Infection
Časové okno: 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.
From hospital admission through Day 7 after admission.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Extent of Tissue Devitalization
Časové okno: During the first operative debridement, performed within 24 hours after hospital admission.
The extent of tissue devitalization will be assessed during the first operative debridement by the attending surgeon using a standardized operative form. The surgeon will document the presence and anatomical extent of non-viable skin, subcutaneous tissue, fascia, muscle, and bone involvement. Muscle viability will be assessed using color, consistency, contractility, and bleeding. The outcome will be reported as the number of tissue layers with documented devitalization, ranging from 0 to 5, where higher values indicate more extensive tissue devitalization.
During the first operative debridement, performed within 24 hours after hospital admission.
Number of Operative Wound Debridements
Časové okno: From hospital admission through Day 7 after admission.
The total number of operative wound debridement procedures performed for each participant will be obtained from operative records. A wound debridement is defined as an operation performed to remove devitalized, contaminated, or infected tissue. The initial debridement and all repeat debridements will be included. The outcome will be reported as the total number of procedures per participant.
From hospital admission through Day 7 after admission.

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

23. října 2026

Primární dokončení (Odhadovaný)

23. října 2026

Dokončení studie (Odhadovaný)

23. října 2026

Termíny zápisu do studia

První předloženo

11. července 2026

První předloženo, které splnilo kritéria kontroly kvality

11. července 2026

První zveřejněno (Aktuální)

16. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

16. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

11. července 2026

Naposledy ověřeno

1. července 2026

Více informací

Termíny související s touto studií

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

De-identified individual participant data underlying the published results will be made available upon reasonable request to the corresponding investigator. Shared data will include demographic characteristics, injury characteristics, surgical variables, microbiological findings, and outcome measures used in the analyses. Data will be provided after publication of the primary study results to researchers with a methodologically sound proposal and following approval of a data sharing agreement in accordance with institutional policies and applicable ethical and legal requirements.

Časový rámec sdílení IPD

Data will be available beginning 6 months after publication of the primary study results and will remain available for 3 years thereafter.

Kritéria přístupu pro sdílení IPD

Access to de-identified individual participant data will be provided to qualified researchers upon reasonable request after publication of the primary study results. Requests must include a methodologically sound research proposal. Access will require approval by the study investigators and execution of a data sharing agreement in accordance with applicable ethical and institutional policies.

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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