About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
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.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Incidence of Severe Wound Infection
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.
Secondary outcomes
Extent of Tissue Devitalization
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.
Number of Operative Wound Debridements
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.
Sponsors and contacts
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