- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07706608
DRONE-WOUND Study: Severe Infection After Drone-Related Combat Trauma (DRONE-WOUND)
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.
Studieoversigt
Status
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Dmytro Dmytriiev, PhD.Professor
- Telefonnummer: +380674309449
- E-mail: dmytrodmytriiev@gmail.com
Studiesteder
-
-
Vinnitsa
-
Vinnytsia, Vinnitsa, Ukraine
- Vinnitsya university hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of Severe Wound Infection
Tidsramme: 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.
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Extent of Tissue Devitalization
Tidsramme: 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
Tidsramme: 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.
|
Samarbejdspartnere og efterforskere
Publikationer og nyttige links
Generelle publikationer
- 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.
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 031107-11072026
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
IPD-delingsadgangskriterier
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Infektion
-
Jianfeng XieRekrutteringCLABSI - Central Line Associated Bloodstream InfectionKina
-
Fondazione Policlinico Universitario Agostino Gemelli...Lo.Li.Pharma s.r.lIkke rekrutterer endnuHPV - Anogenital Human Papilloma Virus Infection | Infertilitet
-
Mahidol UniversityAfsluttetCLABSI - Central Line Associated Bloodstream InfectionThailand
-
University of Santiago de CompostelaOsteology FoundationRekruttering
-
University of GaziantepIkke rekrutterer endnuHPV - Anogenital Human Papilloma Virus Infection | Kræft, sund | Sundheds tro model
-
Assiut UniversityIkke rekrutterer endnuCLABSI - Central Line Associated Bloodstream Infection | Perifert indsat central kateter | Umbilical venekateter
-
Institut PasteurRekruttering
-
Centre Hospitalier Universitaire de NiceIkke rekrutterer endnuHealth Care Associated Infection
-
Universidad del DesarrolloAfsluttetHealthcare Associated InfectionChile
-
The University of Texas Health Science Center,...EurofinsAfsluttetOdontogen Deep Space Neck InfectionForenede Stater