An observational study in Combat Related Symptoms, Combat Trauma and Infection, sponsored by Ukrainian Society of Regional Anesthesia and Pain Therapy. Not yet recruiting at 1 site in Ukraine. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-07-16.
Sponsored by Ukrainian Society of Regional Anesthesia and Pain Therapy · Observational
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.
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.
745 studies on the registry are indexed under Surgical Wound Infection; 151 are open to participants now.
This study's planned enrollment of 500 is above the median of 239 across 135 observational studies indexed under Surgical Wound Infection.
Browse Surgical Wound Infection studies →Ukrainian Society of Regional Anesthesia and Pain Therapy is the lead sponsor of 15 studies on the registry; 9 are open to participants now.
Compared within Surgical Wound Infection, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Infections. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with injuries caused by FPV drones, drone-dropped munitions, or other confirmed drone-related mechanisms.
Patients with other combat injuries, such as conventional blast, mine, artillery-fragmentation, or gunshot injuries.
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.
Time frame: From hospital admission through Day 7 after admission.
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.
Time frame: During the first operative debridement, performed within 24 hours after hospital admission.
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.
Time frame: From hospital admission through Day 7 after admission.
Plan to share: Yes — 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.
Supporting information: Study protocol
Time frame: Data will be available beginning 6 months after publication of the primary study results and will remain available for 3 years thereafter.
Access criteria: 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.
Data sharing details ↗ · uaratb.org
Start is estimated for Oct 2026; primary completion for Oct 2026, 0 months later.
Of 65 non-industry observational studies under Surgical Wound Infection, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 53. This study's planned 0 months is below that.
Counting every sponsor, half of 68 studies reached it within 21 months; a quarter within 9 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Ukrainian Society of Regional Anesthesia and Pain Therapy