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.

Study Overview

• Status: Not yet recruiting
• Conditions: Infection; Wound - in Medical Care; Infection Complication; Combat Related Symptoms; Combat Trauma; Wound Infection Post-Traumatic; Surgical Site Infection (SSI)

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Dmytro Dmytriiev, PhD.Professor; Phone Number: +380674309449; Email: dmytrodmytriiev@gmail.com

Study Locations

• Ukraine
  • Vinnitsa
    • Vinnytsia, Vinnitsa, Ukraine
      • Vinnitsya university hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From hospital admission through Day 7 after admission.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	From hospital admission through Day 7 after admission.

Collaborators and Investigators

• Sponsor: Ukrainian Society of Regional Anesthesia and Pain Therapy

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): October 23, 2026
• Primary Completion (Estimated): October 23, 2026
• Study Completion (Estimated): October 23, 2026

Study Registration Dates

• First Submitted: July 11, 2026
• First Submitted That Met QC Criteria: July 11, 2026
• First Posted (Actual): July 16, 2026

Study Record Updates

• Last Update Posted (Actual): July 16, 2026
• Last Update Submitted That Met QC Criteria: July 11, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Surgical Site Infection; Wound Infection; Combat Trauma; Antimicrobial Resistance; Soft Tissue Injury; Multidrug-Resistant Organisms; Drone-Related Injury; Tissue Devitalization; Severe Wound Infection
• Additional Relevant MeSH Terms: Wounds and Injuries; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Infections; Surgical Wound Infection; Wound Infection; Soft Tissue Injuries
• Other Study ID Numbers: 031107-11072026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data will be available beginning 6 months after publication of the primary study results and will remain available for 3 years thereafter.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No