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

NCT07706608 | Not Yet Recruiting DMC

• 1 other identifier: 031107-11072026
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Combat Related Symptoms; Combat Trauma; Infection; Infection Complication; Wound - in Medical Care; Wound Infection Post-Traumatic; Surgical Site Infection (SSI)

Keywords

Drone-Related Injury; Combat Trauma; Tissue Devitalization; Wound Infection; Severe Wound Infection; Surgical Site Infection; Multidrug-Resistant Organisms; Antimicrobial Resistance; Soft Tissue Injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Extent of Tissue Devitalization

  During the first operative debridement, performed within 24 hours after hospital admission.

• Number of Operative Wound Debridements

  From hospital admission through Day 7 after admission.

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ukrainian Society of Regional Anesthesia and Pain Therapy: lead

Study Sites (1)

Vinnitsya university hospital

Vinnytsia, Vinnitsa, Ukraine

Location

Related Publications (2)

• 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.

  PMID: 35512376 RESULT

• 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.

  PMID: 40354101 RESULT

MeSH Terms

Conditions

Infections; Surgical Wound Infection; Necrosis; Wound Infection; Soft Tissue Injuries

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Central Study Contacts

Dmytro Dmytriiev, PhD.Professor

CONTACT

+380674309449; dmytrodmytriiev@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor, head of intensive care department

Study Record Dates

• First Submitted: July 11, 2026
• First Posted: July 16, 2026
• Study Start (Estimated): October 23, 2026
• Primary Completion (Estimated): October 23, 2026
• Study Completion (Estimated): October 23, 2026
• Last Updated: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

UA (1)