Combat Related SymptomsDRONE-WOUNDNCT07706608
DRONE-WOUND Study: Severe Infection After Drone-Related Combat Trauma
An observational study of Combat Related Symptoms and Combat Trauma, run by Ukrainian Society of Regional Anesthesia and Pain Therapy at 1 site in Ukraine.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Combat Related Symptoms, Combat Trauma, Infection
- How many people
- 500 participants
- Where
- 1 siteUkraine
- Study dates
- 23 Oct 2026to 23 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Combat Related Symptoms, Combat Trauma, Infection, Infection Complication, Wound - in Medical Care, Wound Infection Post-Traumatic
- Keywords
- Drone-Related Injury, Combat Trauma, Tissue Devitalization, Wound Infection, Severe Wound Infection, Surgical Site Infection, Multidrug-Resistant Organisms, Antimicrobial Resistance, Soft Tissue Injury
- Medical subject headings
- Infections, Surgical Wound Infection, Necrosis, Wound Infection, Soft Tissue Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From hospital admission through Day 7 after admission.
Secondary outcomes (2)
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.
Measured: 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.
Measured: From hospital admission through Day 7 after admission.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start23 Oct 2026 (estimated)
- Primary completion23 Oct 2026 (estimated)
- Study completion23 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Combat Related SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ukrainian Society of Regional Anesthesia and Pain Therapy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dmytro Dmytriiev, Ukrainian Society of Regional Anesthesia and Pain Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07706608
- Sponsor's protocol ID
- 031107-11072026
- Acronym
- DRONE-WOUND
- Status last verified
- Jul 2026
- First submitted
- 11 Jul 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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.
PubMed 35512376Nowadly 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.
PubMed 40354101
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DRONE-WOUND Study: Tissue Devitalization and Severe Infection Following Drone-Related Combat Trauma: A Prospective Multicenter Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07706608
- Acronym / sponsor ID
- DRONE-WOUND / 031107-11072026
- Conditions
- Combat Related Symptoms, Combat Trauma, Infection, Infection Complication, Wound - in Medical Care, Wound Infection Post-Traumatic
- Keywords
- Drone-Related Injury, Combat Trauma, Tissue Devitalization, Wound Infection, Severe Wound Infection, Surgical Site Infection, Multidrug-Resistant Organisms, Antimicrobial Resistance
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Ukrainian Society of Regional Anesthesia and Pain TherapyUniversity, hospital or other
- Study start
- 23 Oct 2026 (estimated)
- Primary completion
- 23 Oct 2026 (estimated)
- Study completion
- 23 Oct 2026 (estimated)
- First posted
- 16 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Severe Wound Infection
Time frame: 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.
2 secondary outcomes
Extent of Tissue Devitalization
Time frame: During the first operative debridement, performed within 24 hours after hospital admission.
Number of Operative Wound Debridements
Time frame: From hospital admission through Day 7 after admission.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Results publication: PubMed 35512376Petfield 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.
- Results publication: PubMed 40354101Nowadly 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Combat Related Symptoms and Combat Trauma, run by Ukrainian Society of Regional Anesthesia and Pain Therapy at 1 site in Ukraine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dmytro Dmytriiev, PhD.Professor (+380674309449, dmytrodmytriiev@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Severe Wound Infection (time frame: From hospital admission through Day 7 after admission.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07706608, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.