About this trial
This study aims to evaluate the relationship between evacuation time, tourniquet use, and the development of post-traumatic stress disorder (PTSD) in patients with combat-related amputations. In the context of modern warfare, prolonged evacuation times and extended tourniquet application may contribute not only to physical injury but also to psychological trauma. The study will prospectively follow patients over 18 months to identify key predictors of PTSD and to assess their interaction.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Ukrainian veterans with combat-related injury (post-February 2022)
Single limb amputation
Admission to rehabilitation within 2-4 months post-injury
Age ≥18 years
Disqualifiers
Prior PTSD diagnosis before current injury
Multiple amputations
Rehabilitation duration >3 months
Return to active military duty before follow-up completion
Trial population
The study population consists of Ukrainian military veterans who sustained combat-related traumatic injuries resulting in a single-limb amputation. Participants are recruited from rehabilitation centres within the Superhumans Center network (Lviv, Dnipro, and Odesa, Ukraine). Eligible participants are adults (≥18 years) who were injured after February 2022 and are admitted to rehabilitation within 2-4 months following injury. The study focuses on individuals with no prior history of post-traumatic stress disorder (PTSD) to allow assessment of incident PTSD related to the current trauma. This population represents patients exposed to high-energy combat injuries, often associated with prolonged evacuation times and the use of hemostatic tourniquets. The cohort is therefore particularly relevant for investigating the relationship between prehospital factors and long-term psychological outcomes. Participants are followed prospectively for 18 months with repeated psychological assessment
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
PTSD severity measured by PCL-5 score
Severity of post-traumatic stress disorder (PTSD) symptoms will be assessed using the PTSD Checklist for DSM-5 (PCL-5), a validated 20-item self-report questionnaire. Each item is scored on a scale from 0 (not at all) to 4 (extremely), with a total score range of 0 to 80, where higher scores indicate greater symptom severity. The primary outcome will be the total PCL-5 score measured longitudinally to evaluate changes in PTSD symptom severity over time and its association with evacuation time and duration of tourniquet use.
Secondary outcomes
Change in PTSD Severity Over Time
Change in PTSD symptom severity measured as the difference in total PCL-5 score between baseline and follow-up assessments. This outcome will evaluate the trajectory of PTSD symptoms over time.
Sponsors and contacts
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