About this trial
War-related trauma frequently causes complex soft tissue injuries that require repeated surgical treatment and advanced wound management techniques such as Negative Pressure Wound Therapy (NPWT). Although NPWT is widely used to promote wound healing and prepare wounds for reconstruction, its relationship with long-term pain outcomes remains unclear.
This prospective cohort study aims to investigate whether the use of NPWT after war-related trauma is associated with an increased risk of persistent post-traumatic pain six months after injury. Adult patients with traumatic soft tissue injuries requiring surgical management will be enrolled and followed for six months.
In addition to NPWT exposure, the study will evaluate several early clinical predictors of chronic pain, including acute pain intensity, number of surgical debridements, suspected nerve injury, and mechanism of trauma. Understanding these predictors may help clinicians identify high-risk patients early and develop targeted strategies for pain prevention and rehabilitation after severe trauma.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
age ≥18 years
war-related trauma (blast injury, fragmentation injury, gunshot wound, burn injury, or crush injury)
traumatic soft tissue injury requiring surgical management
ability to provide informed consent
Disqualifiers
chronic pain in the same anatomical region prior to injury
severe cognitive impairment preventing pain assessment
inability to communicate or complete questionnaires
refusal to participate
Trial population
The study population will include adult patients (≥18 years) with war-related traumatic soft tissue injuries requiring surgical wound management. Participants will be recruited from trauma centers treating combat-related injuries such as blast injuries, fragmentation wounds, gunshot wounds, burns, and crush trauma. Patients may receive Negative Pressure Wound Therapy (NPWT) or standard wound care as part of routine clinical treatment. All participants will be followed prospectively to assess pain outcomes and sensory symptoms for up to 6 months after injury.
Trial design
Cohort
Retrospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Persistent Post-Traumatic Pain
Presence of persistent pain in the injured anatomical region defined as pain intensity ≥3 on a 0-10 Numeric Rating Scale (NRS) at 6 months after trauma. Pain will be assessed during follow-up using the standardized Numeric Rating Scale.
Secondary outcomes
Pain Intensity
Pain intensity in the injured region measured using the Numeric Rating Scale (NRS, 0-10).
Paresthesia
Presence of abnormal sensory sensations such as tingling, numbness, or pins-and-needles in the injured region.
Sponsors and contacts
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