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Completed
NCT07475897
Negative Pressure Wound Therapy as a Predictor of Persistent Pain After War-Related Trauma
Conditions: Phantom Limb Pain After Amputation, Chronic Pain Due to Injury, Postoperative Pain, Trauma (Including Fractures), Amputation Stump, Amputation Stump; Infection
Sex: All
Ages: 18 Years – 60 Years
Healthy volunteers: No
Enrollment: 150
Sponsor: Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans)
Location: Superhumans War Trauma Center Lviv
Summary
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
Inclusion Criteria:
* 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
* availability for follow-up assessments
Exclusion Criteria:
* 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
* incomplete baseline data or loss to follow-up
Source: ClinicalTrials.gov (NCT07475897). StuddyBuddy aggregates publicly available trial information.