An observational study in Phantom Limb Pain After Amputation, Chronic Pain Due to Injury and Postoperative Pain, sponsored by Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans). Completed at 1 site in Ukraine. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans) · Observational
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.
War-related trauma frequently produces complex soft tissue injuries requiring staged surgical management, repeated debridement procedures, and advanced wound care strategies. Negative Pressure Wound Therapy (NPWT) has become a widely used technique in modern trauma care to improve wound healing, control exudate, reduce edema, and prepare wounds for delayed closure or reconstruction. In patients with severe trauma, NPWT is commonly applied following surgical debridement and may be used for several days or weeks depending on wound severity and healing progress.
Although NPWT has well-established benefits in wound management, its relationship with long-term pain outcomes has not been clearly defined. Patients with severe traumatic injuries are at increased risk of developing persistent post-traumatic pain due to extensive tissue damage, repeated surgical interventions, inflammation, and potential peripheral nerve injury. Early clinical factors such as high acute pain intensity, nerve involvement, and repeated surgical manipulation may contribute to peripheral and central sensitization, ultimately increasing the risk of chronic pain.
In trauma populations, NPWT may represent not only a treatment modality but also a clinical marker of injury severity, prolonged wound healing, and repeated surgical procedures. Therefore, evaluating the relationship between NPWT exposure and long-term pain outcomes may help identify patients at higher risk for persistent post-traumatic pain.
This prospective observational cohort study will enroll adult patients with war-related traumatic injuries requiring surgical wound management. Participants will be classified according to whether they received NPWT during their wound treatment. Clinical data related to injury characteristics, early pain intensity, surgical management, and suspected nerve injury will be recorded.
Participants will be followed for six months after injury to assess the development of persistent pain, neuropathic pain symptoms, paresthesia, and pain interference with daily activities. The study will also explore early clinical predictors of chronic pain, including the use and duration of NPWT, number of surgical procedures, acute pain intensity during the first 72 hours after injury, suspected nerve injury, and mechanism of trauma.
By identifying factors associated with persistent post-traumatic pain, this study may improve risk stratification and support the development of early pain prevention and rehabilitation strategies for patients with severe traumatic injuries.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's enrollment of 150 is above the median of 102 across 683 observational studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans) is the lead sponsor of 8 studies on the registry; 5 are open to participants now.
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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.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This cohort includes adult patients with war-related traumatic soft tissue injuries requiring surgical wound management. Patients may receive Negative Pressure Wound Therapy (NPWT) or standard wound care as part of routine clinical treatment. The study is observational and does not mandate any intervention. The primary exposure of interest is the use and duration of NPWT, and participants will be followed prospectively to assess the development of persistent post-traumatic pain and related sensory symptoms up to 6 months after injury.
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.
Time frame: 6 months after injury
Pain Intensity
Pain intensity in the injured region measured using the Numeric Rating Scale (NRS, 0-10).
Time frame: 3 months and 6 months after injury.
Paresthesia
Presence of abnormal sensory sensations such as tingling, numbness, or pins-and-needles in the injured region.
Time frame: 3 months and 6 months after injury.
Plan to share: No — Individual participant data (IPD) will not be publicly shared due to ethical and legal considerations related to sensitive clinical data from patients with war-related trauma. The dataset may contain potentially identifiable health information and details associated with combat injuries. De-identified aggregated data may be made available upon reasonable request to the study investigators and subject to approval by the institutional ethics committee and applicable data protection regulations.
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Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans)