NCT07475897

Negative Pressure Wound Therapy as a Predictor of Persistent Pain After War-Related Trauma

Negative Pressure Wound Therapy as a Predictor of Persistent Pain After War-Related Trauma: A Prospective Cohort Study

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans) · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Phantom Limb Pain After Amputation
• Chronic Pain Due to Injury
• Postoperative Pain
• Trauma (Including Fractures)
• Amputation Stump
• Amputation Stump; Infection

Timeline

• Start date: 2026-03-15
• Primary completion: 2026-03-15
• Completion: 2026-03-15
• First posted: 2026-03-17
• Last updated: 2026-03-18

Locations

1 site across 1 country: Ukraine