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临床试验/NCT07475897
NCT07475897尚未招募不适用

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

Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans)1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2026年3月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
150
试验地点
1
主要终点
Persistent Post-Traumatic Pain

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

War-Related Trauma With Surgical Wound Management

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.

结局指标

主要结局

Persistent Post-Traumatic Pain

时间窗: 6 months after injury

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.

次要结局

  • Pain Intensity(3 months and 6 months after injury.)
  • Paresthesia(3 months and 6 months after injury.)

研究者

发起方
Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans)
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dmytro Dmytriiev

Chief of science department, PhD, Professor

Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans)

研究点 (1)

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