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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-60
SponsorCharitable Organisation Charitable Fund Superhumans (Co Cf Superhumans)

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

150 Participants
are grouped into 1 trial group
Group A: War-Related Trauma With Surgical Wound Management

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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.
2

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.

Other outcomes

Sponsors and contacts

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