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

NCT07475897 | Not Yet Recruiting

• 2 other identifiers: 130303032026Superhumans war trauma center
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Negative Pressure Wound Therapy; War-related trauma; Post-traumatic pain; Neuropathic pain; Chronic pain after trauma; Soft tissue injury

Outcome Measures

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.

  6 months after injury

Secondary Outcomes (2)

• Pain Intensity

  3 months and 6 months after injury.

• Paresthesia

  3 months and 6 months after injury.

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans): lead

Study Sites (1)

Superhumans War Trauma Center

Lviv, Ukraine

Location

Related Publications (1)

• Stannard JP, Volgas DA, Stewart R, McGwin G Jr, Alonso JE. Negative pressure wound therapy after severe open fractures: a prospective randomized study. J Orthop Trauma. 2009 Sep;23(8):552-7. doi: 10.1097/BOT.0b013e3181a2e2b6.

  PMID: 19704269 RESULT

MeSH Terms

Conditions

Pain, Postoperative; Wounds and Injuries; Infections; War-Related Injuries; Neuralgia; Soft Tissue Injuries

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Central Study Contacts

Dmytro Dmitriy Dmytriiev, PhD.Professor

CONTACT

+380674309449; d.dmytriiev@superhumans.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of science department, PhD, Professor

Study Record Dates

• First Submitted: March 13, 2026
• First Posted: March 17, 2026
• Study Start: March 15, 2026
• Primary Completion: March 15, 2026
• Study Completion: March 15, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

UA (1)